Detection of airway hyperresponsiveness in patients with asthma or COPD MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Aridol
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: MANNITOL
CAS Number: 69658
Product Name: Methacholine
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Asthmatics: - Episodic symptoms of dyspnea, and/or wheezing, and/or cough - Allergic or non-allergic - PC20 MCh 40 yrs - Active or former smokers, with a smoking history of more than 10 packyears - Continuous symptoms of cough/sputum and/or dyspnea on exertion - No history of asthma - FEV1/FVC 8 mg/mL. - FEV1/FVC > 70 % and FEV1 > 80 %pred Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age 200, or diastolic BP > 100 - Known aortic aneurysm - Pregnancy - Nursing mothers - Current use of cholinesterase inhibitor medication (for myasthenia gravis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To test feasibility of mannitol inhalations in a Dutch pulmonary out-patient clinic. 2. To compare time and costs involved in measuring airways hyperresponsiveness by methacholine to mannitol;Secondary Objective: ;Primary end point(s): - Time involved in measurement of hyperresponsiveness (including technician time for preparation and cleaning) | — |
Countries
Netherlands
Outcome results
None listed