Pulmonary Disease, Chronic ObstructivePhase 3NCT01533935

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

A Phase 3 study testing Tiotropium + Olodaterol, Tiotropium and Olodaterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 33 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium + Olodaterol, Tiotropium and Olodaterol
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 291 participants
Where: 33 sitesin 8 countries
Study dates: Feb 2012to Nov 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
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.
Male or female patients, between 40 and 75 years of age (inclusive) on day of signing informed consent.
Patients must be current or ex-smokers with a smoking history of more than 10 pack years.

Who cannot join

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
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
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:
A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists)
A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists)

Show all 26Show fewer

A history of myocardial infarction within 1 year of screening visit (Visit 1)
Unstable or life-threatening cardiac arrhythmia
Hospitalized for heart failure within the past year
Known active tuberculosis
A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
A history of life-threatening pulmonary obstruction
A history of cystic fibrosis
Clinically evident bronchiectasis
A history of significant alcohol or drug abuse
Any contraindications for exercise testing.
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)
Patients being treated with any oral ß-adrenergics
Patients being treated with oral corticosteroid medication at unstable doses
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
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
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.
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit
Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system
Pregnant or nursing women
Women of childbearing potential not using highly effective methods of birth control.

Trial locations and contacts

33 sites in 8 countries.

Country

City, postcode or hospital

33 sites in 8 countries

United States11 sites

1237.14.01414 Boehringer Ingelheim Investigational Site
Austell, Georgia
1237.14.01417 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1237.14.01409 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1237.14.01412 Boehringer Ingelheim Investigational Site
Dallas, Texas
1237.14.01407 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1237.14.01404 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1237.14.01418 Boehringer Ingelheim Investigational Site
Rochester, Minnesota
1237.14.01408 Boehringer Ingelheim Investigational Site
Saint Charles, Missouri
1237.14.01410 Boehringer Ingelheim Investigational Site
Seattle, Washington
1237.14.01403 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
1237.14.01401 Boehringer Ingelheim Investigational Site
Union, South Carolina

Other trials in United States

Germany6 sites

1237.14.49406 Boehringer Ingelheim Investigational Site
Bamberg
1237.14.49404 Boehringer Ingelheim Investigational Site
Bochum
1237.14.49401 Boehringer Ingelheim Investigational Site
Großhansdorf
1237.14.49405 Boehringer Ingelheim Investigational Site
Hamburg
1237.14.49403 Boehringer Ingelheim Investigational Site
Hanover
1237.14.49402 Boehringer Ingelheim Investigational Site
Kiel

Other trials in Germany

Netherlands5 sites

1237.14.31001 Boehringer Ingelheim Investigational Site
Heerlen
1237.14.31005 Boehringer Ingelheim Investigational Site
Hoofddorp
1237.14.31004 Boehringer Ingelheim Investigational Site
Hoorn
1237.14.31006 Medisch Centrum Leeuwarden
Leeuwarden
1237.14.31007 Boehringer Ingelheim Investigational Site
Leiden

Other trials in Netherlands

Canada4 sites

1237.14.11402 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1237.14.11401 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec
1237.14.11403 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1237.14.11404 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

Argentina2 sites

1237.14.54402 Boehringer Ingelheim Investigational Site
Buenos Aires
1237.14.54401 Boehringer Ingelheim Investigational Site
Mendoza

Other trials in Argentina

Austria2 sites

1237.14.43402 Boehringer Ingelheim Investigational Site
Grieskirchen
1237.14.43401 Boehringer Ingelheim Investigational Site
Neumarkt am Wallersee

Other trials in Austria

Russia2 sites

1237.14.70401 Boehringer Ingelheim Investigational Site
Moscow
1237.14.70402 Boehringer Ingelheim Investigational Site
Saint Petersburg

Other trials in Russia

Sweden1 site

1237.14.46001 Boehringer Ingelheim Investigational Site
Lund

Other trials in Sweden

About this study

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]

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Placebo, Tiotropium + Olodaterol, Tiotropium, Olodaterol, Respimat
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
placebo matching tiotropium + olodaterol
Tiotropium + OlodaterolDrug
Tiotropium 2.5 mcg + olodaterol 5 mcg once daily
tiotropium + OlodaterolDrug
tiotropium 5 mcg + olodaterol 5 mcg once daily
TiotropiumDrug
tiotropium
OlodaterolDrug
Olodaterol 5 mcg once daily
RespimatDevice
Respimat inhaler

Study groups in NCT01533935
Study group	Role	What they receive
Olodaterol 5 mcg QD	Active comparator	patient will receive olodaterol 5 mcg once daily Receives: Drug: Olodaterol; Device: Respimat
Placebo QD	Placebo comparator	placebo comparator for tiotropium + olodaterol Receives: Drug: Placebo; Device: Respimat
Tiotropium 5 mcg QD	Active comparator	patient will receive tiotropium 5 mcg once daily Receives: Drug: Tiotropium; Device: Respimat
Tiotropium + olodaterol low dose QD	Experimental	patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in fixed dose combination once daily Receives: Drug: Tiotropium + Olodaterol; Device: Respimat
Tiotropium + olodaterol high dose	Experimental	patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily Receives: Drug: tiotropium + Olodaterol; Device: Respimat

What is being measured

The primary outcome is the main question the study is designed to answer.

Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity
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.
Measured: 6 weeks
Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
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.
Measured: 6 weeks

Secondary outcomes (2)

Slope of the Intensity of Breathing Discomfort (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap
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.
Measured: 6 weeks
FEV1 (1 Hour Post-dose)
Forced Expiratory Volume in 1 Second (FEV1) (one hour post-dose).
The presented means are adjusted means from MMRM model.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012Nov 2013

First posted16 Feb 2012 (estimated)
Study startFeb 2012
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 291 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01533935
Sponsor's protocol ID: 1237.14
Other IDs: 2011-004660-30
Status last verified: Aug 2015
First submitted: 13 Feb 2012
Last updated: 15 Sep 2015
Results posted: Yes, on ClinicalTrials.gov

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.
PubMed 28424359

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 3
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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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]
ClinicalTrials.gov ID: NCT01533935
Acronym / sponsor ID: 1237.14
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 291 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 16 Feb 2012 (estimated)
Results: Posted 15 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 5

Arm	Type	Receives
Olodaterol 5 mcg QD	Active comparator	Drug: Olodaterol, Device: Respimatpatient will receive olodaterol 5 mcg once daily
Placebo QD	Placebo comparator	Drug: Placebo, Device: Respimatplacebo comparator for tiotropium + olodaterol
Tiotropium 5 mcg QD	Active comparator	Drug: Tiotropium, Device: Respimatpatient will receive tiotropium 5 mcg once daily
Tiotropium + olodaterol low dose QD	Experimental	Drug: Tiotropium + Olodaterol, Device: Respimatpatient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in fixed dose combination once daily
Tiotropium + olodaterol high dose	Experimental	Drug: tiotropium + Olodaterol, Device: Respimatpatient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
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.
Male or female patients, between 40 and 75 years of age (inclusive) on day of signing informed consent.
Patients must be current or ex-smokers with a smoking history of more than 10 pack years.

Key exclusion criteria (26 listed)

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
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
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.
A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists)
A diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Placeboplacebo matching tiotropium + olodaterol	Drug	Placebo QD
Tiotropium + OlodaterolTiotropium 2.5 mcg + olodaterol 5 mcg once daily	Drug	Tiotropium + olodaterol low dose QD
tiotropium + Olodateroltiotropium 5 mcg + olodaterol 5 mcg once daily	Drug	Tiotropium + olodaterol high dose
Tiotropiumtiotropium	Drug	Tiotropium 5 mcg QD
OlodaterolOlodaterol 5 mcg once daily	Drug	Olodaterol 5 mcg QD
RespimatRespimat inhaler	Device	Olodaterol 5 mcg QD, Placebo QD, Tiotropium + olodaterol high dose, Tiotropium + olodaterol low dose QD, Tiotropium 5 mcg QD

Primary outcome

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.

2 secondary outcomes

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
FEV1 (1 Hour Post-dose)
Time frame: 6 weeks

Results and safety

Results posted to the registry on 15 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo	58	52
Tio+Olo 5/5 / Tio / Olo / Placebo	58	45
Tio / Olo / Placebo / Tio+Olo 2.5/5	58	50
Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5	59	52
Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio	58	50

Primary outcome: Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity

Time frame: 6 weeks. Mean (Standard Error). Unit: Litres

Measure	Placebo n = 202	Olodaterol 5 µg n = 208	Tiotropium 5 µg n = 208	Tiotropium + Olodaterol 2.5/5 n = 212	Tiotropium + Olodaterol 5/5 n = 218
Value	2.502 (0.026)	2.687 (0.025)	2.679 (0.025)	2.776 (0.025)	2.767 (0.025)

Placebo vs Tiotropium + Olodaterol 5/5: Mean Difference (Final Values): 0.265 (95% CI 0.215 to 0.315), p <0.0001, Mixed Models Analysis
Olodaterol 5 µg vs Tiotropium + Olodaterol 5/5: Mean Difference (Final Values): 0.080 (95% CI 0.031 to 0.129), p = 0.0015, Mixed Models Analysis
Tiotropium 5 µg vs Tiotropium + Olodaterol 5/5: Mean Difference (Final Values): 0.088 (95% CI 0.039 to 0.137), p = 0.0005, Mixed Models Analysis

Population analysed: Full Analysis Set (FAS) : This patient set included all patients in the TS who had the study baseline and at least 1 evaluable post-dose measurement for 1 of the primary endpoints. Assignment to the FAS was done after implementation of any data handling rules,which set measurements to missing.

Primary outcome: Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap

Time frame: 6 weeks. Geometric mean (Standard Error). Unit: seconds

Measure	Placebo n = 205	Olodaterol 5 µg n = 207	Tiotropium 5 µg n = 209	Tiotropium + Olodaterol 2.5/5 n = 212	Tiotropium + Olodaterol 5/5 n = 216
Value	410.77 (12.009)	419.06 (12.207)	446.50 (12.958)	460.66 (13.310)	465.68 (13.359)

Placebo vs Tiotropium + Olodaterol 5/5: Ratio: 1.134 (95% CI 1.065 to 1.206), p <0.0001, Mixed Models Analysis
Olodaterol 5 µg vs Tiotropium + Olodaterol 5/5: Ratio: 1.111 (95% CI 1.045 to 1.182), p = 0.0009, Mixed Models Analysis
Tiotropium 5 µg vs Tiotropium + Olodaterol 5/5: Ratio: 1.043 (95% CI 0.981 to 1.109), p = 0.1807, Mixed Models Analysis

Population analysed: FAS

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until 21 days after the last administration, up to 139 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 214 (1.4%)	41 of 214 (19.2%)	Not reported
Olodaterol 5 µg	3 of 218 (1.4%)	42 of 218 (19.3%)	Not reported
Tiotropium 5 µg	8 of 218 (3.7%)	48 of 218 (22%)	Not reported
Tiotropium + Olodaterol 2.5/5	3 of 219 (1.4%)	36 of 219 (16.4%)	Not reported
Tiotropium + Olodaterol 5/5	4 of 224 (1.8%)	40 of 224 (17.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28424359O'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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

33 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tiotropium + Olodaterol, Tiotropium and Olodaterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 33 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Germany, Netherlands, Canada, Argentina and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01533935, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.