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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01533922




Registration number
NCT01533922
Ethics application status
Date submitted
13/02/2012
Date registered
16/02/2012
Date last updated
15/09/2015

Titles & IDs
Public title
Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients
Scientific 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 1]
Secondary ID [1] 0 0
2011-004659-37
Secondary ID [2] 0 0
1237.13
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Tiotropium
Treatment: Drugs - Olodaterol
Treatment: Drugs - tiotropium + olodaterol
Treatment: Drugs - Tiotropium + Olodaterol
Treatment: Devices - Respimat

Experimental: Tiotropium + olodaterol High dose QD - patient will receive tiotropium 5 mcg + olodaterol 5 mcg in a fixed dose combination once daily

Experimental: Tiotropium + olodaterol Low dose QD - patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in a fixed dose combination once daily

Active comparator: Tiotropium 5 mcg QD - patient will receive tiotropium 5 mcg once daily

Active comparator: Olodaterol 5 mcg QD - patient will receive olodaterol 5 mcg once daily

Placebo comparator: Placebo QD -


Treatment: Drugs: Placebo
placebo matching tiotropium + olodaterol FDC

Treatment: Drugs: Tiotropium
Tiotropium 5 mcg once daily

Treatment: Drugs: Olodaterol
Olodaterol 5 mcg once daily

Treatment: Drugs: tiotropium + olodaterol
tiotropium + olodaterol 5 mcg once daily

Treatment: Drugs: Tiotropium + Olodaterol
Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily

Treatment: Devices: Respimat
Respimat inhaler
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
Timepoint [2] 0 0
6 weeks
Secondary outcome [1] 0 0
Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Forced Expiratory Volume in 1 Second (One Hour Post-dose)
Timepoint [2] 0 0
6 weeks

Eligibility
Key inclusion 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.
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
295
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
1237.13.61306 Boehringer Ingelheim Investigational Site - Concord
Recruitment hospital [2] 0 0
1237.13.61301 Boehringer Ingelheim Investigational Site - Daw Park
Recruitment hospital [3] 0 0
1237.13.61305 Boehringer Ingelheim Investigational Site - Toorak Gardens
Recruitment hospital [4] 0 0
1237.13.61304 Boehringer Ingelheim Investigational Site - Footscray
Recruitment hospital [5] 0 0
1237.13.61302 Boehringer Ingelheim Investigational Site - Prahran
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Daw Park
Recruitment postcode(s) [3] 0 0
- Toorak Gardens
Recruitment postcode(s) [4] 0 0
- Footscray
Recruitment postcode(s) [5] 0 0
- Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
United States of America
State/province [5] 0 0
South Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Argentina
State/province [7] 0 0
Capital Federal
Country [8] 0 0
Argentina
State/province [8] 0 0
Mar del Plata
Country [9] 0 0
Austria
State/province [9] 0 0
Linz
Country [10] 0 0
Austria
State/province [10] 0 0
Thalheim bei Wels
Country [11] 0 0
Belgium
State/province [11] 0 0
Brussel
Country [12] 0 0
Belgium
State/province [12] 0 0
Edegem
Country [13] 0 0
Belgium
State/province [13] 0 0
Jambes
Country [14] 0 0
Belgium
State/province [14] 0 0
Lanaken
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Saskatchewan
Country [18] 0 0
Chile
State/province [18] 0 0
Chile
Country [19] 0 0
Chile
State/province [19] 0 0
Santiago de Chile
Country [20] 0 0
Germany
State/province [20] 0 0
Berlin
Country [21] 0 0
Germany
State/province [21] 0 0
Dortmund
Country [22] 0 0
Germany
State/province [22] 0 0
Frankfurt
Country [23] 0 0
Germany
State/province [23] 0 0
Halle
Country [24] 0 0
Germany
State/province [24] 0 0
Hannover
Country [25] 0 0
Germany
State/province [25] 0 0
Lübeck
Country [26] 0 0
Italy
State/province [26] 0 0
Genova
Country [27] 0 0
Italy
State/province [27] 0 0
Parma
Country [28] 0 0
Italy
State/province [28] 0 0
Pavia
Country [29] 0 0
Italy
State/province [29] 0 0
Pavullo Nel Frignano (mo)
Country [30] 0 0
Italy
State/province [30] 0 0
Pisa
Country [31] 0 0
Italy
State/province [31] 0 0
Roma
Country [32] 0 0
Italy
State/province [32] 0 0
Sesto S. Giovanni (mi)
Country [33] 0 0
Italy
State/province [33] 0 0
Trieste
Country [34] 0 0
New Zealand
State/province [34] 0 0
Christchurch
Country [35] 0 0
New Zealand
State/province [35] 0 0
Greenlane East Auckland NZ

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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
Trial website
https://clinicaltrials.gov/study/NCT01533922
Trial related presentations / publications
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):1601348. doi: 10.1183/13993003.01348-2016. Print 2017 Apr.
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01533922