- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00788463
A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
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Ontario
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London, Ontario, 캐나다, N6A 4G5
- Allergy Clinic, London Health Sciences Centre
-
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Aerosol
|
Beclomethasone aerosol intranasal, 100ug each nostril, twice daily for 6 months.
다른 이름들:
|
활성 비교기: Spray
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Beclomethasone spray intranasal, 100ug each nostril, twice daily for 6 months.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Difference in overall quality of life as measured by the Rhinitis Quality of Life Questionnaire
기간: 0, 1, 3, 6 months
|
0, 1, 3, 6 months
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Difference in Nasal Airflow Resistance as measured an anterior rhinomanometry
기간: 0, 1, 3, 6 months
|
0, 1, 3, 6 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jorge A Mazza, MD, Western University, Canada
간행물 및 유용한 링크
일반 간행물
- 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.
- 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. doi: 10.1016/0021-8707(67)90060-3. 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. doi: 10.1111/j.1398-9995.1973.tb01327.x. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. doi: 10.1017/s002221510013172x.
- 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.
- 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.
- 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.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- R-06-542
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