Phase 3
Completed N=219
Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01559116 ↗
Enrolled (actual)
219
Serious AEs
3.0%
Results posted
Jul 2015
Primary outcomePrimary: Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment. — -0.037; 0.129; 0.117; 0.133 Litres (L) — p=<0.0001
Summary
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment. |
-0.037; 0.129; 0.117; 0.133; 0.241; 0.244 | <0.0001 sig |
| SECONDARY FEV1 AUC0-12h Response [L] After 6 Weeks Treatment. |
-0.013; 0.179; 0.171; 0.186; 0.310; 0.305 | <0.0001 sig |
| SECONDARY FEV1 AUC12-24h Response [L] After 6 Weeks Treatment. |
-0.060; 0.079; 0.062; 0.081; 0.172; 0.182 | <0.0001 sig |
| SECONDARY Trough FEV1 Response [L] After 6 Weeks Treatment. |
-0.006; 0.109; 0.095; 0.122; 0.196; 0.201 | <0.0001 sig |
| SECONDARY Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment. |
0.072; 0.291; 0.290; 0.300; 0.422; 0.411 | <0.0001 sig |
| SECONDARY FVC AUC0-24h Response [L] After 6 Weeks Treatment. |
-0.065; 0.158; 0.172; 0.191; 0.331; 0.368 | <0.0001 sig |
| SECONDARY FVC AUC0-12h Response [L] After 6 Weeks Treatment. |
-0.023; 0.240; 0.249; 0.261; 0.420; 0.440 | <0.0001 sig |
| SECONDARY FVC AUC12-24h Response [L] After 6 Weeks Treatment. |
-0.108; 0.077; 0.095; 0.122; 0.243; 0.296 | <0.0001 sig |
| SECONDARY Trough FVC Response [L] After 6 Weeks Treatment. |
-0.025; 0.134; 0.115; 0.183; 0.282; 0.304 | <0.0001 sig |
| SECONDARY Peak (0-3h) FVC Response [L] After 6 Weeks Treatment. |
0.159; 0.463; 0.450; 0.470; 0.612; 0.621 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Diagnosis of chronic obstructive pulmonary disease
- Relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal and a post-bronchodilator FEV1/FVC <70%
- Male or female patients, 40 years of age or older
- Smoking history of more than 10 pack years
- Ability to perform technically acceptable pulmonary function tests and maintain records
- Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI)
Exclusion criteria
- significant disease other than COPD
- clinically relevant abnormal lab values
- history of asthma
- diagnosis of thyrotoxicosis
- diagnosis of paroxysmal tachycardia
- history of myocardial infarction
- unstable or life-threatening cardiac arrhythmia
- Hospitalization for heart failure within the past year
- known active tuberculosis
- malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- history of life-threatening pulmonary obstruction
- history of cystic fibrosis
- clinically evident bronchiectasis
- history of significant alcohol or drug abuse
- history of thoracotomy with pulmonary resection
- oral or patch ß-adrenergics
- oral corticosteroid medication at unstable doses
- regular use daytime oxygen therapy for more than one hour per day
- Pulmonary rehabilitation program in the six weeks prior to the screening visit
- Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
- Pregnant or nursing women
- Women of childbearing potential not using a highly effective method of birth control
- Patients who have previously been randomised in this study or are currently participating in another study
- Patients who are unable to comply with pulmonary medication restrictions prior to randomisation
Data sourced from ClinicalTrials.gov (NCT01559116). 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.