Verification Information.

Children playing in water sprinkler

The Piri range includes Pirinase, Piriton, Piriteze and PiriNatural.

The substantiation for the claim: 'The UK's No.1 selling allergy care brand’/’The UK’s No.1 allergy care range’/’From the UK's No.1 selling allergy care brand/range’/’From Piri, the UK’s No.1 selling allergy care brand/range’ is summarised in the tables below. 

When this claim is used in the context of advertising for the Piri range as a whole, the claim is referring to the fact that the total number of packs purchased for the Piri range (Pirinase, Piriton, Piriteze and PiriNatural) is higher than the total number of packs purchased for any other allergy care brand/range. The table below gives the number of packs sold (unit sales), in the UK, for the ten top selling allergy brands/ranges during the 12-week and one-year period to week ending 27/02/21.

BRAND MAT TY Latest 12 Weeks
ALLERGY 37,444,238.30 4,369,607.80
PIRI RANGE - PIRITON / PIRINATURAL / PIRINASE / PIRITEZE 8,164,904.40 918,380.00
BENADRYL RANGE - BENADRYL / BENACORT 2,763,910.80 254,906.60
BECO RANGE - BECOALLERGY / BECODEFENCE / BECONASE 2,223,911.00 201,046.50
GALPHARM 1,482,562.70 168,268.20
CLARITYN / CLARINAZE 1,429,165.30 110,854.50
ALLACN 1,149,347.70 157,744.30
BELLS 933,164.70 101,487.00
OPTICROM 776,811.40 68,831.80
OPTREX 467,186.60 46,465.20
PHENERGAN 425,680.90 103,655.70

Source: Nielsen Scantrack Data Total Coverage GB, Unit Sales. WE 27.02.21

When the claim, 'The UK's No.1 selling allergy care brand’ is used in the context of advertising for Piriteze only, the claim is referring to the fact that more packs of Piriteze Allergy Tablets and Piriteze Allergy Syrup are purchased than any other allergy care brand. The table below gives the number of packs sold (unit sales), in the UK, for the top ten selling allergy brands during the 12-week and one-year period to week ending 27/02/2021.

BRAND MAT TY Latest 12 Weeks
PIRITEZE 5,107,196.80 482,228.20
BENADRYL 2,742,112.00 251,803.80
PIRITON 2,403,242.20 373,032.60
BECONASE 1,689,009.80 142,552.30
CLARITYN 1,394,459.50 104,739.10
ALLACAN 1,149,347.70 157,744.30
GALPHARM 1,117,084.40 130,111.20
BELLS 933,165.10 101,486.60
OPTICROM 776,811.50 68,831.90
PIRINASE 551,980.00 46,791.90

Source: Nielsen Scantrack Data Total Coverage GB, Unit Sales. WE 27.02.21

The substantiation for the claim: 'The UK's No.1 allergy relief tablet' is summarised in the table below. The claim refers to Piriteze Allergy Relief Tablets. The table gives the number of packs sold (unit sales), in the UK, for the top ten selling allergy tablet products during the 12-week and one-year period to week ending 27/02/2021.

BRAND PRODUCT PROPERTY   FORM MAT TY Latest 12 Weeks
PIRITEZE ALLERGY TABLETS 4,586,542 402,680
CLARITYN ALLERGY TABLETS 1,427,715 236,921
PIRITON ALLERGY TABLETS 1,384,153 97,299
ALLACAN HAY FEVER & ALLERGY RELIEF TABLETS 1,151,689 153,055
GALPHARM ALLERGY & HAYFEVER RELIEF TABLETS 870,232 59,446
BELLS HAYFEVER & ALLERGY TABLETS 814,187 85,684
BENADRYL ALLERGY TABLETS 668,193 119,322
GALPHARM CETIRIZINE TABLETS 363,037 38,573
BELLS ALLERGY RELIEF TABLETS 223,183 25,256
PHENERGAN TABLETS 87,987 6,698

Source: Nielsen Scantrack Data Total Coverage GB, Unit Sales. WE 27.02.21

The substantiation for the claim: 'The UK's No.1 selling allergy syrup’ is summarised in the table below. The claim refers to Piriton Syrup. The table gives the number of packs sold (unit sales), in the UK, for the top ten selling allergy syrup products during the 12-week and one-year period to week ending 27/02/2021.

BRAND PRODUCT PROPERTY   FORM MAT TY Latest 12 Weeks
PIRITON ALLERGY SYRUP 984,012 130,824
PIRITEZE ALLERGY SYRUP 520,672 66,270
ZIRTEK ALLERGY SYRUP 11,207 1,162
UNICHEM LORATADINE SYRUP 10,553 614
PINEWOOD SYRUP 2,859 221
ALLERIEF SYRUP 1,969 126
LORATADINE SYRUP SYRUP 640 77
ALMUS CHLORPHENA MALEATE SYRUP 231 0
CLARITYN ALLERGY SYRUP 63 59
ALL OTHER SYRUP N/A N/A

Source: Nielsen Scantrack Data Total Coverage GB, Unit Sales. WE 27.02.21

Claim Verification Information for Pirinase Hayfever Relief for Adults 0.05% Nasal Spray and Pirinase Allergy 0.05% Nasal Spray

The UK Codes of Non-broadcast and Broadcast Advertising (the CAP and BCAP Codes) require that advertisers provide sufficient information, about comparisons with identifiable competitor products, to enable consumers to check the comparison for themselves.

GSK is currently using the claim ‘No spray is stronger for…’ (see iterations below) on various Pirinase Hayfever and Pirinase Allergy promotional materials.

Claim Iterations Relevant Product
No spray is stronger for hay fever relief, including itchy & watery eyes Pirinase Hayfever (GSL)
Pirinase Allergy (P)
 
No spray is stronger for treating allergy symptoms* Pirinase Hayfever (GSL)
Pirinase Allergy (P)
No spray is stronger for preventing or treating allergy symptoms* Pirinase Allergy (P)

No spray is stronger for treating allergy symptoms*, even before they start

*from airborne allergies

Pirinase Allergy (P)
No spray is stronger at preventing and treating airborne allergy symptoms for up to 24 hours. Pirinase Allergy (P)

Can have either ‘allergy symptoms*’ (*from airborne allergies) or ‘airborne allergies’ in claim]

The claim is supported by the evidence summarised below.

Introduction

Pirinase Hayfever Relief for Adults 0.05% Nasal Spray and Pirinase Allergy 0.05% Nasal Spray contain fluticasone propionate, a once daily intranasal corticosteroid.
Pirinase Hayfever Relief for Adults 0.05% Nasal Spray is indicated for the relief of allergic rhinitis, such as hay fever symptoms1.
Pirinase Allergy 0.05% Nasal Spray is indicated for the for the prevention and relief of allergic rhinitis, such as hay fever symptoms2.

Supporting data

To support the above claims, GSK reviewed all medicines with an allergy relief and/or prevention indication in a spray format available without prescription in the UK.

There are a range of Hay fever relief actives available in spray format without prescription that can be used to relieve and/or prevent the symptoms of hay fever, including nasal decongestants and other intranasal corticosteroids.

Medicines indicated for allergy relief in a spray format were identified using a number of sources including eMC3, MHRA database4 and PAGB OTC Handbook5.To ensure that only non‐prescription products were included, the legal classification of the product was determined using eMC3 and MHRA database4.

The results of the searches can be found in Table 1.
Maximum doses for the active ingredients are detailed in Table 2, using information available in the Association of the European Self‐Medication Industry (AEGSP) database6 for OTC ingredients and the MHRA’s list C7, which was archived in Dec 2014.

Table 1: OTC Medicinal Sprays available for relief and/or prevention of Hay fever or allergy symptoms 

Product Licence Holder Licence Active Strength
Beclometasone Dipropionate Aqueous Nasal Spray, Nasobec Hayfever Teva UK limited PL 00289/1607 Beclometasone Dipropionate 50 Mcg/spray
Beconase Hayfever Omega Pharma PL 02855/0064 Beclometasone  50 Mcg/spray

Beconase Hayfever Relief For Adults 0.05% Nasal Spray

Omega Pharma

PL 02855/0065

Beclometasone
Dipropionate

50 Mcg/spray

Benacort 64 Micrograms
Nasal Spray

Mcneil Products
Limited

PL 15513/0404

Budesonide

64mcg/Spray

Benacort 64 Micrograms
Nasal Spray

Mcneil Products
Limited

PL 15513/0404

Budesonide

64mcg/Spray

Benacort Hayfever Relief for Adults 64 micrograms, nasal spray

McNeil Products Ltd

PL 15513/0409

Budesonide

64mcg/Spray

Boots Allergy Relief 50 microgram Nasal Spray

The Boots Company plc

00289/1609

Fluticasone Propionate

0.05%

Boots Blocked Nose Relief 0.05% w/v Nasal Spray

The Boots Company PLC

PL00014/0292

Oxymetazoline Hydrochloride

0.05%

Boots Decongestant 0.05% w/v Nasal Spray

The Boots Company PLC

PL 16028/0049

Oxymetazoline Hydrochloride

0.05%

Boots Hayfever Relief 50 microgram Nasal Spray

The Boots Company PLC

PL 16431/0121

Beclometasone dipropionate

50 Mcg /spray

Boots Hayfever Relief For Adults 50mcg/Dose Nasal
Spray

The Boots
Company PLC

PL 16431/0176

Beclometasone
Dipropionate

50 Mcg /spray

Clarinaze Allergy Control 0.05% Nasal Spray

Bayer PLC

PL 00010/0663

Mometasone furoate

50 Mcg/spray

Flixonase 0.05% Nasal Spray

GlaxoSmithKline
Consumer
Healthcare

PL 44673/0101

Fluticasone
Propionate

0.05%

Fluticasone Propionate 50 micrograms/actuation Nasal Spray Suspension

GlaxoSmithKline
Consumer
Healthcare

PL 44673/0102

Fluticasone
Propionate

0.05%

JML Hayfever Relief Spray 50 micrograms / dose Nasal Spray

Ayrton Saunders Limited

PL 16431/0121

Beclometasone Dipropionate

50 Mcg/spray

Nasacort Allergy 55 micrograms/dose Nasal Spray suspension

Sanofi

PL 04425/0605

Triamcinolone acetonide

55mcg/spray

NASONEX Nasal Spray 0.05%


Bayer PLC

PL 00010/0663

Mometasone furoate

50 Mcg/spray

Otrivine Adult Measured Dose Sinusitis Spray

GlaxoSmithKline
Consumer
Healthcare

PL 44673/0184

Xylometazoline Hydrochloride

0.1%

OTRIVINE Adult Menthol Nasal Spray

GlaxoSmithKline
Consumer
Healthcare

PL 44673/0152

Xylometazoline Hydrochloride

0.1%

Otrivine Adult Metered Dose 0.1% Nasal Spray

GlaxoSmithKline
Consumer
Healthcare

PL 44673/0184

Xylometazoline Hydrochloride

0.1%

Otrivine Adult Nasal Spray

GlaxoSmithKline
Consumer
Healthcare

PL 44671/0149

Xylometazoline Hydrochloride

0.1%

Otrivine Allergy Relief 0.1% Nasal Spray

GlaxoSmithKline
Consumer
Healthcare

PL 44673/0184

Xylometazoline Hydrochloride

0.1%

Otrivine Congestion Relief 0.1% Nasal Spray

GlaxoSmithKline
Consumer
Healthcare

PL 44673/0151

Xylometazoline Hydrochloride

0.1%

Pirinase Allergy
Nasal Spray 0.05%

GlaxoSmithKline
Consumer
Healthcare

PL 44673/0099

Fluticasone
Propionate

0.05%

Pirinase Hayfever Relief
Nasal Spray 0.05%

GlaxoSmithKline
Consumer
Healthcare

PL 44673/0100

Fluticasone
Propionate

0.05%

Rhinolast Allergy Nasal Spray 0.1% w/v

Mylan Products Limited

PL 46302/0083

Azelastine hydrochloride

0.1%

140mcg/spray

Sudafed Blocked Nose Spray

McNeil Products Ltd

PL 15513/0074

Xylometazoline Hydrochloride

0.1%

Sudafed Congestion Relief 0.1% Nasal Spray, solution

McNeil Products Ltd

PL 15513/0368

Xylometazoline Hydrochloride

0.1%

Sudafed Sinus-Ease 0.1% Nasal Spray

McNeil Products Ltd

PL 15513/0074

xylometazoline hydrochloride

0.1%

Table 2 – Maximum OTC doses of Identified Active Ingredients

Active Ingredient Max. OTC Strength Available

Azelastine hydrochloride

140mcg/spray (1 spray dose)

Beclometasone Dipropionate

Maximum dose 100 micrograms per nostril 50mcg/spray (2 spray)

Budesonide

Maximum dose 200 micrograms per nostril 100mcg/spray (2 spray)

Fluticasone Propionate

0.05%

Mometasone furoate

0.05%

Triamcinolone acetonide

Maximum dose and maximum daily dose of 110 micrograms per nostril
55mcg/spray (2 spray)

Xylometazoline Hydrochloride

0.1%

Conclusion

Based on the information presented in this document, there is no product available over the counter which is stronger than Pirinase Hay Fever Relief for Adults 0.05% Nasal Spray and Pirinase Allergy 0.05% Nasal Spray for the relief and/or prevention of allergy and hay fever symptoms.

This is supported by a significant data review capturing Pharmacy only and GSL medicines indicated for allergy relief and reviewing the quantities of the active ingredients in the products meeting the maximum dose as outlined by AEGSP and the MHRA’s list or approved reclassifications.

From this data, GSK believe that the above claims are adequately supported.

References

  1. Pirinase Hayfever Relief for Adults 0.05% Nasal Spray SPC 
    https://www.medicines.org.uk/emc/product/5116/smpc. Accessed April 2021
  2. Pirinase Allergy 0.05% Nasal Spray SPC 
    https://www.medicines.org.uk/emc/product/4502/smpc. Accessed April 2021
  3. Medicines.org.uk. Accessed April 2021.
  4. MHRA RAMA XL Database. Allergy Relief/Prevention Products. Accessed April 2021. 
    https://services.intralinks.com/
  5. PAGB OTC Directory Online. Accessed April 2021
    https://www.otcdirectory.co.uk/
  6. Association of the European Self‐Medication Industry (AEGSP) database. April 2021. 
    https://otc.aesgp.eu/
  7. Approved Reclassifications. MHRA Archive. Accessed April 2021.

Claim Verification Information for Pirinase Relief for Adults 0.05% Nasal Spray and Pirinase Allergy 0.05% Nasal Spray

GSK is currently using the claim ‘Nothing is more effective for hay fever relief than Pirinase’ on various Pirinase promotional materials.

The claim is supported by the evidence summarised below.

Summary

Pirinase Allergy 0.05% Nasal Spray (P) and Pirinase Hay fever Relief for Adults 0.05% Nasal Spray (GSL) contain fluticasone propionate (FP) and are once daily intranasal corticosteroid sprays (INCS) available over the counter (OTC).

The overwhelming body of evidence demonstrate that INCS, such as FP, provide equivalent relief and in some cases superior relief to antihistamines, decongestants, eye drops and decongestant agents in the treatment of allergic rhinitis (AR) symptoms. As a result of this efficacy, INCS are considered the first line treatment for AR by a large number of important practice parameters. The efficacies of the different INCS are considered to be comparable, with differences limited to factors like patient preference, dosing regimens, and the delivery device and vehicle 1-5.

Based on this evidence, we consider the following top parity claim for Pirinase Allergy 0.05% Nasal Spray (P) and Pirinase Hayfever Relief for Adults 0.05% Nasal Spray to be supportable:

‘Nothing is more effective for hay fever relief than Pirinase’

Background

Allergic rhinitis is caused by the immune system reacting to irritants or allergens by releasing histamine and other chemicals. This causes symptoms include sneezing, nasal congestion, runny nose, red/itchy/watery eyes, and nasal secretions which may be classed as persistent or intermittent.Common allergens that cause allergic rhinitis include pollen (this type of allergic rhinitis is known as hay fever), as well as mould spores, house dust mites, and flakes of skin or droplets of urine or saliva from certain animals.

There are a range of ingredients available without a prescription that can be used to relieve the symptoms of hay fever, including nasal decongestants (xylometazoline and oxymetazoline), antihistamine tablets (e.g. cetirizine, acrivastine) and other intranasal corticosteroids (e.g. beclomethasone, budesonide, triamcinolone).

‘Pirinase Hayfever Relief for Adults 0.05% Nasal Spray’ and ‘Pirinase Allergy 0.05% Nasal Spray’ contain the active ingredient fluticasone propionate. Pirinase Allergy 0.05% Nasal Spray is  licenced for the prevention and treatment of AR including hay fever and that caused by other airborne allergens such as house dust mite and animal dander.6 Pirinase Hayfever Relief for Adults 0.05% Nasal Spray’ is used to treat the allergic symptoms of hay fever.7  When used as directed, Pirinase  has an anti-inflammatory action and works in a similar way to natural body chemicals to control the  body’s reactions to allergens (‘triggers’) in the environment.6,7

Active ingredients used to treat hay fever/Allergic Rhinitis

Table 1 (below) shows the active ingredients available OTC for the treatment of allergic rhinitis.

 

Table 1.  Active ingredients available OTC for the treatment of allergic rhinitis§

Active ingredient Treatment Type Indication Dosage Instruction
*Fluticasone propionate Intranasal corticosteroid (Prophylaxis**) and treatment of allergic rhinitis 100 micrograms in each nostril once daily
Beclomethasone (beclometasone) dipropionate Intranasal corticosteroid Prophylaxis and treatment of allergic rhinitis 100 micrograms into each nostril twice daily
Budesonide Intranasal corticosteroid Prophylaxis and treatment of allergic rhinitis Two applications of 64 micrograms into each nostril each morning or one application of 64 micrograms into each nostril morning and evening
*Triamcinolone acetonide Intranasal corticosteroid Prophylaxis and treatment of allergic rhinitis 110 micrograms into each nostril once daily
Azelastine hydrochloride Intranasal antihistamine Symptomatic treatment of seasonal allergic rhinitis or perennial allergic rhinitis 140 micrograms twice daily
Sodium cromoglycate intranasal cromoglycate Prevention and treatment of perennial allergic rhinitis and hay fever One spray into each nostril four to six times daily.
Acrivastine Oral non-sedating antihistamine Symptomatic relief of allergy such as hay fever, urticaria 8 mg three times daily
*Cetirizine hydrochloride Oral non-sedating antihistamine Symptomatic relief of allergy such as hay fever, urticaria 10 mg daily
*Loratadine Oral non-sedating antihistamine Symptomatic relief of allergy such as hay fever, urticaria 10 mg daily
Chlorpheniramine (chlorphenamine) Maleate Oral sedating antihistamine Symptomatic relief of allergy such as hay fever, urticaria 4 mg every 4-6 hours
Diphenhydramine Oral sedating antihistamine

Treatment of allergic conditions e.g. hay fever, vasomotor rhinitis, stings, urticaria, angioneurotic oedema, drug sensitivity, contact dermatitis and photosensitivity

1 or 2 tablets three or four times per day
Promethazine hydrochloride Oral sedating antihistamine Symptomatic relief of allergy such as hay fever, urticaria 25 mg at night or 10-25 mg twice daily
Pseudoephedrine Oral decongestant Symptomatic relief of allergic rhinitis

60 mg every 4-6 hours

[1 tablet every 12 hours]

Oxymetazoline Intranasal decongestant  Symptomatic relief of congestion of the upper respiratory tract due to the common cold, hay fever and sinusitis. 1-2 sprays per nostril every 6-8 hours
Xylometazoline hydrochloride Intranasal decongestant symptomatic relief of nasal congestion, perennial and allergic rhinitis (including hay fever), sinusitis One application in each nostril 1 to 3 times daily
Clemastine hydrogen fumarate Oral antihistamine Allergic rhinitis, including hay fever and perennial rhinitis, vasomotor rhinitis 1mg clemastine base (one tablet) night and morning.
Acrivastine plus pseudoephedrine Oral antihistamine and decongestant  Allergic rhinitis  8 mg acrivastine and 60 mg pseudoephedrine hydrochloride.
Oral. One capsule as necessary, up to three times a day.
Triprolidine hydrochloride plus Pseudoephedrine Hydrochloride. Oral antihistamine and decongestant

For the symptomatic relief of upper respiratory tract disorders which are benefited by a combination of a nasal decongestant and histamine H1-receptor antagonist, for example:

Allergic Rhinitis

Vasomotor Rhinitis

The Common Cold and Influenza

2.5 mg triprolidine hydrochloride and 60 mg pseudoephedrine Hydrochloride.

Oral. One tablet every 4-6 hours up to 4 times a day.

*Chlorphenamine plus ephedrine Oral antihistamine and decongestant Symptomatic relief of allergic conditions such as hay fever, allergic rhinitis, perennial rhinitis, urticaria etc. which are responsive to antihistamine. One or two tablets daily

* once daily products

** GSL and P products available - Indication only for Pharmacy product

§ Source: search of RAMA (a regulatory database) for the indications hay fever and allergic rhinitis, together with their dosing

Fluticasone propionate vs antihistamines

Antihistamines are commonly used to treat allergic rhinitis. These medications counter the effects of histamine, the irritating chemical released within your body when an allergic reaction takes place. Antihistamines are available as oral, intranasal and eye preparations.5

A large number of randomised controlled trials investigating the effectiveness of once daily treatment with fluticasone propionate against currently available antihistamines, including loratadine and cetirizine, determined that fluticasone propionate was more effective than antihistamines in the treatment of the nasal symptoms of allergic rhinitis. 8-12

Antihistamines begin exerting their effect approximately 1-3 hours post dose,13 whilst relief of AR symptoms occur within 3-12 hours of treatment with fluticasone propionate.14  However, in an “as needed” study, fluticasone was shown to be more effective than loratadine in treating AR symptoms regardless of the time to symptom relief.11

In 2008, the Standards of Care Committee (SOCC) of the British Society for Allergy and Clinical Immunology (BSACI) produced guidelines based on evidence and expert opinion. The guidelines state that meta-analysis shows INCSs are superior to antihistamines and that all INCSs display similar clinical efficacy. INCSs were recommended as first-line therapy for moderate to severe persistent symptoms.5

Further, the superiority of fluticasone propionate versus antihistamines when treating allergic rhinitis symptoms has been reported in an extensive number of important review and practice guidelines.13-21

Walls RS et al. (2005)20, in a clinical update, discuss the optimized management of allergic rhinitis where INCS are considered the most effective therapy and are considered first-line treatment for persistent AR and moderate to severe intermittent AR in adults. In systemic reviews and meta-analyses INCS were shown to be superior to AH in controlling nasal symptoms of AR. Further, the author’s state there is no clear evidence that one INCS preparation is more effective than another.

Waddell AN et al. (2003)22, in a meta-analysis of randomized controlled trials comparing the efficacy of intranasal corticosteroids and oral antihistamines in the treatment of allergic rhinitis, showed a clear benefit in favour of intranasal steroids in relieving nasal symptoms and that there was no clear evidence to support the suggestion that one steroid spray was more effective than another in the treatment of seasonal or perennial allergic rhinitis.

Fluticasone propionate vs other active ingredients

The body of evidence confirms the superiority of intranasal corticosteroids (INCS) in the treatment of allergic rhinitis symptoms. Key findings and recommendations are summarised below:

Decongestants are taken by mouth or as a nasal spray or drops. They help shrink the lining of the nasal passages which helps relieves nasal stuffiness associated with allergic rhinitis. They may be useful for short-term treatment of allergic rhinitis to relieve severe nasal congestion.23

OTC saline nasal sprays/washes help counteract symptoms such as thick nasal mucus caused by AR.

Wallace DV et al. (2008)2, in a practice parameter, reported the relative efficacy of INCS against other currently available AR treatments. The author’s rated INCS as more effective than the intranasal antihistamines as well as the combination of an antihistamine and a leukotriene antagonist in the treatment of AR. The authors also state that INCS provide significant relief of seasonal AR when used not only on a regular basis but also on an as-needed basis and that this clinical response does not differ significantly between INCS preparations. This is further evidenced by a comparison of intranasal beclomethasone and fluticasone propionate in AR by Quinitilianni R (1995)24 which showed these agents to be equivalent.

In another practice parameter by Lambert M. (2009),25 INCSs are reported to be the most effective medications for controlling AR symptoms and may be used on an as-needed or regular basis. The author reports that they are more effective than intranasal chromlyn sodium, intranasal cholinergics (which are mainly effective against runny nose), as well as the combination of anti-leukotrienes and antihistamines.

A review by Gandhi RK et al. (2005)26 adds further support to the claim by detailing the relative efficacy of INCS. The authors describe cromolyns as being effective in controlling early phase symptoms however less effective at relieving nasal congestion; anticholinergic agents are useful in treatment of runny nose when INCS do not fully control this symptom; decongestant are effective only for short term use owing to their side-effect profile;  and, in a meta-analysis comparing INCS with antihistamines in the treatment of AR, concluded that INCS were more effective at treating all nasal symptoms of AR including obstruction, sneezing, itching and discharge. The authors concluded that INCS are the most effective agents for treatment of AR and should be used as the first line treatment for moderate to severe AR.

In the Nielsen LP et al. (2001)16 review comparing INCSs and antihistamines (primarily antihistamines such as cetirizine and acrivastine) for the treatment of allergic rhinitis, INCSs offered superior relief. The currently available comparative data on the efficacy of INCS and AH clearly support INCS as more effective in the relief of nasal symptoms in patients with allergic rhinitis. This review supports the notion that INCS offer superior relief for the symptoms of allergic rhinitis.

Finally, in a review of fluticasone against sodium cromoglycate, Ratner PH et al. (2002)27 found intranasal corticosteroids to be more effective than sodium cromolyn (cromoglycate) for the treatment of allergic rhinitis.

Fluticasone propionate vs other intranasal corticosteroid

Intranasal corticosteroids work by suppressing multiple inflammatory mediators like histamines and leukotrienes.5 There are other intranasal corticosteroids available in the UK without a prescription in addition to fluticasone propionate. They can significantly reduce nasal congestion as well as sneezing, itching and a runny nose. Numerous clinical guidelines and review articles recognise intranasal corticosteroids as the most effective treatment option for AR/Hay fever with equivalent or superior efficacy to other treatment types available OTC. 28-34

In their clinical guideline on the diagnosis and management of rhinitis, Wallace et al 2 state:

“When comparing the available intranasal corticosteroids, the overall clinical response does not appear to vary significantly between products irrespective of the differences in topical potency, lipid solubility, and binding affinity.”

In conclusion, the overwhelming body of evidence demonstrates that intranasal corticosteroids provide equivalent relief and in some cases are superior to antihistamines, decongestants, sodium cromoglycate and anti-cholinergic agents in the treatment of AR symptoms. Further, the efficacies of the differing INCS have been demonstrated to be equivalent.

Conclusion

Based on the above information, it can be concluded that no other product available OTC is more effective than Pirinase Allergy 0.05% Nasal Spray (fluticasone propionate) or Pirinase Hayfever Relief for Adults 0.05% Nasal Spray for the relief of hay fever symptoms.

References

  1. Trangsrud AJ et al. Intranasal Corticosteroids for Allergic Rhinitis. Pharmacotherapy. 2002; 22(11): 1458–1467
  2. Wallace DV et al. The diagnosis and management of rhinitis: An updated practice parameter. J Allergy Clin Immunol. 2008;122:S1-84
  3. Waddell AN et al. Intranasal steroid sprays in the treatment of rhinitis: is one better than another? The Journal of Layngology & Otology. 2003; 117: 843-845
  4. Walls RS. Optimising the management of allergic rhinitis: an Australian perspective. MJA. 2005; 182: 28-33
  5. Scadding GK et al. BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007). Clin Exp Allergy. 2017;47:856–889.
  6. Pirinase Allergy 0.05% Nasal Spray Patient Information Leaflet
    https://www.medicines.org.uk/emc/files/pil.4502.pdf Accessed July 2020
  7. Pirinase Hayfever Relief for Adults 0.05% Nasal Spray Patient Information Leaflet
    https://www.medicines.org.uk/emc/files/pil.5116.pdf Accessed July 2020
  8. Charpin D and Vervloet D. “Treating seasonal rhinitis: Antihistamines or intranasal corticosteroids?” Eur Respir Rev 1994; 4(20): 256-259.
  9. Howard KB, Bowers BW, Cook CK, Westlund R, Rickard K. “Intranasal fluticasone, loratadine tablets, and their use in combination: an evaluation in of economic and humanistic outcomes”. Drug Benefit Trends 2001; Oct: 46-52.
  10. Karaman O, Gunbay A, Uzuner N, Gunbay U, Gulay Z, Serioglu S, Yuluga N. “The comparison of the efficacy of fluticasone propionate with cetirizine in perennial allergic rhinitis”. Allergol et Immunopathol 2001; 29:55-59.
  11. Kaszuba SM, Baroody FM, deTineo M, Haney L, Blair C, Naclerio M. “Superiority of an Intranasal Corticosteroid Compared With an Oral Antihistamine in the As-Needed Treatment of Seasonal Allergic Rhinitis”. Arch Intern Med. 2001;161:2581-2587.
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Claim's verification for Piriteze Allergy Tablets no one-a-day tablet provides faster hayfever relief

Piriteze Allergy Tablets contain the antihistamine cetirizine hydrochloride and are available without prescription.  Piriteze Allergy Tablets are indicated for adults and children over 6 years of age  for the relief of symptoms of seasonal allergic rhinitis (SAR also referred to as  hayfever ) and perennial allergic rhinitis (PAR) and for the relief of chronic idiopathic urticaria, at a dose of 10 mg once daily (or 5 mg twice daily for children aged 6-12 years)1.

To support the proposed claim ‘No one-a-day tablet provides faster hayfever relief’, a review of allergy tablets available without prescription and their Summaries of Product Characteristics (SPCs) and relevant clinical data available in the public domain was conducted.  The British National Formulary (BNF)and the electronic Medicines Compendium (eMC)3 were searched to identify tablet format products with once daily dosing, available without prescription for the treatment of allergies.

The search identified 4 active ingredients with once daily oral administration in tablet format that were available without prescription. The results are presented in Table 1 below.

 

Table 1 - Active ingredients available OTC in tablet form for the relief of allergy symptoms

Active Ingredient Indication DosageI
nstruction
Pharmacokinetics/ Pharmacodynamic relevant to faster allergy relief claims
Cetirizine hydrochloride
10 mg1

Relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis.

relief of chronic idiopathic urticaria.

10 mg OD (1 tablet once daily) in patients aged >12 years

5 mg BD in patients aged 6-12 years

5.2 of the SPC states Pharmacokinetic properties Peak blood levels in the order of 0.3µg/ml are reached within about one hour after the oral administration of cetirizine

 

Loratadine
10 mg4

Symptomatic

treatment of allergic

rhinitis and chronic

idiopathic urticaria

10 mg OD (1 tablet once daily) in patients aged >12 yrs

 

10 mg OD in patients aged 2-12 years & weight >30 kg

 

Section 5.1 of the SPC states:  Human histamine skin wheal studies following a single 10 mg dose has shown that the antihistamine effects are seen within 1-3 hours reaching a peak at 8-12 hours and lasting in excess of 24 hours.
Promethazine
hydrochloride
25 mg5

Symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign Proteins.

Initial dose: 25mg OD (1 tablet once daily) in patients aged >10 years

25 mg OD in patients aged 5-10 years

 

No data

Fexofenadine hydrochloride 120 mg6

For the relief of symptoms associated with seasonal allergic rhinitis.

120mg (1 tablet) once daily taken before meals for patients 12 years and over.

Section 5.1  States Human histamine wheal and flare studies following single and twice daily doses of fexofenadine demonstrate that the medicinal product exhibits an antihistaminic effect beginning within one hour, achieving maximum at 6 hours and lasting 24 hours

Key: OD: Once daily                            BD: Twice Daily

Comparison of active ingredients

Literature Search

A literature search was conducted in March 2021 using ProQuest (Embase, MEDLINE, Derwent Drug File, ToxFile) and PubMed databases to source-controlled studies for cetirizine compared to loratadine , fexofenadine and promethazine using the strategy in Table 2 

Studies identified showed once daily cetirizine to exhibit faster onset of action than once daily loratadine in subjects with seasonal allergic rhinitis (SAR). Clinical studies comparing cetirizine to fexofenadine reveal both drugs exhibit comparable onset of action. We did not identify  clinical studies which compare the onset of action of cetirizine with promethazine in subjects with allergic rhinitis symptoms

Search query Search String Databases Hits

Cetirizine versus loratadine

(MJEMB.EXACT("Cetirizine") OR MJMESH.EXACT("Cetirizine") OR ti,ab(Cetirizin* OR Cetrizin* OR Zyrtec OR Virlix OR Zirtec OR Piriteze)) AND (MJEMB.EXACT("Loratadine") OR MJMESH.EXACT("Loratadine") OR ti,ab(loratadine OR loratidine OR claritin OR clarity* OR alavert)) AND ti,ab(Allerg* OR rhinitis OR “hay fever”) AND (MJEMB.EXACT.EXPLODE("CLINICAL TRIAL") OR MJEMB.EXACT.EXPLODE("CLINICAL TRIAL (TOPIC)") OR EMB("CLINICAL TRIAL*" OR "SINGLE BLIND PROCEDURE" OR "DOUBLE BLIND PROCEDURE" OR "TRIPLE BLIND PROCEDURE" OR "CROSSOVER PROCEDURE" OR "RANDOMIZED CONTROLLED TRIAL") OR DTYPE("CLINICAL TRIAL*" OR "CONTROLLED CLINICAL TRIAL" OR "MULTICENTER STUDY" OR "RANDOMIZED CONTROLLED TRIAL" OR "EQUIVALENCE TRIAL") OR ti,ab("clinical trial*" OR "clinical stud*" OR "comparative study" OR randomi?ed OR "double-blind*" OR "controlled?study" OR observational OR cross?sectional OR cohort OR longitudinal OR case?control OR prospective OR retrospective))

ProQuest (Embase, MEDLINE, Derwent drug file, Toxfile)

260

Cetirizine versus fexofenadine

(MJEMB.EXACT("Cetirizine") OR MJMESH.EXACT("Cetirizine") OR ti,ab(Cetirizin* OR Cetrizin* OR Zyrtec OR Virlix OR Zirtec OR Piriteze)) AND (MJEMB.EXACT("Fexofenadine") OR MJMESH.EXACT("Fexofenadine") OR ti,ab(fexofenadine OR allegra)) AND ti,ab(Allerg* OR rhinitis OR “hay fever”) AND (MJEMB.EXACT.EXPLODE("CLINICAL TRIAL") OR MJEMB.EXACT.EXPLODE("CLINICAL TRIAL (TOPIC)") OR EMB("CLINICAL TRIAL*" OR "SINGLE BLIND PROCEDURE" OR "DOUBLE BLIND PROCEDURE" OR "TRIPLE BLIND PROCEDURE" OR "CROSSOVER PROCEDURE" OR "RANDOMIZED CONTROLLED TRIAL") OR DTYPE("CLINICAL TRIAL*" OR "CONTROLLED CLINICAL TRIAL" OR "MULTICENTER STUDY" OR "RANDOMIZED CONTROLLED TRIAL" OR "EQUIVALENCE TRIAL") OR ti,ab("clinical trial*" OR "clinical stud*" OR "comparative study" OR randomi?ed OR "double-blind*" OR "controlled?study" OR observational OR cross?sectional OR cohort OR longitudinal OR case?control OR prospective OR retrospective))

ProQuest (Embase, MEDLINE, Derwent drug file, Toxfile)

142

Cetirizine versus promethazine

(MJEMB.EXACT("Cetirizine") OR MJMESH.EXACT("Cetirizine") OR ti,ab(Cetirizin* OR Cetrizin* OR Zyrtec OR Virlix OR Zirtec OR Piriteze)) AND (MJEMB.EXACT("Promethazine") OR MJMESH.EXACT("Promethazine") OR ti,ab(promethazin* OR proazamine OR diphergan OR phenargan OR phenergan))

ProQuest (Embase, MEDLINE, Derwent drug file, Toxfile)

93

Results of the literature search studies were screened against the inclusion/exclusion criteria below:

Inclusion criteria

Study type: Clinical studies, review articles

Indication: Allergic rhinitis

Exclusion:

Study type: Nonclinical studies, case reports, letters, editorials

Indications: such as urticaria, atopic dermatitis

Studies evaluating the onset of action of antihistamines by measuring suppression of histamine-induced wheal and flare reaction in healthy subjects

Comparison with  loratadine

Two clinical studies have demonstrated cetirizine once daily to exhibit faster onset of relief than loratadine once daily in subjects with seasonal allergic rhinitis (SAR)

Day JH et al. 1998assessed reductions in total symptom complex (TSC) and the major symptom complex (MSC) scores versus placebo in patients with symptomatic SAR and demonstrated cetirizine 10 mg once daily to exhibit onset of action within 1 hour (p ≤ 0.02) when compared with 3 hours for loratadine 10 mg once daily (p ≤ 0.03).

The above finding was confirmed from another study by Day JH et al. 2001which showed onset of action again to be earlier with cetirizine 10 mg once daily (at 1 hour, p ≤ 0.001) versus loratadine 10 mg once daily (at 3 hours, p ≤ 0.01) as evaluated from reductions in MSC scores versus placebo in subjects with SAR.

Comparison with  fexofenadine

Horak F et al 20019   conducted a study comparing the efficacy and safety of cetirizine 10 mg one a day and fexofenadine 120 mg one a day in reducing symptoms of seasonal allergic rhinitis. Results of the study showed that both active medications were significantly more effective than placebo and had a comparable onset of action in alleviating the symptoms of seasonal allergic rhinitis.  This study showed  cetirizine exhibited similar onset of action when compared with fexofenadine

Comparison with other cetirizine tablets

The pharmacokinetic and pharmacodynamic data presented in the SPCs are similar between the different 10 mg cetirizine tablets 9-17. Based on the SPCs and the published literature presented above, the available one-a-day 10 mg cetirizine tablets can be considered equivalent with regard to speed of onset of action , therefore no cetirizine tablet would be reasonably expected to provide faster allergy relief than Piriteze Allergy Tablets.

Comparison with promethazine

We did not identify any clinical studies which compared the onset of action of cetirizine with promethazine in subjects with allergic rhinitis symptoms. There is no evidence to suggest promethazine may be faster

Conclusion:

Based on the evidence presented above, it is considered that the claim No one-a-day tablet provides faster hayfever relief is supportable. 

REFERENCES

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  9. Horak F, Stubner P, Zieglmayer R et al. Controlled comparison of the efficacy and safety of cetirizine 10 mg o.d. & fexofenadine 120 mg o.d. in reducing symptoms of seasonal allergic rhinitis. Int Arch Allergy Immunol 2001; 125: 73– 9.
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