An exploratory, multi-center, randomized, open-label, single dose, crossover study to assess the safety and tolerability of 200µg of QAB149, delivered via a MDDPI, with or without the co-administration of water, with inhalation of 50µg of salmeterol, via a MDDPI, as an active comparator, in adult and adolescent patients with stable persistent asthma, or patients with COPD. - Not applicable

Phase 1

• Conditions: 1) Stable persistent asthma2) COPD

• Registration Number: EUCTR2004-004095-37-SK
• Lead Sponsor: ovartis Pharma Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-12-15
• Study Completion: 2005-04-30
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1) Male and female adult and adolescent patients who, when on a dose of QAB149, have experienced cough in either studies A2208, A2210, A2216, A2218, B2201 or B2205, and who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to asthma/COPD medication prior to Visit 1.
2) In the case of patients below the legal age of consent, the Informed Consent Form should also be signed by the patient’s parent / guardian.
3) COPD patients must have an FEV1 > 1 liter at Visit 1.

Are the trial subjects under 18? yes
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

Patients not having experienced cough in previous QAB149 studies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore whether the co-administration of a glass of water, either immediately prior to or immediately after the inhalation of QAB149 compared with the inhalation of QAB149 without co-administration of water has any influence upon the incidence of cough.;Secondary Objective: a) To explore the extent to which the re-challenge of QAB149 results in cough in patients reporting cough from previous trials<br>b) To better explore the nature, duration and severity of any cough<br>c) To explore the incidence of cough in patients taking QAB149 versus salmeterol<br>d) To explore the bronchodilatory measures of QAB149<br>e) To explore the safety and tolerability of QAB149.<br>;Primary end point(s): None. FEV1 will be measured for safety purposes