A Multi-centre, Randomized, Double-blind, Double-dummy, Multiple-dose, Crossover Study to Evaluate the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Orally Inhaled Indacaterol Administered as Either PulmoSphere or Lactose-blend Powder Via the Concept1 Device in Adult Patients With Persistent Asthma
Overview
- Phase
- Phase 2
- Intervention
- 75 µg indacaterol maleate (LB)
- Conditions
- Asthma
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This study will assess the pharmacodynamics, safety, tolerability and pharmacokinetics of two different formulations of indacaterol maleate, both administered via the Concept1 device. The study aims to determine whether the novel formulation has a similar clinical profile as the established formulation.
Investigators
Eligibility 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
Exclusion Criteria
- •Asthma exacerbations in previous 6 months
- •COPD or other pulmonary disease
- •Excessive use of short acting beta agonists
Arms & Interventions
75 µg Indacaterol (LB) + Placebo (PoS)
75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
Intervention: 75 µg indacaterol maleate (LB)
75 µg Indacaterol (LB) + Placebo (PoS)
75 µg indacaterol maleate lactose blend (LB) + placebo to indacterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
Intervention: placebo to indacaterol (PoS)
75 µg Indacaterol (PoS) + Placebo (LB)
75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
Intervention: 75 µg indacaterol maleate (PoS)
75 µg Indacaterol (PoS) + Placebo (LB)
75 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
Intervention: placebo to indacaterol (LB)
37.5 µg Indacaterol (PoS) + Placebo (LB)
37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
Intervention: 37.5 µg indacaterol maleate (PoS)
37.5 µg Indacaterol (PoS) + Placebo (LB)
37.5 µg indacaterol maleate PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
Intervention: placebo to indacaterol (LB)
Placebo (LB) and Placebo (PoS)
Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
Intervention: placebo to indacaterol (LB)
Placebo (LB) and Placebo (PoS)
Placebo to indacaterol PulmoSphereTM (PoS) + placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
Intervention: placebo to indacaterol (PoS)
Outcomes
Primary Outcomes
Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment
Time Frame: Day 8
Spirometry was performed according to internationally accepted standards at Day 8. Trough FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Trough FEV1 was defined as the average of the FEV1 measurements at 23 hours 10 minutes and 23 hours 45 minutes post dose.at Day 8. Analysis of Covariance with treatment, period, sequence and subject nested within sequence as fixed effects and period FEV1 baseline as a covariate.
Secondary Outcomes
- Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment(Day 2)
- Number of Participants With Adverse Events as a Measure of Safety(Up to 101 days)
- Peak FEV1 at Day 1 and Day 7(Day 1, Day 7)
- Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8(Day 7, Day 8)
- Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2(Day 1, Day 2)
- Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h)(Day 1, Day 7)
- Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2(Day 1, Day 2)
- FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2(Day1, Day 2)
- Number of Puffs of Rescue Medicine(Up to 101 days)
- Time to Peak FEV1 at Day 1 and Day 7(Day 1, Day 7)
- FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8(Day 7, Day 8)
- Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8(Day 7, Day 8)
- Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h)(Day 1, Day 7)
- Observed Maximum Concentration (Cmax) After Drug Administration(Day 1, Day 7)
- Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h)(Day 1, Day 7)
- FEV1 at Each Time-Point on Day 1 and Day 2(Day 1, Day 2)
- FEV1 at Each Time-Point on Day 7 and Day 8(Day 7, Day 8)
- Peak Expiratory Flow Rate in the Morning in the Evening(Up to 101 days)
- Time to Reach Maximum Concentration (Tmax) After Drug Administration(Day1, Day 7)