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Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD

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ClinicalTrials.gov Identifier: NCT02683109
Recruitment Status : Completed
First Posted : February 17, 2016
Results First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE February 12, 2016
First Posted Date  ICMJE February 17, 2016
Results First Submitted Date  ICMJE December 7, 2017
Results First Posted Date  ICMJE August 17, 2018
Last Update Posted Date August 17, 2018
Actual Study Start Date  ICMJE March 8, 2016
Actual Primary Completion Date January 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
Trough Forced Expiratory Volume in 1 Second (FEV1) (in Liter) After 28 Days of Treatment [ Time Frame: Day 29 ]
This outcome measure presents FEV1 after 28 days of treatment (measurement on Day 29). Trough FEV1 was defined as the FEV1 value at the end of the dosing interval (24 hours), and was measured at 24 hours (+/- 10 minutes) after trial medication administration at Visit 5. The FEV1 measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
Trough Forced Expiratory Volume in 1 second (FEV1) [in Liter] after 28 days of treatment (measurement on Day 29) [ Time Frame: Day 29 ]
Change History Complete list of historical versions of study NCT02683109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • Trough Forced Vital Capacity (FVC) (in Liter) After 28 Days of Treatment [ Time Frame: Day 29 ]
    This outcome measure presents trough FVC after 28 days of treatment (measurement on Day 29). The FVC measurement at Visit 4, which was 24 hours after the last open-label run-in treatment intake and 15 minutes before the first double-blind study drug intake was the baseline measurement for FVC.
  • Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28 [ Time Frame: Day 28 ]
    This outcome measure presents COPD assessment test score on Day 28. The COPD Assessment Test™ is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT measurement on Visit 4 prior to the first dose of double-blind study drug was the baseline for CAT.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
  • Trough Forced Vital Capacity (FVC) [in Liter] after 28 days of treatment (measurement on Day 29) [ Time Frame: Day 29 ]
  • Chronic Obstructive Pulmonary Disease (COPD) Assessment Test™ (CAT) Score on Day 28 [ Time Frame: Day 28 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD
Official Title  ICMJE A 4-week, Randomised, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Delivered by the Respimat® Inhaler Versus the Free Combination of Tiotropium 5 µg and Olodaterol 5 µg Delivered by Separate Respimat® Inhalers in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: FDC of tiotropium + olodaterol
    Fixed Dose Combination of tiotropium + olodaterol
  • Drug: Placebo
  • Drug: Tiotropium
  • Drug: Olodaterol
Study Arms  ICMJE
  • Experimental: FDC of tiotropium + olodaterol
    Fixed Dose Combination of tiotropium + olodaterol
    Interventions:
    • Drug: FDC of tiotropium + olodaterol
    • Drug: Placebo
  • Active Comparator: Free combination tiotropium + olodaterol
    Interventions:
    • Drug: Tiotropium
    • Drug: Olodaterol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2017)
221
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2016)
220
Actual Study Completion Date  ICMJE January 30, 2017
Actual Primary Completion Date January 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 <80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70% at screening.
  • Symptomatic patients with CAT (COPD Assessment Test TM) score >= 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Denmark,   Finland,   France,   Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02683109
Other Study ID Numbers  ICMJE 1237.49
2015-003879-29 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP