Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01533935
First received: February 13, 2012
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, 5 Treatment Arms, 4-period, Incomplete Cross-over Study to Determine the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) (2.5 / 5 µg; and 5 / 5 µg) (Delivered by the Respimat® Inhaler) Compared With Tiotropium (5 µg), Olodaterol (5 µg ) and Placebo (Delivered by the Respimat® Inhaler) on Lung Hyperinflation and Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD) [MORACTO TM 2]

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% Wcap [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Endurance time during constant work rate cycle ergometry to symptom limitation at 75% Wcap [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Slope of the intensity of breathing discomfort (Borg Scale) during constant work rate cycle ergometry to symptom limitation at 75% Wcap [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • FEV1 (1 hour post dose) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 291
Study Start Date: February 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Olodaterol 5 mcg QD
patient will receive olodaterol 5 mcg once daily
Drug: Olodaterol
Olodaterol 5 mcg once daily
Placebo Comparator: Placebo QD
placebo comparator for tiotropium + olodaterol
Drug: tiotropium + olodaterol
placebo matching tiotropium + olodaterol
Active Comparator: Tiotropium 5 mcg QD
patient will receive tiotropium 5 mcg once daily
Drug: Tiotropium
tiotropium
Experimental: Tiotropium + olodaterol low dose QD
patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in fixed dose combination once daily
Drug: Tiotropium + Olodaterol
Tiotropium 2.5 mcg + olodaterol 5 mcg once daily
Experimental: Tiotropium + olodaterol high dose
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily
Drug: tiotropium + Olodaterol
tiotropium 5 mcg + olodaterol 5 mcg once daily

  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 a post-bronchodilator FEV1 <80% of predicted normal and a post-bronchodilator FEV1/FVC <70% at Visit 1.

  3. Male or female patients, between 40 and 75 years of age (inclusive) on day of signing informed consent.
  4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years.

Exclusion criteria:

  1. Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
  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. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.

    Patients with any of the following conditions:

  4. A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists)
  5. A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists)
  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 (patients with treated basal cell carcinoma are allowed)
  11. A history of life-threatening pulmonary obstruction
  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 (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)
  17. Patients being treated with any oral ß-adrenergics
  18. Patients being treated with oral corticosteroid medication at unstable doses
  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 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, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.
  22. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit
  23. Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system
  24. Pregnant or nursing women
  25. Women of childbearing potential not using highly effective methods of birth control.
  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: NCT01533935

  Show 33 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: NCT01533935     History of Changes
Other Study ID Numbers: 1237.14, 2011-004660-30
Study First Received: February 13, 2012
Last Updated: April 30, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Austria: Medicines and Medical Devices Agency
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Central Committee Research Involving Human Subjects
Russia: Pharmacological Committee, Ministry of Health
Sweden: Medical Products Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014