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Completed

NCT Number: NCT02683109

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ordination Dr. Robert Voves, 8330 Feldbach, Feldbach, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FDC of tiotropium + olodaterol

Drug

Fixed Dose Combination of tiotropium + olodaterol

Placebo

Drug

Tiotropium

Drug

Olodaterol

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2016
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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