A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Load Cycle Test in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01525615
First received: February 1, 2012
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: tiotropium + olodaterol (high dose)
Drug: tiotropium+olodaterol
Drug: placebo to tiotropium+olodaterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • endurance time during constant work rate cycle ergometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • endurance time during endurance shuttle walk test [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • inspiratory capacity (pre-exercise) during constant work rate cycle ergometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • inspiratory capacity (pre-exercise) during constant work rate cycle ergometry [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • inspiratory capacity (pre-exercise) during constant work rate cycle ergometry [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • slope of the intensity of breathing discomfort during constant work rate cycle ergometry [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • slope of the intensity of breathing discomfort during constant work rate cycle ergometry [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • slope of the intensity of breathing discomfort during constant work rate cycle ergometry [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • 1-hour post-dose FEV1 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • 1-hour post-dose FEV1 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 1-hour post-dose FEV1 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • endurance time during constant work rate cycle ergometry [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • endurance time during constant work rate cycle ergometry [ Time Frame: day 1 ] [ Designated as safety issue: No ]

Enrollment: 404
Study Start Date: February 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tiotropium+olodaterol low dose
once daily 2 puffs, solution for inhalation Respimat
Drug: tiotropium+olodaterol
2.5 µg tiotropium + 5 µg olodaterol
Experimental: tiotropium+olodaterol high dose
once daily 2 puffs, solution for inhalation Respimat
Drug: tiotropium + olodaterol (high dose)
5 µg tiotropium + 5 µg olodaterol
Placebo Comparator: placebo
once daily 2 puffs, solution for inhalation Respimat
Drug: placebo to tiotropium+olodaterol
comparator

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
  2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:

    Patients must have relatively stable airway obstruction with, at visit 1:

    a post-bronchodilator 30% = FEV1 <80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1

  3. Male or female patients, between 40 and 75 years (inclusive) of age on day of signing informed consent.
  4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years Patients who have never smoked cigarettes must be excluded.
  5. Patients must be able to perform technically acceptable pulmonary function tests (spirometry), must be able to complete multiple symptom-limited cycle ergometry tests (and for a subset also shuttle walk tests), as required in the protocol.
  6. Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).

Exclusion criteria:

  1. Patients with a significant disease other than COPD
  2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT > x2 ULN, SGPT > x2 ULN, bilirubin > x2 ULN or creatinine > x2 ULN will be excluded regardless of clinical condition
  3. Patients with a history of asthma
  4. A diagnosis of thyrotoxicosis
  5. A diagnosis of paroxysmal tachycardia (>100 beats per minute)
  6. A history of myocardial infarction within 1 year of screening visit (Visit 1)
  7. Unstable or life-threatening cardiac arrhythmia
  8. Hospitalized for heart failure within the past year
  9. Known active tuberculosis
  10. A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
  11. A history of life-threatening pulmonary obstruction and patients with chronic respiratory failure
  12. A history of cystic fibrosis
  13. Clinically evident bronchiectasis
  14. A history of significant alcohol or drug abuse
  15. Any contraindications for exercise testing
  16. Patients who have undergone thoracotomy with pulmonary resection
  17. Patients being treated with any oral ß-adrenergics
  18. Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
  19. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator¿s opinion will be unable to abstain from the use of oxygen therapy during clinic visits
  20. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
  21. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea or morbid obesity
  22. Patients with an endurance time ¿25 minutes during the training (Visit 2) or baseline (Visit 3) constant work rate cycle ergometry
  23. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1)
  24. Patients with known hypersensitivity to ß-adrenergic drugs, anticholinergic drugs, BAC, EDTA or any other component of the RESPIMAT inhalation solution delivery system
  25. Pregnant or nursing women
  26. Women of childbearing potential not using a highly effective method of birth control*.

    Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years

  27. Patients who have previously been randomized in this study or are currently participating in another study
  28. Patients who are unable to comply with pulmonary medication restrictions prior to randomization

    At sites performing the shuttle walk tests, patients with the following criteria will be excluded from the shuttle walk tests:

  29. Patients who complete level 12 at the incremental shuttle walk test at visit 1a.
  30. Patients with an endurance time ¿15 minutes during the training (Visit 2a) or baseline (visit 3a) endurance shuttle walk test.
  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: NCT01525615

  Show 58 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01525615     History of Changes
Other Study ID Numbers: 1237.15, 2011-004253-11
Study First Received: February 1, 2012
Last Updated: April 3, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Canada: Health Canada
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014