Phase 3
Completed N=415
Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT00677807 ↗Enrolled (actual)
415
Serious AEs
11.1%
Results posted
Aug 2011
Primary outcomePrimary: The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo — 3; 3; 2; 0 Participants
Summary
This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo |
3; 3; 2; 0; 1; 0 | — |
| PRIMARY The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo |
2; 2; 2; 1; 2; 2 | — |
| PRIMARY The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo |
6; 3; 2; 1; 0; 2 | — |
| PRIMARY The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment With Indacaterol 150 µg or 300 µg Compared to Placebo |
10; 9; 11; 28; 30; 30 | — |
| PRIMARY Serum Potassium (mmol/L) 1 Hour Post-dose at Weeks 12, 26, 36, 44 and 52 |
4.45; 4.50; 4.45; 4.53; 4.53; 4.55 | — |
| PRIMARY Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 12, 26, 36, 44 and 52 |
5.50; 5.59; 5.18; 5.93; 5.77; 5.49 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 52 of Treatment |
1.44; 1.45; 1.27 | — |
| SECONDARY Quality of Life Assessment With St George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 36, 44 and 52 |
36.62; 36.37; 39.56; 35.98; 36.18; 41.67 | — |
Eligibility Criteria
Inclusion Criteria
- Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).
- In addition the following inclusion/exclusion criteria specified below must be met.
- Patients must complete Stage 2 of the core study B2335S (NCT00463567).
- Written informed consent to participate in the extension must be obtained.
- Patients must be able to comply with all study requirements.
Exclusion Criteria
- Patients who were randomized to open-label tiotropium in Study B2335S.
- Patients who participated in Stage 1 of the core study (B2335S).
- Patients discontinued irrespective of the reason from Stage 2 of the core study.
- Patients who fail to comply with the core protocol requirements and procedures.
- Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
- Patients who in the Investigator's opinion should not participate in the extension study.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00677807). 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.