Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boston Scientific Corporation
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject is an adult between the ages of 18 to 65 years.
Subject has asthma and is taking regular maintenance medication that includes Inhaled corticosteroid (ICS) AND long acting ß2-agonist (LABA).
Subject has a Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
Subject has a PC20 \< 8 mg/ml per methacholine inhalation test using standardized methods. PC20 is a provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline.
Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period.
Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
You may not be if
Subject has a Post-bronchodilator FEV1 of less than 65%.
Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; OR a history of life-threatening asthma, defined by past intubations for asthma, or ICU admission for asthma within the prior 24 months.
Subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
Subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
Subject has known systemic hypersensitivity or contraindication to Methacholine chloride or other parasympathomimetic agents.
