Pulmonary Disease, Chronic ObstructivePhase 3NCT02085161

To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways

A Phase 3 study testing tiotropium+olodaterol, tiotropium +olodaterol and tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 34 sites in 11 countries.

Completed

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

Official record

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Trial summary

The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity 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 +olodaterol and tiotropium
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 304 participants
Where: 34 sitesin 11 countries
Study dates: Mar 2014to Oct 2015
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 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (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 forced expiratory volume in one second >=30% and <80% of predicted normal; Global Initiative for Chronic Obstructive Lung Disease grade II - III, and a post-bronchodilator Tiffeneau index <70% at Visit 1.
Male or female patients, aged >=40 years and <=75 years.
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.

Who cannot join

Patients with a significant disease other than chronic obstructive pulmonary disease.
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis.
Patients with a history of asthma.
A diagnosis of thyrotoxicosis.
A diagnosis of paroxysmal tachycardia (>100 beats per minute).
A history of myocardial infarction within 1 year of screening visit.

Show all 26Show fewer

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.
A history of life-threatening pulmonary obstruction and patients with chronic respiratory failure.
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 being treated with any oral ß-adrenergics.
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.
Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigators 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, benzalkonium chloride, disodium edentat, 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.
Patients who have previously been randomized in this study or are currently participating in another study.

Trial locations and contacts

34 sites in 11 countries.

Country

City, postcode or hospital

34 sites in 11 countries

Germany9 sites

Boehringer Ingelheim Investigational Site
Berlin
Boehringer Ingelheim Investigational Site
Bochum
Boehringer Ingelheim Investigational Site
Frankfurt
Boehringer Ingelheim Investigational Site
Großhansdorf
Boehringer Ingelheim Investigational Site
Heidelberg
Boehringer Ingelheim Investigational Site
Leverkusen
Boehringer Ingelheim Investigational Site
Solingen
Boehringer Ingelheim Investigational Site
Teuchern
Boehringer Ingelheim Investigational Site
Tübingen

Other trials in Germany

United States3 sites

Boehringer Ingelheim Investigational Site
Hartford, Connecticut
Boehringer Ingelheim Investigational Site
San Diego, California
Boehringer Ingelheim Investigational Site
Torrance, California

Other trials in United States

Belgium3 sites

Boehringer Ingelheim Investigational Site
Genk
Boehringer Ingelheim Investigational Site
Hasselt
Boehringer Ingelheim Investigational Site
Leuven

Other trials in Belgium

Canada3 sites

Boehringer Ingelheim Investigational Site
Montreal, Quebec
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec

Other trials in Canada

Denmark3 sites

Boehringer Ingelheim Investigational Site
København NV
Boehringer Ingelheim Investigational Site
Kolding
Boehringer Ingelheim Investigational Site
Odense

Other trials in Denmark

Poland3 sites

Boehringer Ingelheim Investigational Site
Gdansk
Boehringer Ingelheim Investigational Site
Lodz
Boehringer Ingelheim Investigational Site
Starachowice

Other trials in Poland

Portugal3 sites

Boehringer Ingelheim Investigational Site
Coimbra
Boehringer Ingelheim Investigational Site
Lisbon
Boehringer Ingelheim Investigational Site
Porto

Other trials in Portugal

United Kingdom3 sites

Boehringer Ingelheim Investigational Site
Leicester
Boehringer Ingelheim Investigational Site
Norwich
Boehringer Ingelheim Investigational Site
Sheffield

Other trials in United Kingdom

Australia2 sites

Boehringer Ingelheim Investigational Site
Daw Park, South Australia
Boehringer Ingelheim Investigational Site
Glen Osmond, South Australia

Other trials in Australia

Austria1 site

Boehringer Ingelheim Investigational Site
Salzburg

Other trials in Austria

New Zealand1 site

Boehringer Ingelheim Investigational Site
Greenlane East Auckland NZ

Other trials in New Zealand

About this study

Official title: An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: placebo to tiotropium + olodaterol, tiotropium+olodaterol, tiotropium +olodaterol, tiotropium
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.

placebo to tiotropium + olodaterolDrug
comparator
tiotropium+olodaterolDrug
tiotropium 5 mcg once daily
tiotropium +olodaterolDrug
olodaterol 5 mcg once daily fixed dose combination
tiotropiumDrug
tiotropium 5 mcg once daily fixed dose combination

Study groups in NCT02085161
Study group	Role	What they receive
placebo	Placebo comparator	patient will receive placebo once daily, 2 puffs in the morning Receives: Drug: placebo to tiotropium + olodaterol
tiotropium + olodaterol high dose with BM	Experimental	patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning Receives: Drug: tiotropium +olodaterol
tiotropium	Active comparator	patient will receive tiotropium 5 mcg once daily, 2 puffs in the morning Receives: Drug: tiotropium
tiotropium + olodaterol with exercise training and BM	Experimental	patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning Receives: Drug: tiotropium+olodaterol

What is being measured

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

Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks
Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.
Measured: Week 8

Secondary outcomes (7)

Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12
Average daily walking time measured by the activity monitor in the week prior to Week 12.
Measured: Week 12
Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment
Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment. The Movement Intensity (MI) is derived from the acceleration signals. Since seismic sensors measure gravitational acceleration (g) in static situations, the acceleration signal is expressed relative to g (1g = 9.81m/s2). To calculate movement intensity (MI) the gravitational acceleration in static situations was removed and the rotation vector of the three accelerometer signals was calculated. The MI gives an indication of the power of movements.
Measured: Week 12
Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12
Perceived difficulties as evaluated with FPI-SF. FPI-SF self-report questionnaire has 6 domains: Body care(5 items), Household maintenance(8 items), Physical exercise(5 items), Recreation(5 items), Spiritual activities(4 items) and Social interaction(5 items) with five possible answers on each item: Do with no difficulty - 3, Do with some difficulty - 2, Do with great difficulty - 1, don't do because of health reasons - 0, and don't do because choose not to - 0. Domain scores are expressed as mean values, with at least 6 non-missing items required for the household maintenance domain and at least 3 non-missing items for the other domains. Total score is the mean across the six domains. So total and domain scores range from 0 to 3, with higher scores indicating higher levels of functional activity within and across domains. Respondents engaged in many activities with no difficulty will score high on the FPI, while those who perform few activities with much difficulty will score low.
Measured: Week 12
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks
Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of maximum oxygen consumption (VO2 peak) after 12 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then the ANCOVA was fitted to the log10-transformed data and the least square means and SE were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.
Measured: Week 12
One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment
One hour, Post-dose Forced Expiratory Volume in One Second (FEV1) after 8 weeks of treatment.
Measured: Week 8
One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment
One hour, Post-dose Forced Vital Capacity (FVC) after 8 weeks of treatment.
Measured: Week 8
Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment
Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment.
Measured: Week 8

Timeline

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

Mar 2014Oct 2015

First posted12 Mar 2014 (estimated)
Study startMar 2014
Primary completionAug 2015
Study completionOct 2015

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 (2)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: Parallel groups
Masking: Single blind
Enrolment: 304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02085161
Sponsor's protocol ID: 1237.16
Other IDs: 2013-002671-18
Status last verified: Nov 2016
First submitted: 7 Mar 2014
Last updated: 6 Jan 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

Troosters T, Bourbeau J, Maltais F, Leidy N, Erzen D, De Sousa D, Korducki L, Hamilton A. Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design. BMJ Open. 2016 Apr 13;6(4):e010106. doi: 10.1136/bmjopen-2015-010106.
PubMed 27075841
Bourbeau J, Lavoie KL, Sedeno M, De Sousa D, Erzen D, Hamilton A, Maltais F, Troosters T, Leidy N. Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation. BMJ Open. 2016 Apr 4;6(4):e010109. doi: 10.1136/bmjopen-2015-010109.
PubMed 27044576

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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The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT02085161
Acronym / sponsor ID: 1237.16
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 304 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Mar 2014
Primary completion: Aug 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 12 Mar 2014 (estimated)
Results: Posted 6 Jan 2017

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: Parallel groups
Masking: Single blind
Number of arms: 4

Arm	Type	Receives
placebo	Placebo comparator	Drug: placebo to tiotropium + olodaterolpatient will receive placebo once daily, 2 puffs in the morning
tiotropium + olodaterol high dose with BM	Experimental	Drug: tiotropium +olodaterolpatient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning
tiotropium	Active comparator	Drug: tiotropiumpatient will receive tiotropium 5 mcg once daily, 2 puffs in the morning
tiotropium + olodaterol with exercise training and BM	Experimental	Drug: tiotropium+olodaterolpatient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning

Who may qualify

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

Key inclusion criteria (4 listed)

All patients must sign an informed consent consistent with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (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 forced expiratory volume in one second >=30% and <80% of predicted normal; Global Initiative for Chronic Obstructive Lung Disease grade II - III, and a post-bronchodilator Tiffeneau index <70% at Visit 1.
Male or female patients, aged >=40 years and <=75 years.
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.

Key exclusion criteria (26 listed)

Patients with a significant disease other than chronic obstructive pulmonary disease.
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis.
Patients with a history of asthma.
A diagnosis of thyrotoxicosis.
A diagnosis of paroxysmal tachycardia (>100 beats per minute).

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
placebo to tiotropium + olodaterolcomparator	Drug	placebo
tiotropium+olodateroltiotropium 5 mcg once daily	Drug	tiotropium + olodaterol with exercise training and BM
tiotropium +olodaterololodaterol 5 mcg once daily fixed dose combination	Drug	tiotropium + olodaterol high dose with BM
tiotropiumtiotropium 5 mcg once daily fixed dose combination	Drug	tiotropium

Primary outcome

Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks
Time frame: Week 8
Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.

7 secondary outcomes

Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12
Time frame: Week 12
Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment
Time frame: Week 12
Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12
Time frame: Week 12
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks
Time frame: Week 12
One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment
Time frame: Week 8
One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment
Time frame: Week 8
Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment
Time frame: Week 8

Results and safety

Results posted to the registry on 6 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo With Behavioural Modification (BM)	76	64
Tiotropium (Tio) 5 Micro-grams (μg) With BM	76	66
Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM	76	71
Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM	76	66

Primary outcome: Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks

Time frame: Week 8. Geometric mean (Standard Error). Unit: Second

Measure	Placebo With Behavioural Modification (BM) n = 65	Tiotropium (Tio) 5 Micro-grams (μg) With BM n = 67	Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM n = 72	Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM n = 70
Value	244.07 (17.666)	254.18 (18.099)	315.32 (21.671)	355.73 (24.787)

Placebo With Behavioural Modification (BM) vs Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM: Treatment ratio: 1.458 (95% CI 1.196 to 1.777), p = 0.0002, ANCOVA
Placebo With Behavioural Modification (BM) vs Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM: Treatment ratio: 1.292 (95% CI 1.061 to 1.573), p = 0.0109, ANCOVA
Placebo With Behavioural Modification (BM) vs Tiotropium (Tio) 5 Micro-grams (μg) With BM: Treatment ratio: 1.041 (95% CI 0.853 to 1.272), p = 0.6895, ANCOVA

Population analysed: Full analysis set (FAS): This patient set included all patients in the Treated set (TS) who had baseline measurement and at least 1 post-baseline measurement for the primary endpoint. Patients were assigned to the FAS after implementation of any data handling rules that set measurements to missing. Patients with available data were included.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study medication up to a period of 21 days after the last dose of study medication were assigned to the treatment period, up to 134 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo With Behavioural Modification (BM)	4 of 75 (5.3%)	22 of 75 (29.3%)	Not reported
Tiotropium (Tio) 5 Micro-grams (μg) With BM	11 of 76 (14.5%)	19 of 76 (25%)	Not reported
Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM	3 of 76 (3.9%)	16 of 76 (21.1%)	Not reported
Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM	8 of 76 (10.5%)	19 of 76 (25%)	Not reported
Total	26 of 303 (8.6%)	76 of 303 (25.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27075841Troosters T, Bourbeau J, Maltais F, Leidy N, Erzen D, De Sousa D, Korducki L, Hamilton A. Enhancing exercise tolerance and physical activity in COPD with combined pharmacological and non-pharmacological interventions: PHYSACTO randomised, placebo-controlled study design. BMJ Open. 2016 Apr 13;6(4):e010106. doi: 10.1136/bmjopen-2015-010106.
Derived from this study: PubMed 27044576Bourbeau J, Lavoie KL, Sedeno M, De Sousa D, Erzen D, Hamilton A, Maltais F, Troosters T, Leidy N. Behaviour-change intervention in a multicentre, randomised, placebo-controlled COPD study: methodological considerations and implementation. BMJ Open. 2016 Apr 4;6(4):e010109. doi: 10.1136/bmjopen-2015-010109.
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

34 sites in 11 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 +olodaterol and tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 34 sites in 11 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 4 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Germany, United States, Belgium, Canada, Denmark and 6 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 6 Jan 2017). 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?

Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks (time frame: Week 8). 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 NCT02085161, which also lists 2 linked publications.

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 6 Jan 2017.