mild asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Trade Name: Spiriva
Product Name: Spiriva
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: TIOTROPIUM BROMIDE
CAS Number: 139404481
Concentration unit: µg microgram(s)
Concent
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - All patients must sign and date an Informed Consent Form for the study consistent with ICH-GCP guidelines and local legislation prior to participation in the trial - Male or female with at least 18 years of age - Patients must have a documented history of asthma (at least 6 months) - Patients must be current non-smokers or ex-smokers with a cigarette smoking history of = 10 pack-years (and smoking cessation et least one year prior to study enrolment) Pack years= (Number of cigarettes/day)/20 x years of smoking - Patients must be able to perform technically acceptable pulmonary, methacholine and neurokinin A (NKA) challenge tests - At Visit 1: PC20 methacholine = 8 mg/mL AND = 3.3x10-7 mol/mL for the NKA challenge test - At Visit1: FEV1 predicted = 70% - Females must be of non-childbearing potential OR taking adequate contraceptive precautions AND not be a nursing mother 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: - Any respiratory tract infection or asthma exacerbation within 6 weeks of Visit1 - Respiratory diseases other than asthma (COPD, bronchiectasis, lung cancer, mesothelioma, cystic fibrosis, active tuberculosis) - Currently participation in another clinical study - Relevant concomitant systemic diseases other than asthma (malignancy, unstable cardial disease, moderate to severe renal impairment [creatinine clearance = 50 mL/min]) - Clinically significant laboratory abnormalities - Alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of 20 days 18 µg tiotropium bromide once daily on the airway responsiveness to neurokinin A in patients with mild asthma, in order to study the real contribution of the cholinergic activation by NKA, by an agent that is relatively selective for M3. ;Secondary Objective: ;Primary end point(s): The mean change in the provocative concentration of NKA causing a 20% fall of FEV1 (PC20 NKA), as a measure of indirect airway hyperresponsiveness, following 20 days of treatment with tiotropium. | — |
Countries
Belgium
Outcome results
None listed