Brief Summary

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Official Title: "A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps"

The purpose of this study is to determine if intranasal Beclomethasone delivered by aerosol or spray is more effective in treatment of nasal polyps.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Study Primary Completion Date: March 2009

Detailed Clinical Trial Description

Aqueous and aerosol delivery of intranasal corticosteroids has never been directly compared previously in patients with nasal polyps and it is unknown whether one is superior.

This objective of this study is to compare the efficacy of intranasal beclomethasone by two different delivery systems, aerosol and aqueous spray in patients with nasal polyps. Primary endpoint is the difference in the overall quality of life as measured by the Rhinitis Quality of Life Questionnaire. The secondary endpoint is the change in Nasal Airflow Resistance as measured by rhinomanometry.

Interventions Used in this Clinical Trial

• Drug: Intranasal Beclomethasone aerosol
  • Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.
• Drug: Intranasal Beclomethasone spray
  • Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Aerosol
• Active Comparator: Spray

Outcome Measures for this Clinical Trial

Primary Measures

• Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire
  • Time Frame: 0, 1, 3, 6 months
    Safety Issue?: No

Secondary Measures

• Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry
  • Time Frame: 0, 1, 3, 6 months
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• 18 years old
• New diagnosis of nasal polyps confirmed by two physicians

Exclusion Criteria

• Intranasal corticosteroid use within 4 weeks
• Oral corticosteroids use within 4 weeks
• Oral corticosteroid inhalation (ie for treatment of asthma or COPD) of Budesonide >400ug daily, Fluticasone >250ug daily, Beclomethasone >400ug daily
• Contraindication to intranasal corticosteroid
• Inability to give informed consent
• Participation in another clinical trial
• Pregnancy (or not using effective method of contraception) or lactation
• Cystic fibrosis

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Lawson Health Research Institute
• Provider of Information About this Clinical Study
  • Jorge Mazza, London Health Sciences Centre
• Overall Official(s)
  • Jorge A Mazza, MD, Principal Investigator, University of Western Ontario, Canada
• Overall Contact(s)
  • Jorge A Mazza, MD, 519-685-8500, jmazza@uwo.ca

References

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SMITH RE. DEXAMETHASONE NASAL AEROSOL IN NASAL POLYPS AND HYPERTROPHIC ALLERGIC RHINITIS: A CLINICAL AND CONTROLLED EVALUATION. Ann Allergy. 1965 Jun;23:273-6. No abstract available.

Taub SJ. Dexamethasone nasal aerosol vs. placebo in the treatment of nasal polyposis. Eye Ear Nose Throat Mon. 1968 Aug;47(8):392-5. No abstract available.

Norman PS, Winkenwerder WL, Agbayani BF, Migeon CJ. Adrenal function during the use of dexamethasone aerosols in the treatment of ragweed hay fever. J Allergy. 1967 Jul;40(1):57-61. No abstract available.

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Sorensen H, Mygind N, Pedersen CB, Prytz S. [Long-term treatment of nasal polyps with beclomethasone dipropionate aerosol. III. Morphological studies and conclusions.] Acta Otolaryngol. 1976 Sep-Oct;82(3-4):260-2.

Pedersen CB, Mygind N, Sorensen H, Prytz S. Long-term treatment of nasal polyps with beclomethasone dipropionate aerosol. II. Clinical results. Acta Otolaryngol. 1976 Sep-Oct;82(3-4):256-9.

Mygind N, Sørensen H, Pedersen CB. The nasal mucosa during long-term treatment with beclomethasone dipropionate aerosol. A light-and scanning electron microscopic study of nasal polyps. Acta Otolaryngol. 1978 May-Jun;85(5-6):437-43.

Toft A, Wihl JA, Toxman J, Mygind N. Double-blind comparison between beclomethasone dipropionate as aerosol and as powder in patients with nasal polyposis. Clin Allergy. 1982 Jul;12(4):391-401.

Krouse HA, Phung ND, Klaustermeyer WB. Intranasal beclomethasone in severe rhinosinusitis and nasal polyps. Ann Allergy. 1983 Jun;50(6):385-8.

el Naggar M, Kale S, Aldren C, Martin F. Effect of Beconase nasal spray on olfactory function in post-nasal polypectomy patients: a prospective controlled trial. J Laryngol Otol. 1995 Oct;109(10):941-4.

Irifune M, Ogino S, Harada T, Abe Y. Topical treatment of nasal polyps with a beclomethasone dipropionate powder preparation. Auris Nasus Larynx. 1999 Jan;26(1):49-55.

Vidgren MT, Kublik H. Nasal delivery systems and their effect on deposition and absorption. Adv Drug Deliv Rev. 1998 Jan 5;29(1-2):157-177.

Dunn AM, Wilson RS, Baggott PJ. A comparison of beclomethasone dipropionate aqueous nasal spray and beclomethasone dipropionate pressurized nasal spray in the management of seasonal rhinitis. Postgrad Med J. 1984 Jun;60(704):404-6.

Sidwell S. A comparison of the efficacy and tolerance of an aqueous beclomethasone dipropionate nasal spray with the conventional pressurized spray. Curr Med Res Opin. 1983;8(9):659-64.

Harries MG, Anderson PB, Gibson GJ, Hof ZE, Baggott PJ. A comparison of an aqueous and a pressurized nasal spray of beclomethasone dipropionate in the management of seasonal rhinitis. Pharmatherapeutica. 1984;3(9):623-5.