Pulmonary Disease, Chronic ObstructivePhase 3NCT01525615
A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Rate Cycle Ergometry Test in COPD
A Phase 3 study testing Respimat inhaler, tiotropium+olodaterol (low dose) and tiotropium + olodaterol (high dose) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 60 sites in 10 countries.
Trial summary
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment 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?
- Respimat inhaler, tiotropium+olodaterol (low dose) and tiotropium + olodaterol (high dose)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 404 participants
- Where
- 60 sitesin 10 countries
- Study dates
- Feb 2012to Sep 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, at visit 1:
- a post-bronchodilator 30% <= FEV1 <80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1
- Male or female patients, between 40 and 75 years (inclusive) of age on day of signing informed consent.
- 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.
- Patients must be able to perform technically acceptable pulmonary function tests (spirometry), must be able to complete multiple symptom-limited cycle ergometry tests (and for a subset also shuttle walk tests), as required in the protocol.
- Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).
Who cannot join
- Patients with a significant disease other than COPD
- 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
- A diagnosis of thyrotoxicosis
- A diagnosis of paroxysmal tachycardia (>100 beats per minute)
- A history of myocardial infarction within 1 year of screening visit (Visit 1)
Show all 32Show 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 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 (Visit 1) 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 or morbid obesity
- Patients with an endurance time >=25 minutes during the training (Visit 2) or baseline (Visit 3) constant work rate cycle ergometry
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1)
- Patients with known hypersensitivity to ß-adrenergic 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 a highly effective method of birth control.
- Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
- Patients who have previously been randomized in this study or are currently participating in another study
- Patients who are unable to comply with pulmonary medication restrictions prior to randomization
- At sites performing the shuttle walk tests, patients with the following criteria will be excluded from the shuttle walk tests:
- Patients who complete level 12 at the incremental shuttle walk test at visit 1a.
- Patients with an endurance time >=15 minutes during the training (Visit 2a) or baseline (visit 3a) endurance shuttle walk test.
Trial locations and contacts
60 sites in 10 countries.
60 sites in 10 countries
United States15 sites
1237.15.01513 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1237.15.01508 Boehringer Ingelheim Investigational Site
Easley, South Carolina
1237.15.01501 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1237.15.01512 Boehringer Ingelheim Investigational Site
Hartford, Connecticut
1237.15.01507 Boehringer Ingelheim Investigational Site
Iowa City, Iowa
1237.15.01509 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire
1237.15.01504 Boehringer Ingelheim Investigational Site
Livonia, Michigan
1237.15.01514 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1237.15.01516 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1237.15.01510 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1237.15.01511 Boehringer Ingelheim Investigational Site
Saint Charles, Missouri
1237.15.01505 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
1237.15.01506 Boehringer Ingelheim Investigational Site
Springfield, Illinois
1237.15.01503 Boehringer Ingelheim Investigational Site
Torrance, California
1237.15.01502 Boehringer Ingelheim Investigational Site
Union, South Carolina
Germany8 sites
1237.15.49507 Boehringer Ingelheim Investigational Site
Aschaffenburg
1237.15.49502 Boehringer Ingelheim Investigational Site
Berlin
1237.15.49504 Boehringer Ingelheim Investigational Site
Berlin
1237.15.49501 Boehringer Ingelheim Investigational Site
Großhansdorf
1237.15.49509 Boehringer Ingelheim Investigational Site
Hamburg
1237.15.49505 Boehringer Ingelheim Investigational Site
Hanover
1237.15.49508 Boehringer Ingelheim Investigational Site
Koblenz
1237.15.49506 Boehringer Ingelheim Investigational Site
Wiesloch
Italy8 sites
1237.15.39512 Boehringer Ingelheim Investigational Site
Ferrara
1237.15.39504 Boehringer Ingelheim Investigational Site
Parma
1237.15.39503 Boehringer Ingelheim Investigational Site
Pavia
1237.15.39501 Boehringer Ingelheim Investigational Site
Pisa
1237.15.39509 Boehringer Ingelheim Investigational Site
Pisa
1237.15.39511 Boehringer Ingelheim Investigational Site
Roma
1237.15.39508 Boehringer Ingelheim Investigational Site
Sesto San Giovanni (MI)
1237.15.39506 Boehringer Ingelheim Investigational Site
Trieste
United Kingdom6 sites
1237.15.44152 Boehringer Ingelheim Investigational Site
Leicester
1237.15.44154 Boehringer Ingelheim Investigational Site
Liverpool
1237.15.44153 Boehringer Ingelheim Investigational Site
London
1237.15.44151 Boehringer Ingelheim Investigational Site
Manchester
1237.15.44155 Boehringer Ingelheim Investigational Site
Norwich
1237.15.44158 Boehringer Ingelheim Investigational Site
Plymouth
Canada5 sites
1237.15.11501 Boehringer Ingelheim Investigational Site
Hamilotn, Ontario
1237.15.11503 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1237.15.11504 Boehringer Ingelheim Investigational Site
Kingston, Ontario
1237.15.11505 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1237.15.11502 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec
Spain5 sites
1237.15.34506 Boehringer Ingelheim Investigational Site
Alicante
1237.15.34501 Boehringer Ingelheim Investigational Site
Barakaldo (Bilbao)
1237.15.34507 Boehringer Ingelheim Investigational Site
Madrid
1237.15.34009 Boehringer Ingelheim Investigational Site
Málaga
1237.15.34001 Boehringer Ingelheim Investigational Site
Santander
Hungary4 sites
1237.15.36504 Boehringer Ingelheim Investigational Site
Budapest
1237.15.36501 Boehringer Ingelheim Investigational Site
Deszk
1237.15.36503 Boehringer Ingelheim Investigational Site
Nyíregyháza
1237.15.36502 Boehringer Ingelheim Investigational Site
Pécs
Argentina3 sites
1237.15.54502 Boehringer Ingelheim Investigational Site
Buenos Aires
1237.15.54501 Boehringer Ingelheim Investigational Site
Mendonza
1237.15.54503 Boehringer Ingelheim Investigational Site
Provincia de Buenos Aires
Finland3 sites
1237.15.35851 Boehringer Ingelheim Investigational Site
Helsinki
1237.15.35853 Boehringer Ingelheim Investigational Site
Turku
1237.15.35852 Boehringer Ingelheim Investigational Site
Vaasa
France3 sites
1237.15.33502 Boehringer Ingelheim Investigational Site
Nîmes
1237.15.33504 Boehringer Ingelheim Investigational Site
Pessac
1237.15.33501 Boehringer Ingelheim Investigational Site
Strasbourg
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Respimat inhaler, tiotropium+olodaterol (low dose), tiotropium + olodaterol (high dose), placebo to tiotropium+olodaterol
- 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.
Respimat inhalerDevice
Respimat inhaler
tiotropium+olodaterol (low dose)Drug
2.5 µg tiotropium + 5 µg olodaterol
tiotropium + olodaterol (high dose)Drug
5 µg tiotropium + 5 µg olodaterol
Respimat inhalerDevice
Respimat inhaler
Respimat inhalerDevice
Respimat inhaler
placebo to tiotropium+olodaterolDrug
comparator
| Study group | Role | What they receive |
|---|---|---|
| tiotropium+olodaterol low dose | Experimental | once daily 2 puffs, fixed dose combination (FDC) solution for inhalation Respimat Receives: Device: Respimat inhaler; Drug: tiotropium+olodaterol (low dose) |
| tiotropium+olodaterol high dose | Experimental | once daily 2 puffs, FDC solution for inhalation Respimat Receives: Drug: tiotropium + olodaterol (high dose); Device: Respimat inhaler |
| placebo | Placebo comparator | once daily 2 puffs, solution for inhalation Respimat Receives: Device: Respimat inhaler; Drug: placebo to tiotropium+olodaterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks
Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.
Measured: 12 weeks
Secondary outcomes (12)
Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 12 Weeks
Key secondary endpoint was endurance time during endurance shuttle walk test to symptom limitation at 85% of predicted maximum oxygen consumption (VO2) peak after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.
Measured: 12 weeks
Adjusted Mean Inspiratory Capacity at Pre-exercise After 12 Weeks
Secondary endpoint was pre-exercise inspiratory capacity (IC) before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 12 weeks of treatment.
Measured: 12 weeks
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) on Day 1
Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity on Day 1. Analysis of covariance model on log10 transformation data. Adjusted means are back transformed to report in original units. Standard errors (SEs) are calculated using the delta method.
Measured: 1 day
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 6 Weeks Treatment
Secondary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.
Measured: 6 weeks
Adjusted Mean Inspiratory Capacity at Pre-exercise After 1 Day
Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) on Day 1.
Measured: 1 day
Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks
Secondary endpoint was pre-exercise inspiratory capacity (IC) during constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap) after 6 weeks of treatment.
Measured: 6 weeks
Adjusted Mean Slope of the Intensity of Breathing Discomfort on Day 1
Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 1 day of treatment.
The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates slowing down in decline in breathing, i.e., favorable results.
Measured: 1 day
Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 6
Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 6 weeks of treatment.
The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results.
Measured: 6 weeks
Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 12
Secondary endpoint was the slope of the intensity of breathing discomfort during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment.
The intensity of breathing discomfort was rated on the Borg Scale with categories from 0 (nothing at all) to 10 (maximal). The slope of the intensity of breathing discomfort was defined as the Borg scale value of breathing discomfort at the end of exercise minus the Borg scale value of breathing discomfort at pre-exercise divided by the endurance time. A decrease in slope indicates favorable results.
Measured: 12 weeks
Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) on Day 1
Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed on day 1
Measured: 1 day
Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 6 Weeks
Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 6 weeks of treatment
Measured: 6 weeks
Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 12 Weeks
Secondary endpoint was adjusted mean 1-hour, post-dose Forced Expiratory Volume in one second (FEV1) observed after 12 weeks of treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionSep 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525615
- Sponsor's protocol ID
- 1237.15
- Other IDs
- 2011-004253-11
- Status last verified
- Jul 2016
- First submitted
- 1 Feb 2012
- Last updated
- 29 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Maltais F, O'Donnell D, Galdiz Iturri JB, Kirsten AM, Singh D, Hamilton A, Tetzlaff K, Zhao Y, Casaburi R. Effect of 12 weeks of once-daily tiotropium/olodaterol on exercise endurance during constant work-rate cycling and endurance shuttle walking in chronic obstructive pulmonary disease. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753465818755091. doi: 10.1177/1753465818755091.
PubMed 29439648
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg and 5/5 µg) Delivered by the Respimat® Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]
- ClinicalTrials.gov ID
- NCT01525615
- Acronym / sponsor ID
- 1237.15
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 3 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.
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tiotropium+olodaterol low dose | Experimental | Device: Respimat inhaler, Drug: tiotropium+olodaterol (low dose)once daily 2 puffs, fixed dose combination (FDC) solution for inhalation Respimat |
| tiotropium+olodaterol high dose | Experimental | Drug: tiotropium + olodaterol (high dose), Device: Respimat inhaleronce daily 2 puffs, FDC solution for inhalation Respimat |
| placebo | Placebo comparator | Device: Respimat inhaler, Drug: placebo to tiotropium+olodaterolonce daily 2 puffs, solution for inhalation Respimat |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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:
- a post-bronchodilator 30% <= FEV1 <80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1
- Male or female patients, between 40 and 75 years (inclusive) of age on day of signing informed consent.
- 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 (32 listed)
- Patients with a significant disease other than COPD
- 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
- 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 |
|---|---|---|
| Respimat inhalerRespimat inhaler | Device | tiotropium+olodaterol low dose |
| tiotropium+olodaterol (low dose)2.5 µg tiotropium + 5 µg olodaterol | Drug | tiotropium+olodaterol low dose |
| tiotropium + olodaterol (high dose)5 µg tiotropium + 5 µg olodaterol | Drug | tiotropium+olodaterol high dose |
| Respimat inhalerRespimat inhaler | Device | tiotropium+olodaterol high dose |
| Respimat inhalerRespimat inhaler | Device | placebo |
| placebo to tiotropium+olodaterolcomparator | Drug | placebo |
Primary outcome
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks
Time frame: 12 weeks
Primary endpoint was endurance time during constant work rate cycle ergometry to symptom limitation at 75% of maximal work capacity after 12 weeks of treatment. The endurance time in seconds was transformed using log10 scale to correct skewness in endurance time on original scale and then the MMRM model was fitted to the log10-transformed data and the least square means and SEs were obtained. To present the results in a way easier for interpretation, the least square mean from the MMRM fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate for the log10 of geometric mean and the corresponding SE was transformed using delta method to get the corresponding SEs of the geometric mean.
12 secondary outcomes
Adjusted Mean Endurance Time During Endurance Shuttle Walk Test (ESWT) After 12 Weeks
Time frame: 12 weeks
Adjusted Mean Inspiratory Capacity at Pre-exercise After 12 Weeks
Time frame: 12 weeks
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) on Day 1
Time frame: 1 day
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 6 Weeks Treatment
Time frame: 6 weeks
Adjusted Mean Inspiratory Capacity at Pre-exercise After 1 Day
Time frame: 1 day
Adjusted Mean Inspiratory Capacity at Pre-exercise After 6 Weeks
Time frame: 6 weeks
Adjusted Mean Slope of the Intensity of Breathing Discomfort on Day 1
Time frame: 1 day
Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 6
Time frame: 6 weeks
Adjusted Mean Slope of the Intensity of Breathing Discomfort After Week 12
Time frame: 12 weeks
Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) on Day 1
Time frame: 1 day
Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 6 Weeks
Time frame: 6 weeks
Adjusted Mean 1-hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 12 Weeks
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29439648Maltais F, O'Donnell D, Galdiz Iturri JB, Kirsten AM, Singh D, Hamilton A, Tetzlaff K, Zhao Y, Casaburi R. Effect of 12 weeks of once-daily tiotropium/olodaterol on exercise endurance during constant work-rate cycling and endurance shuttle walking in chronic obstructive pulmonary disease. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753465818755091. doi: 10.1177/1753465818755091.
- 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
60 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Respimat inhaler, tiotropium+olodaterol (low dose) and tiotropium + olodaterol (high dose) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 60 sites in 10 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 8 inclusion and 32 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 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Germany, Italy, United Kingdom, Canada and 5 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?
Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (time frame: 12 weeks). 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 NCT01525615, 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 29 Aug 2016.