Phase 2
Completed N=36
A Study to Evaluate the Effects of Indacaterol Maleate as a New Formulation in the Concept 1 Device
Source: ClinicalTrials.gov NCT01484197 ↗Enrolled (actual)
36
Serious AEs
0.8%
Results posted
Dec 2013
Primary outcomePrimary: Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment — 2.84; 2.83; 2.80; 2.64 Liters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in One Second (FEV1) After 7 Days of Treatment |
2.84; 2.83; 2.80; 2.64 | — |
| SECONDARY Trough Forced Expiratory Volume in One Second (FEV1) After 1 Day of Treatment |
2.83; 2.84; 2.81; 2.62 | — |
| SECONDARY Peak FEV1 at Day 1 and Day 7 |
3.08; 3.11; 3.05; 2.85; 3.09; 3.11 | — |
| SECONDARY Time to Peak FEV1 at Day 1 and Day 7 |
3.98; 3.02; 3.00; 3.00; 3.00; 3.05 | — |
| SECONDARY FEV1 at Each Time-Point on Day 1 and Day 2 |
2.61; 2.65; 2.68; 2.67; 2.85; 2.97 | — |
| SECONDARY FEV1 at Each Time-Point on Day 7 and Day 8 |
2.80; 2.79; 2.85; 2.63; 2.87; 2.88 | — |
| SECONDARY Forced Vital Capacity (FVC) at Each Time-Point on Day 1 and Day 2 |
4.11; 4.30; 4.23; 4.27; 4.29; 4.52 | — |
| SECONDARY Forced Vital Capacity (FVC) at Each Time-Point on Day 7 and Day 8 |
4.28; 4.30; 4.35; 4.22; 4.34; 4.33 | — |
| SECONDARY FEV1/FVC at Each Post-Dose Time Point on Day 1 and Day 2 |
0.63; 0.62; 0.64; 0.63; 0.67; 0.66 | — |
| SECONDARY FEV1/FVC at Each Post-dose Time Point on Day 7 and Day 8 |
0.65; 0.65; 0.65; 0.62; 0.66; 0.66 | — |
| SECONDARY Forced Expiratory Flow 25- 75% (FEF25-75) on Day 1 and Day 2 |
1.55; 1.52; 1.54; 1.56; 1.78; 1.81 | — |
| SECONDARY Forced Expiratory Flow 25- 75% (FEF25-75) on Day 7 and Day 8 |
1.70; 1.69; 1.71; 1.51; 1.76; 1.78 | — |
| SECONDARY Standardized FEV1 AUC Between Baseline (Pre-dose) and 4 Hour Post-dose (AUC0-4h) |
2.94; 3.00; 2.94; 2.72; 2.96; 2.98 | — |
| SECONDARY Standardized FEV1 AUC Between Baseline (Pre-dose) and 12 Hour Post-dose (AUC0-12h) |
2.90; 2.94; 2.87; 2.68; 2.93; 2.92 | — |
| SECONDARY Peak Expiratory Flow Rate in the Morning in the Evening |
451.33; 447.15; 444.11; 421.58; 474.09; 464.39 | — |
| SECONDARY Number of Puffs of Rescue Medicine |
1.98; 1.90; 1.91; 1.94 | — |
| SECONDARY Number of Participants With Adverse Events as a Measure of Safety |
14; 16; 17; 10 | — |
| SECONDARY Time to Reach Maximum Concentration (Tmax) After Drug Administration |
0.27; 0.48; 0.48; 0.25; 0.48; 0.25 | — |
| SECONDARY Observed Maximum Concentration (Cmax) After Drug Administration |
72.9; 124; 64.2; 112; 174; 90.5 | — |
| SECONDARY Area Under the Curve Pre-dose to 24 Hour Post Dose (AUC0-24h) |
501; 802; 451; 1110; 1770; 952 | — |
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
Data sourced from ClinicalTrials.gov (NCT01484197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.