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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

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: FDC of tiotropium + olodaterol Drug: Placebo Drug: Tiotropium Drug: Olodaterol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : March 8, 2016
Actual Primary Completion Date : January 9, 2017
Actual Study Completion Date : January 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol
Drug: FDC of tiotropium + olodaterol
Fixed Dose Combination of tiotropium + olodaterol

Drug: Placebo
Active Comparator: Free combination tiotropium + olodaterol Drug: Tiotropium
Drug: Olodaterol



Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 <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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683109


Locations
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Austria
Ordination Dr. Robert Voves, 8330 Feldbach
Feldbach, Austria, 8330
KH d. Elisabethinen Linz
Linz, Austria, 4020
Denmark
Aarhus Universitetshospital
Aarhus, Denmark, 8000
Hvidovre Hospital
Hvidovre, Denmark, 2650
Regionshospitalet Silkeborg
Silkeborg, Denmark, 8600
Finland
Jorvin sairaala
Espoo, Finland, FI-02740
HYKS Keuhkosairauksien
Helsinki, Finland, 00029
TAYS, Keuhkotautien poliklinikka
Tampere, Finland, FI-33520
TYKS, Keuhkosairauksien klinikka, Turku
Turku, Finland, 20520
Terveystalo Pulssi, Turku
Turku, Finland, FI-20100
France
HOP Louis Pradel
Bron, France, 69677
CLI du Parc, Pneumo, Castelnau le Lez
Castelnau Le Lez, France, 34170
CAB Pigearias B., Pneumo, Nice
Nice, France, 06000
CAB Dupouy J, Pneumo, Nîmes
Nîmes, France, 30900
HOP Cochin
Paris, France, 75014
HOP Haut-Lévêque
Pessac, France, 33604
HOP Maison Blanche
Reims, France, 51092
INS A.Tzanck,Pneumo,St Laurent du Var
Saint Laurent du Var, France, 06721
CAB Lejay D, MG, Vieux Condé
Vieux Condé, France, 59690
Slovenia
Univ. Clinic of Respiratory and Allergic Diseases, Golnik
Golnik, Slovenia, 4204
Verboten Kopriva Renata - Private practice, Litija
Litija, Slovenia, 1270
Arjana Macek d.o.o.
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02683109     History of Changes
Other Study ID Numbers: 1237.49
2015-003879-29 ( EudraCT Number )
First Posted: February 17, 2016    Key Record Dates
Results First Posted: August 17, 2018
Last Update Posted: August 17, 2018
Last Verified: December 2017

Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Olodaterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action