Back to results

A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps

Primary Purpose

Nasal Polyps

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Intranasal Beclomethasone aerosol

Intranasal Beclomethasone spray

About this trial

This is an interventional treatment trial for Nasal Polyps focused on measuring administration, intranasal, aerosol, beclomethasone, QVAR, corticosteroids, nasal polyps, rhinomanometry, Rhinitis Quality of Life Questionnaire, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Allergy Clinic, London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aerosol

Spray

Arm Description

Outcomes

Primary Outcome Measures

Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire

Secondary Outcome Measures

Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry

Full Information

NCT ID

NCT00788463

First Posted

November 7, 2008

Last Updated

August 25, 2017

Sponsor

Lawson Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00788463

Brief Title

A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps

Official Title

A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Completed

Study Start Date

November 23, 2006 (Actual)

Primary Completion Date

March 30, 2009 (Actual)

Study Completion Date

November 30, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lawson Health Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasal Polyps

Keywords

administration, intranasal, aerosol, beclomethasone, QVAR, corticosteroids, nasal polyps, rhinomanometry, Rhinitis Quality of Life Questionnaire, Quality of Life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aerosol

Arm Type

Experimental

Arm Title

Spray

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Intranasal Beclomethasone aerosol

Other Intervention Name(s)

QVAR

Intervention Description

Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.

Intervention Type

Drug

Intervention Name(s)

Intranasal Beclomethasone spray

Intervention Description

Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.

Primary Outcome Measure Information:

Title

Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire

Time Frame

0, 1, 3, 6 months

Secondary Outcome Measure Information:

Title

Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry

Time Frame

0, 1, 3, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge A Mazza, MD

Organizational Affiliation

Western University, Canada

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allergy Clinic, London Health Sciences Centre

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4G5

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

13196789

Citation

SILCOX LE. The intranasal use of hydrocortisone alcohol. AMA Arch Otolaryngol. 1954 Oct;60(4):431-9. doi: 10.1001/archotol.1954.00720010443005. No abstract available.

Results Reference

background

PubMed Identifier

14308145

Citation

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.

Results Reference

background

PubMed Identifier

4891434

Citation

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.

Results Reference

background

PubMed Identifier

5230040

Citation

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. doi: 10.1016/0021-8707(67)90060-3. No abstract available.

Results Reference

background

PubMed Identifier

4800886

Citation

Mygind N, Hansen I. Beclomethasone dipropionate aerosol effect on the adrenals in normal persons. Acta Allergol. 1973 Sep;28(3):211-8. doi: 10.1111/j.1398-9995.1973.tb01327.x. No abstract available.

Results Reference

background

PubMed Identifier

1095246

Citation

Mygind N, Pedersen CB, Prytz S, Sorensen H. Treatment of nasal polyps with intranasal beclomethasone dipropionate aerosol. Clin Allergy. 1975 Jun;5(2):159-64. doi: 10.1111/j.1365-2222.1975.tb01848.x.

Results Reference

background

PubMed Identifier

790892

Citation

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. doi: 10.3109/00016487609120899.

Results Reference

background

PubMed Identifier

790891

Citation

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. doi: 10.3109/00016487609120898.

Results Reference

background

PubMed Identifier

665215

Citation

Mygind N, Sorensen 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.

Results Reference

background

PubMed Identifier

7116616

Citation

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. doi: 10.1111/j.1365-2222.1982.tb02544.x.

Results Reference

background

PubMed Identifier

6344703

Citation

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

Results Reference

background

PubMed Identifier

7499945

Citation

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. doi: 10.1017/s002221510013172x.

Results Reference

background

PubMed Identifier

10077256

Citation

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. doi: 10.1016/s0385-8146(98)00062-5.

Results Reference

background

PubMed Identifier

10837586

Citation

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. doi: 10.1016/s0169-409x(97)00067-7.

Results Reference

background

PubMed Identifier

6379630

Citation

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. doi: 10.1136/pgmj.60.704.404.

Results Reference

background

PubMed Identifier

6667629

Citation

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. doi: 10.1185/03007998309109815.

Results Reference

background

PubMed Identifier

6374683

Citation

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.

Results Reference

background

Learn more about this trial

A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps

We'll reach out to this number within 24 hrs