Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Placebo; Drug: tiotropium + olodaterol; Drug: tiotropium; Drug: olodaterol; Device: Respimat

• Registration Number: NCT01559116
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-20
• Study First Posted: 2012-03-21
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Disposition First Submitted: 2014-04-03
• Disposition First Submitted QC: 2014-04-03
• Disposition First Posted: 2014-04-30
• Status Verified: 2015-06
• Results First Submitted: 2015-06-19
• Results First Submitted QC: 2015-06-19
• Last Update Submitted: 2015-06-19
• Results First Posted: 2015-07-16
• Last Update Posted: 2015-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tiotropium low dose	Respimat	tiotropium low dose; 2 inhalations once daily (a.m. dosing)
tiotropium+olodaterol FDC low dose	Respimat	tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing)
olodaterol	Respimat	one dose only; 2 inhalations once daily (a.m. dosing)
placebo	Placebo	2 inhalations once daily (a.m. dosing)
placebo	Respimat	2 inhalations once daily (a.m. dosing)
tiotropium+olodaterol FDC high dose	tiotropium + olodaterol	tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing)
tiotropium+olodaterol FDC high dose	Respimat	tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing)
tiotropium low dose	tiotropium	tiotropium low dose; 2 inhalations once daily (a.m. dosing)
tiotropium+olodaterol FDC low dose	tiotropium + olodaterol	tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing)
tiotropium high dose	Respimat	tiotropium high dose; 2 inhalations once daily (a.m. dosing)
tiotropium high dose	tiotropium	tiotropium high dose; 2 inhalations once daily (a.m. dosing)
olodaterol	olodaterol	one dose only; 2 inhalations once daily (a.m. dosing)

Primary Outcome Measures

Name	Time	Method
Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.	day 1 and week 6	Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres.; Mean is actually the Adjusted mean.; The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

Secondary Outcome Measures

Name	Time	Method
FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.	day 1 and week 6	Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 12 h post-dose, using the trapezoidal rule, divided by the duration (12h) to report in litres.; Mean is actually the Adjusted mean.; The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.	day 1 and week 6	Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.; Mean is actually the Adjusted mean.; The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.	day 1 and week 6	Peak (0-3h) Forced Expiratory Volume in 1 second (FEV1) response.; The peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.; Mean is actually the Adjusted mean.; The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Trough FEV1 Response [L] After 6 Weeks Treatment.	day 1 and week 6	Trough Forced Expiratory Volume in 1 second (FEV1) response after 6 weeks treatment period.; The trough was defined as the mean of the 23 h and 23 h50 min measurements and Response was defined as the change from patient baseline.; Mean is actually the Adjusted mean.; The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
FVC AUC0-24h Response [L] After 6 Weeks Treatment.	day 1 and week 6	Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.; Mean is actually the Adjusted mean.; The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
FVC AUC0-12h Response [L] After 6 Weeks Treatment.	day 1 and week 6	Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.; Mean is actually the Adjusted mean.; The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
FVC AUC12-24h Response [L] After 6 Weeks Treatment.	day 1 and week 6	Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.; Mean is actually the Adjusted mean.; The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Trough FVC Response [L] After 6 Weeks Treatment.	day1 and week 6	Trough Forced Vital Capacity (FVC) response after 6 weeks treatment period.; The trough was defined as the mean of the 23 h and 23 h50 min measurements and response was defined as the change from patient baseline.; Mean is actually the Adjusted mean.; The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.	day 1 and week 6	Peak (0-3h) Forced Vital Capacity (FVC) responses after 6 weeks treatment.; Peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.; Mean is actually the Adjusted mean.; The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

Trial Locations

Locations (29)

1237.20.32201 Boehringer Ingelheim Investigational Site; 🇧🇪 Gent, Belgium

1237.20.31204 Boehringer Ingelheim Investigational Site; 🇳🇱 Hengelo, Netherlands

1237.20.36201 Boehringer Ingelheim Investigational Site; 🇭🇺 Szarvas, Hungary

1237.20.36205 Boehringer Ingelheim Investigational Site; 🇭🇺 Szazhalombatta, Hungary

1237.20.49205 Boehringer Ingelheim Investigational Site; 🇩🇪 Berlin, Germany

1237.20.36204 Boehringer Ingelheim Investigational Site; 🇭🇺 Komarom, Hungary

1237.20.32203 Boehringer Ingelheim Investigational Site; 🇧🇪 Genk, Belgium

1237.20.31202 Boehringer Ingelheim Investigational Site; 🇳🇱 Breda, Netherlands

1237.20.31203 Boehringer Ingelheim Investigational Site; 🇳🇱 Zutphen, Netherlands

1237.20.36203 Boehringer Ingelheim Investigational Site; 🇭🇺 Pecs, Hungary

1237.20.49202 Boehringer Ingelheim Investigational Site; 🇩🇪 Wiesbaden, Germany

1237.20.31205 Boehringer Ingelheim Investigational Site; 🇳🇱 Almelo, Netherlands

1237.20.31201 Boehringer Ingelheim Investigational Site; 🇳🇱 Heerlen, Netherlands

1237.20.36202 Boehringer Ingelheim Investigational Site; 🇭🇺 Gödöllö, Hungary

1237.20.45002 Boehringer Ingelheim Investigational Site; 🇩🇰 Hvidovre, Denmark

1237.20.45003 Boehringer Ingelheim Investigational Site; 🇩🇰 Odense C, Denmark

1237.20.02202 Boehringer Ingelheim Investigational Site; 🇨🇦 Quebec, Canada

1237.20.1204 Boehringer Ingelheim Investigational Site; 🇺🇸 Jasper, Alabama, United States

1237.20.1202 Boehringer Ingelheim Investigational Site; 🇺🇸 Spartanburg, South Carolina, United States

1237.20.1201 Boehringer Ingelheim Investigational Site; 🇺🇸 Greenville, South Carolina, United States

1237.20.32204 Boehringer Ingelheim Investigational Site; 🇧🇪 Jambes, Belgium

1237.20.02201 Boehringer Ingelheim Investigational Site; 🇨🇦 Sherbrooke, Quebec, Canada

1237.20.45001 Boehringer Ingelheim Investigational Site; 🇩🇰 Silkeborg, Denmark

1237.20.49204 Boehringer Ingelheim Investigational Site; 🇩🇪 Großhansdorf, Germany

1237.20.49203 Boehringer Ingelheim Investigational Site; 🇩🇪 Hamburg, Germany

1237.20.49206 Boehringer Ingelheim Investigational Site; 🇩🇪 Hamburg, Germany

1237.20.49201 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany

1237.20.49207 Boehringer Ingelheim Investigational Site; 🇩🇪 Mönchengladbach, Germany

1237.20.1203 Boehringer Ingelheim Investigational Site; 🇺🇸 Easley, South Carolina, United States