Verification Information.

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.

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

Table 2 – Maximum OTC doses of Identified Active Ingredients

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.

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.⁵  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^§

* 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

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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
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6. Pirinase Allergy 0.05% Nasal Spray Patient Information Leaflet
   https://www.medicines.org.uk/emc/files/pil.4502.pdf Accessed July 2020
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   https://www.medicines.org.uk/emc/files/pil.5116.pdf Accessed July 2020
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    https://www.medicinescomplete.com/#/content/martindale/6100-a5-9-p accessed July 2020
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Table 1 - Active ingredients available OTC in tablet form for the relief of allergy symptoms