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

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ClinicalTrials.gov Identifier: NCT01533935
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : September 15, 2015
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

February 13, 2012
February 16, 2012
June 19, 2015
September 15, 2015
September 15, 2015
February 2012
November 2013   (Final data collection date for primary outcome measure)
  • Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity [ Time Frame: 6 weeks ]
    Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model.
  • Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap [ Time Frame: 6 weeks ]
    Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% Wcap Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted mean from the MMRM model.
  • Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap [ Time Frame: 6 weeks ]
  • Inspiratory capacity (IC) at isotime during constant work rate cycle ergometry to symptom limitation at 75% Wcap [ Time Frame: 6 weeks ]
Complete list of historical versions of study NCT01533935 on ClinicalTrials.gov Archive Site
  • 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 ]
    Slope of the intensity of breathing discomfort (Borg Scale) during CWRCE to symptom limitation at 75% Wcap. The intensity of breathing discomfort was rated using the modified Borg scale with ratings from 0 (nothing at all) to 10 (maximal). Slope is defined as : (intensity of breathing discomfort at the end of exercise minus intensity of breathing discomfort at rest) / endurance time. A decrease in slope indicates improvement. The presented means are adjusted means from MMRM model.
  • FEV1 (1 Hour Post-dose) [ Time Frame: 6 weeks ]
    Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose). The presented means are adjusted means from MMRM model.
  • FEV1 [ Time Frame: 6 weeks ]
  • FVC [ Time Frame: 6 weeks ]
  • Intensity of breathing discomfort (Borg Scale) at isotime during constant work rate cycle ergometry to symptom limitation at 75% Wcap [ Time Frame: 6 weeks ]
  • Inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% Wcap: pre-exercise, during exercise and at end exercise [ Time Frame: 6 weeks ]
  • Intensity of breathing discomfort (Borg Category-Ratio Scale) during constant work rate cycle ergometry to symptom limitation at 75% Wcap: pre-exercise, during exercise and at end-exercise [ Time Frame: 6 weeks ]
  • Intensity of leg discomfort (Borg Category-Ratio Scale) during constant work rate cycle ergometry to symptom limitation at 75% Wcap: pre-exercise, exercise and at end-exercise [ Time Frame: 6 weeks ]
  • Locus of symptom limitation during constant work rate cycle ergometry to symptom limitation at 75% Wcap [ Time Frame: 6 weeks ]
Not Provided
Not Provided
 
Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.
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]
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Placebo
    placebo matching tiotropium + olodaterol
  • Drug: Tiotropium + Olodaterol
    Tiotropium 2.5 mcg + olodaterol 5 mcg once daily
  • Drug: tiotropium + Olodaterol
    tiotropium 5 mcg + olodaterol 5 mcg once daily
  • Drug: Tiotropium
    tiotropium
  • Drug: Olodaterol
    Olodaterol 5 mcg once daily
  • Device: Respimat
    Respimat inhaler
  • Active Comparator: Olodaterol 5 mcg QD
    patient will receive olodaterol 5 mcg once daily
    Interventions:
    • Drug: Olodaterol
    • Device: Respimat
  • Placebo Comparator: Placebo QD
    placebo comparator for tiotropium + olodaterol
    Interventions:
    • Drug: Placebo
    • Device: Respimat
  • Active Comparator: Tiotropium 5 mcg QD
    patient will receive tiotropium 5 mcg once daily
    Interventions:
    • Drug: Tiotropium
    • Device: Respimat
  • Experimental: Tiotropium + olodaterol low dose QD
    patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in fixed dose combination once daily
    Interventions:
    • Drug: Tiotropium + Olodaterol
    • Device: Respimat
  • Experimental: Tiotropium + olodaterol high dose
    patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily
    Interventions:
    • Drug: tiotropium + Olodaterol
    • Device: Respimat
O'Donnell DE, Casaburi R, Frith P, Kirsten A, De Sousa D, Hamilton A, Xue W, Maltais F. Effects of combined tiotropium/olodaterol on inspiratory capacity and exercise endurance in COPD. Eur Respir J. 2017 Apr 19;49(4). pii: 1601348. doi: 10.1183/13993003.01348-2016. Print 2017 Apr.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
291
280
November 2013
November 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Canada,   Germany,   Netherlands,   Russian Federation,   Sweden,   United States
Colombia
 
NCT01533935
1237.14
2011-004660-30 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP