The Effect of Deep Inhalation on Mannitol Responsiveness
キーワード
概要
説明
This study will look at airway responsiveness to inhaled methacholine and mannitol administered with and without deep inhalation. This study will also investigate the role of airway inflammation on these responses, using sputum differential cell counts and fractional exhaled nitric oxide.
This is a single center, open label, randomized study. Individuals with stable asthma will be eligible for enrollment. The study will consist of two parts, screening and testing.
Part 1: Screening
Participants will undergo consent procedures and assessments of fractional exhaled nitric oxide levels, airway responsiveness to methacholine and sputum induction. If participants show airway responsiveness to methacholine (i.e. methacholine PC20 16mg/mL), they will be scheduled to undergo the testing part of the study.
Part 2: Testing
Participants will be randomized to undergo two methacholine or two mannitol challenges. Further randomization will occur with respect to whether the standard challenge method or the modified challenge method is performed first.
日付
| 最終確認済み: | 04/30/2019 |
| 最初に提出された: | 03/28/2018 |
| 提出された推定登録数: | 04/19/2018 |
| 最初の投稿: | 04/22/2018 |
| 最終更新が送信されました: | 05/13/2019 |
| 最終更新日: | 05/14/2019 |
| 実際の研究開始日: | 05/31/2018 |
| 一次完了予定日: | 04/29/2019 |
| 研究完了予定日: | 04/29/2019 |
状態または病気
介入/治療
Procedure: Deep inhalation technique
Procedure: Tidal breathing technique
Drug: Methacholine
Drug: Mannitol
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Mannitol challenge Mannitol challenge performed per standard mannitol challenge procedure with deep inhalation technique | |
| Experimental: Mannitol challenge w/ TBI Mannitol challenge performed per standard mannitol challenge procedure except with tidal breathing technique | |
| Experimental: Methacholine challenge w/ DI Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure except with deep inhalation technique | |
| Experimental: Methacholine challenge Methacholine challenge performed per standard 2-minute tidal breathing challenge procedure (tidal breathing technique) |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - signed informed consent - men and women between 18 and 75 years of age - FEV1 at first measurement of greater than or equal to 65% predicted - methacholine provocative concentration causing a 20% in FEV1 at screening that is less than or equal to 16mg/ml - generally good health - stable asthma Exclusion Criteria: - respiratory infection within 4 weeks of screening visit - worsening of asthma within 4 weeks of screening visit - lung disease other than asthma - significant medical comorbidity - current smoker or ex-smoker with significant smoking history - currently pregnant or breastfeeding |
結果
主な結果の測定
1. Effect of deep inhalation (versus tidal breathing) on mannitol provocative dose causing a 15% fall in forced expiratory volume in one second (FEV1) [24 hours between mannitol challenges]
二次的な結果の測定
1. Effect of airway inflammation on methacholine and mannitol challenge results-fractional exhaled nitric oxide [up to 2 weeks, from baseline to end of study]
2. Effect of airway inflammation on methacholine and mannitol challenge results-sputum [up to 2 weeks, from baseline to end of study]
3. Effect of deep inhalation (versus tidal breathing) on methacholine provocative [24 hours between methacholine challenges]
