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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01559116
First received: March 19, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium + olodaterol
Drug: tiotropium
Drug: olodaterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled, 6 Treatment, 4 Period, Incomplete Cross-over Trial to Characterise the 24-hour Lung Function Profiles of Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg, 5/5 µg), Tiotropium (2.5 µg, 5 µg) and Olodaterol (5 µg) (Oral Inhalation, Delivered by the Respimat® Inhaler) After 6 Weeks Once Daily Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM]

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • The primary endpoint is FEV1 AUC0-24h response [L] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 AUC0-12h response [L] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • FEV1 AUC12-24h response [L] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Trough FEV1 response [L] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Peak FEV1 responses [L] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Trough FVC response [L] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Peak FVC response [L] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • FVC AUC0-24h response [L] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • FVC AUC0-12h response [L] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • FVC AUC12-24h response [L] [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 219
Study Start Date: March 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tiotropium+olodaterol FDC low dose
tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing)
Drug: tiotropium + olodaterol
low dose + one dose only
Experimental: tiotropium+olodaterol FDC high dose
tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing)
Drug: tiotropium + olodaterol
low dose + one dose only
Active Comparator: tiotropium low dose
tiotropium low dose; 2 inhalations once daily (a.m. dosing)
Drug: tiotropium
low dose
Active Comparator: tiotropium high dose
tiotropium high dose; 2 inhalations once daily (a.m. dosing)
Drug: tiotropium
high dose
Active Comparator: olodaterol
one dose only; 2 inhalations once daily (a.m. dosing)
Drug: olodaterol
one dose only
Placebo Comparator: placebo
2 inhalations once daily (a.m. dosing)
Drug: tiotropium + olodaterol
placebo matching tiotropium+olodaterol FDC

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Diagnosis of chronic obstructive pulmonary disease
  2. Relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal and a post-bronchodilator FEV1/FVC <70%
  3. Male or female patients, 40 years of age or older
  4. Smoking history of more than 10 pack years
  5. Ability to perform technically acceptable pulmonary function tests and maintain records
  6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI)

Exclusion criteria:

  1. significant disease other than COPD
  2. clinically relevant abnormal lab values
  3. history of asthma
  4. diagnosis of thyrotoxicosis
  5. diagnosis of paroxysmal tachycardia
  6. history of myocardial infarction
  7. unstable or life-threatening cardiac arrhythmia
  8. Hospitalization for heart failure within the past year
  9. known active tuberculosis
  10. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
  11. history of life-threatening pulmonary obstruction
  12. history of cystic fibrosis
  13. clinically evident bronchiectasis
  14. history of significant alcohol or drug abuse
  15. history of thoracotomy with pulmonary resection
  16. oral or patch ß-adrenergics
  17. oral corticosteroid medication at unstable doses
  18. regular use daytime oxygen therapy for more than one hour per day
  19. Pulmonary rehabilitation program in the six weeks prior to the screening visit
  20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
  21. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
  22. Pregnant or nursing women
  23. Women of childbearing potential not using a highly effective method of birth control
  24. Patients who have previously been randomised in this study or are currently participating in another study
  25. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559116

Locations
United States, Alabama
1237.20.1204 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
United States, South Carolina
1237.20.1203 Boehringer Ingelheim Investigational Site
Easley, South Carolina, United States
1237.20.1201 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1237.20.1202 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
Belgium
1237.20.32203 Boehringer Ingelheim Investigational Site
Genk, Belgium
1237.20.32201 Boehringer Ingelheim Investigational Site
Gent, Belgium
1237.20.32204 Boehringer Ingelheim Investigational Site
Jambes, Belgium
Canada, Quebec
1237.20.02201 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec, Canada
Canada
1237.20.02202 Boehringer Ingelheim Investigational Site
Quebec, Canada
Denmark
1237.20.45002 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
1237.20.45003 Boehringer Ingelheim Investigational Site
Odense C, Denmark
1237.20.45001 Boehringer Ingelheim Investigational Site
Silkeborg, Denmark
Germany
1237.20.49205 Boehringer Ingelheim Investigational Site
Berlin, Germany
1237.20.49204 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
1237.20.49206 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1237.20.49203 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1237.20.49201 Boehringer Ingelheim Investigational Site
Mannheim, Germany
1237.20.49207 Boehringer Ingelheim Investigational Site
Mönchengladbach, Germany
1237.20.49202 Boehringer Ingelheim Investigational Site
Wiesbaden, Germany
Hungary
1237.20.36202 Boehringer Ingelheim Investigational Site
Gödöllö, Hungary
1237.20.36204 Boehringer Ingelheim Investigational Site
Komarom, Hungary
1237.20.36203 Boehringer Ingelheim Investigational Site
Pecs, Hungary
1237.20.36201 Boehringer Ingelheim Investigational Site
Szarvas, Hungary
1237.20.36205 Boehringer Ingelheim Investigational Site
Szazhalombatta, Hungary
Netherlands
1237.20.31205 Boehringer Ingelheim Investigational Site
Almelo, Netherlands
1237.20.31202 Boehringer Ingelheim Investigational Site
Breda, Netherlands
1237.20.31201 Boehringer Ingelheim Investigational Site
Heerlen, Netherlands
1237.20.31204 Boehringer Ingelheim Investigational Site
Hengelo, Netherlands
1237.20.31203 Boehringer Ingelheim Investigational Site
Zutphen, Netherlands
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01559116     History of Changes
Other Study ID Numbers: 1237.20, 2011-004710-42
Study First Received: March 19, 2012
Last Updated: April 3, 2014
Health Authority: Belgium: Federal Public Service Health, Food Chain Safety, Environment
Canada: Health Canada
Denmark: The Danish Health and Medicines Authority
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Netherlands: Central Committee Research Involving Human Subjects
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 30, 2014