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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004095-37-SK

Enrollment

100

Registered

2004-12-15

Start date

2005-02-25

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1) Stable persistent asthma 2) COPD

Interventions

Product Name: QAB149 Multi-dose Dry Powder Inhaler (MDDPI) Product Code: QAB149 Pharmaceutical Form: Inhalation powder INN or Proposed INN: Indacaterol CAS Number: 435273-74-8 Current Sponsor code: QA

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Patients not having experienced cough in previous QAB149 studies

Design outcomes

Primary

Measure	Time frame
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 b) To better explore the nature, duration and severity of any cough c) To explore the incidence of cough in patients taking QAB149 versus salmeterol d) To explore the bronchodilatory measures of QAB149 e) To explore the safety and tolerability of QAB149. ;Primary end point(s): None. FEV1 will be measured for safety purposes	—

Measure

Time frame

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 b) To better explore the nature, duration and severity of any cough c) To explore the incidence of cough in patients taking QAB149 versus salmeterol d) To explore the bronchodilatory measures of QAB149 e) To explore the safety and tolerability of QAB149. ;Primary end point(s): None. FEV1 will be measured for safety purposes

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Countries

Belgium, Germany, Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026