A study to evaluate the effects of indacaterol maleate as a new formulation in the EPIC test fixture.

A randomized, double-blind, double-dummy, placebo-controlled, 3-period crossover study to evaluate the pharmacodynamics, pharmacokinetics, safety and tolerability of orally inhaled indacaterol administered via the EPIC test fixture and the Concept1 device in adult patients with persistent asthma.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001824-39-GB

Enrollment

Registered

2013-04-11

Start date

2013-05-08

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

Persistent Asthma MedDRA version: 14.1 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: QAB149 75mcg Product Code: QAB149 Pharmaceutical Form: Inhalation powder, hard capsule Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male and female patients with asthma, aged 18 or above - Patients using inhaled corticosteroid (with or without long acting beta agonist) - Patients who demonstrate an increase in FEV1 after inhaling a short acting beta agonist - Other protocol-defined inclusion criteria apply. 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 39 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: - Asthma exacerbations in previous 6 months COPD or other pulmonary disease - Excessive use of short acting beta agonists Other protocol-defined exclusion criteria apply.

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Trough Forced Expiratory Volume in 1 Second (FEV1) Following 3 Days of Treatment Outcome Measure Description: FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 10min and 23h 45min post the Day 3 dose.;Timepoint(s) of evaluation of this end point: Day 4;Main Objective: To assess the bronchodilator effect of once-daily lactose-blended (LB) indacaterol administered via the EPIC test fixture and Concept1 in adult patients with persistent asthma compared with placebo as measured by trough FEV1 after 3 days of treatment.;Secondary Objective: Assess the bronchodilator effect of once-daily indacaterol via EPIC test fixture and Concept1 in patients with asthma compared with placebo as measured by: - trough FEV1 after 1 day of treatment. - Peak and time to peak FEV1 on Days 1 and 3. - FEV1, Forced Vital Capacity (FVC), FEV1/FVC and forced expiratory flow 25–75% (FEF25-75%) at each post-dose time point. - Standardized FEV1 AUC between baseline (pre-dose) and 4 h postdose (AUC0-4h) on Days 1 and 3 of treatment. - Peak expiratory flow rate (PEFR) - Rescue medication use over the course of the treatment. - Assessment of safety and tolerability - Assessment of pharmacokinetics	—

Measure

Time frame

Primary end point(s): Trough Forced Expiratory Volume in 1 Second (FEV1) Following 3 Days of Treatment Outcome Measure Description: FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. The trough in FEV1 was defined as the mean of two measurements at 23h 10min and 23h 45min post the Day 3 dose.;Timepoint(s) of evaluation of this end point: Day 4;Main Objective: To assess the bronchodilator effect of once-daily lactose-blended (LB) indacaterol administered via the EPIC test fixture and Concept1 in adult patients with persistent asthma compared with placebo as measured by trough FEV1 after 3 days of treatment.;Secondary Objective: Assess the bronchodilator effect of once-daily indacaterol via EPIC test fixture and Concept1 in patients with asthma compared with placebo as measured by: - trough FEV1 after 1 day of treatment. - Peak and time to peak FEV1 on Days 1 and 3. - FEV1, Forced Vital Capacity (FVC), FEV1/FVC and forced expiratory flow 25–75% (FEF25-75%) at each post-dose time point. - Standardized FEV1 AUC between baseline (pre-dose) and 4 h postdose (AUC0-4h) on Days 1 and 3 of treatment. - Peak expiratory flow rate (PEFR) - Rescue medication use over the course of the treatment. - Assessment of safety and tolerability - Assessment of pharmacokinetics

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3 2. Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3 3. Forced Vital Capacity (FVC) at Each Time-point on Day 1, 2, 3 and 4 4. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From pre-dose to 4 hours post dose on Days 1 and 3 5. Peak Expiratory Flow Rate measured daily each morning and evening. 6. Forced Expiratory Volume in 1 Second (FEV1) 7. Ratio of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) (FEV1/FVC ) 8. Forced expiratory Flow 25-75% (FEF25-75%) 9. Number of puffs of rescue medication used 10. The number of participants with adverse events used as a measure of Safety and Tolerability 11. AUC (0-24) - area under the serum concentration-time curve 12. Cmax - observed maximum serum concentration following drug administration 13. Tmax - time to reach maximum concentration after drug administration 14. Racc - accumulation ratio of exposure (AUC0-24 and Cmax) on Day 3 relative to Day 1 15. Trough Forced Expiratory Volume in 1 Second (FEV1) Following 1 Day of Treatment ;Timepoint(s) of evaluation of this end point: 1. Day 1 and 3 2. Day 1 and 3 3. Day 1, 2, 3 and 4 4. Day 1 and 3 5. Morning and evening from screening to study completion (up to 86 days) 6. Days 1, 2, 3 and 4 7. Days 1, 2, 3 and 4 8. Days 1, 2, 3 and 4 9. Everyday from screening to study completion (up to 86 days) 10. Baseline to study completion (up to 59 days) 11. Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose 12. Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose 13. Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose 14. Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose 15. Day 2	—

Measure

Time frame

Secondary end point(s): 1. Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3 2. Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Days 1 and 3 3. Forced Vital Capacity (FVC) at Each Time-point on Day 1, 2, 3 and 4 4. Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From pre-dose to 4 hours post dose on Days 1 and 3 5. Peak Expiratory Flow Rate measured daily each morning and evening. 6. Forced Expiratory Volume in 1 Second (FEV1) 7. Ratio of Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) (FEV1/FVC ) 8. Forced expiratory Flow 25-75% (FEF25-75%) 9. Number of puffs of rescue medication used 10. The number of participants with adverse events used as a measure of Safety and Tolerability 11. AUC (0-24) - area under the serum concentration-time curve 12. Cmax - observed maximum serum concentration following drug administration 13. Tmax - time to reach maximum concentration after drug administration 14. Racc - accumulation ratio of exposure (AUC0-24 and Cmax) on Day 3 relative to Day 1 15. Trough Forced Expiratory Volume in 1 Second (FEV1) Following 1 Day of Treatment ;Timepoint(s) of evaluation of this end point: 1. Day 1 and 3 2. Day 1 and 3 3. Day 1, 2, 3 and 4 4. Day 1 and 3 5. Morning and evening from screening to study completion (up to 86 days) 6. Days 1, 2, 3 and 4 7. Days 1, 2, 3 and 4 8. Days 1, 2, 3 and 4 9. Everyday from screening to study completion (up to 86 days) 10. Baseline to study completion (up to 59 days) 11. Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose 12. Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose 13. Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose 14. Day 1 and Day 3 (pre-dose, 5, 15, 30 mins, 1, 2, 4, 8, 12, 24hours post dose 15. Day 2

—

Countries

United Kingdom

Contacts

Public ContactMedical Information Services

Novartis Pharmaceuticals UK Ltd

medinfo.uk@novartis.com+441276698370

Outcome results

None listed

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