Phase 4
Completed N=221
Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT02683109 ↗
Enrolled (actual)
221
Serious AEs
1.4%
Results posted
Aug 2018
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment — 1.422; 1.399 Liter — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.
Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment |
1.422; 1.399 | <0.0001 sig |
| SECONDARY Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment |
3.126; 3.121 | 0.8648 |
| SECONDARY Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28 |
15.423; 15.750 | 0.5420 |
Eligibility Criteria
Inclusion criteria
- Male or female patients.
- Patients 40 years of age or older.
- Patients with a smoking history > 10 pack years.
- Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) >= 30% and = 10 at screening.
- Further inclusion criteria apply.
Exclusion criteria
- COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
- Patients with a current diagnosis of asthma.
- Further exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT02683109). 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.