A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps - Full Text View

Sponsored by:	Lawson Health Research Institute
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00788463

Purpose

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

Condition	Intervention	Phase
Nasal Polyps	Drug: Intranasal Beclomethasone aerosol Drug: Intranasal Beclomethasone spray	Phase II

Drug Information available for: Corticosteroids Beclomethasone dipropionate Beclomethasone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire [ Time Frame: 0, 1, 3, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry [ Time Frame: 0, 1, 3, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Aerosol: Experimental	Drug: Intranasal Beclomethasone aerosol Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.
Spray: Active Comparator	Drug: Intranasal Beclomethasone spray Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788463

Contacts

Contact: Jorge A Mazza, MD

519-685-8500 ext 58277

jmazza@uwo.ca

Locations

Canada, Ontario
Allergy Clinic, London Health Sciences Centre	Recruiting
London, Ontario, Canada, N6A 4G5

Sponsors and Collaborators

Lawson Health Research Institute

Investigators

Principal Investigator:

Jorge A Mazza, MD

University of Western Ontario, Canada

More Information

Publications:

SILCOX LE. The intranasal use of hydrocortisone alcohol. AMA Arch Otolaryngol. 1954 Oct;60(4):431-9. No abstract available.

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.

Mygind N, Hansen I. Beclomethasone dipropionate aerosol effect on the adrenals in normal persons. Acta Allergol. 1973 Sep;28(3):211-8. No abstract available.

Mygind N, Pedersen CB, Prytz S, Sørensen H. Treatment of nasal polyps with intranasal beclomethasone dipropionate aerosol. Clin Allergy. 1975 Jun;5(2):159-64.

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.

Responsible Party:	London Health Sciences Centre ( Jorge Mazza )
Study ID Numbers:	R-06-542, 12801
Study First Received:	November 7, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00788463
Health Authority:	Canada: Health Canada

Keywords provided by Lawson Health Research Institute:

administration, intranasal
aerosol
beclomethasone
QVAR
corticosteroids

nasal polyps
rhinomanometry
Rhinitis Quality of Life Questionnaire
Quality of Life

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Nasal Polyps
Otorhinolaryngologic Diseases
Beclomethasone

Quality of Life
Polyps
Rhinitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009