Pulmonary Disease, Chronic ObstructivePhase 2NCT01040403
Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing olodaterol (BI 1744) low, low tiotropium bromide and olodaterol (BI 1744) high in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 33 sites in 4 countries.
Trial summary
The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- olodaterol (BI 1744) low, low tiotropium bromide and olodaterol (BI 1744) high
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 233 participants
- Where
- 33 sitesin 4 countries
- Study dates
- Jan 2010to Feb 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must sign an informed consent
- All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) must meet the following spirometric criteria:
- a post-bronchodilator forced expiratory flow in 1 second (FEV1) =<30% of predicted normal and <80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC) <70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. 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;
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
- Patients with a history of asthma or a total blood eosinophil count >=600/mm3.
- 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 - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- Patients who have undergone thoracotomy with pulmonary resection
Show all 9Show fewer
- Patients being treated with the following concomitant medications:
- medications that prolong the QT/QTc interval oral Beta-adrenergics 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
- Pregnant or nursing women
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
Germany12 sites
1237.18.49009 Boehringer Ingelheim Investigational Site
Aschaffenburg
1237.18.49012 Boehringer Ingelheim Investigational Site
Bamberg
1237.18.49005 Boehringer Ingelheim Investigational Site
Berlin
1237.18.49004 Boehringer Ingelheim Investigational Site
Frankfurt
1237.18.49011 Boehringer Ingelheim Investigational Site
Hamburg
1237.18.49010 Boehringer Ingelheim Investigational Site
Koblenz
1237.18.49007 Boehringer Ingelheim Investigational Site
Mannheim
1237.18.49001 Boehringer Ingelheim Investigational Site
Potsdam
1237.18.49006 Boehringer Ingelheim Investigational Site
Rodgau-Dudenhofen
1237.18.49002 Boehringer Ingelheim Investigational Site
Rüdersdorf
1237.18.49003 Boehringer Ingelheim Investigational Site
Weinheim
1237.18.49008 Boehringer Ingelheim Investigational Site
Wiesloch
Canada9 sites
1237.18.02005 Boehringer Ingelheim Investigational Site
Grimsby, Ontario
1237.18.02001 Boehringer Ingelheim Investigational Site
Mississauga, Ontario
1237.18.02002 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1237.18.02003 Boehringer Ingelheim Investigational Site
Point Claire, Quebec
1237.18.02009 Boehringer Ingelheim Investigational Site
Québec, Quebec
1237.18.02011 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
1237.18.02007 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
1237.18.02008 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1237.18.02004 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
Netherlands8 sites
1237.18.31004 Boehringer Ingelheim Investigational Site
Almelo
1237.18.31006 Boehringer Ingelheim Investigational Site
Amsterdam
1237.18.31008 Boehringer Ingelheim Investigational Site
Eindhoven
1237.18.31001 Boehringer Ingelheim Investigational Site
Groningen
1237.18.31007 Boehringer Ingelheim Investigational Site
Hengelo
1237.18.31005 Boehringer Ingelheim Investigational Site
Hoorn
1237.18.31002 Boehringer Ingelheim Investigational Site
Veldhoven
1237.18.31003 Boehringer Ingelheim Investigational Site
Zutphen
Sweden4 sites
1237.18.46003 Boehringer Ingelheim Investigational Site
Boden
1237.18.46002 Boehringer Ingelheim Investigational Site
Gothenburg
1237.18.46001 Boehringer Ingelheim Investigational Site
Lund
1237.18.46004 Boehringer Ingelheim Investigational Site
Stockholm
About this study
Official title: A Randomised, Double-blind, 8 Treatments, 4 Periods, Incomplete Crossover Study to Determine the Optimal Free Dose Combination of BI 1744 CL and Tiotropium Bromide (Both Delivered by the Respimat® Inhaler) After 4 Weeks Once Daily Treatment in Patients With COPD
The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- olodaterol (BI 1744) low, low tiotropium bromide, olodaterol (BI 1744) high, medium tiotropium bromide, high tiotropium bromide
- 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.
olodaterol (BI 1744) lowDrug
olodaterol (BI 1744) low
low tiotropium bromideDrug
low tiotropium bromide
olodaterol (BI 1744) highDrug
olodaterol (BI 1744) high
medium tiotropium bromideDrug
medium tiotropium bromide
high tiotropium bromideDrug
high tiotropium bromide
PlaceboDrug
Placebo
RespimatDevice
Respimat inhaler
| Study group | Role | What they receive |
|---|---|---|
| olodaterol (BI 1744) low and placebo | Experimental | low dose inhaled olodaterol orally once daily from the Respimat inhaler Receives: Drug: olodaterol (BI 1744) low; Drug: Placebo; Device: Respimat |
| olodaterol (BI 1744) low and low tio | Experimental | low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily Receives: Drug: olodaterol (BI 1744) low; Drug: low tiotropium bromide; Device: Respimat |
| olodaterol (BI 1744) low and medium tio | Experimental | low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily Receives: Drug: olodaterol (BI 1744) low; Drug: medium tiotropium bromide; Device: Respimat |
| olodaterol (BI 1744) low and high tio | Experimental | low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily Receives: Drug: olodaterol (BI 1744) low; Drug: high tiotropium bromide; Device: Respimat |
| olodaterol (BI 1744) high and placebo | Experimental | high dose inhaled olodaterol orally once daily from the Respimat inhaler Receives: Drug: olodaterol (BI 1744) high; Drug: Placebo; Device: Respimat |
| Olodaterol (BI 1744) high and low tio | Experimental | high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily Receives: Drug: low tiotropium bromide; Drug: olodaterol (BI 1744) high; Device: Respimat |
| Olodaterol (BI 1744) high and medium tio | Experimental | high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily Receives: Drug: olodaterol (BI 1744) high; Drug: medium tiotropium bromide; Device: Respimat |
| Olodaterol (BI 1744) high and high tio | Experimental | high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily Receives: Drug: olodaterol (BI 1744) high; Drug: high tiotropium bromide; Device: Respimat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 Response
Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29
Secondary outcomes (21)
Trough Forced Vital Capacity (FVC) Response
Adjusted means of trough FVC (forced vital capacity) response [L] after 4 weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29
FEV1 AUC 0-3h and FEV1 AUC 0-6h Response
Adjusted means of forced expiratory volume in one second (FEV1) area under the curve (AUC) 0-3 hour and AUC 0-6 hour responses [L] after 4 weeks treatment calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29
FEV1 AUC 0-3h Response After the First Dose
Adjusted means of Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-3h response [L] after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1
FEV1 Peak 0-3h Response
Adjusted means of the FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29
FEV1 Peak 0-3h Response After the First Dose
Adjusted means of the FEV1 peak 0-3h response [L] after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1
FVC AUC 0-3h and FEV1 AUC 0-6h Responses
Adjusted means of the FVC AUC 0-3h and AUC 0-6h responses [L] after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29
FVC AUC 0-3h Response After First Dose
Adjusted means of the FVC AUC 0-3h response [L] after first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1
FVC Peak 0-3h Response
Adjusted means of the FVC peak 0-3h response [L] after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29
FVC Peak 0-3h Response After the First Dose
Adjusted mean of the FVC peak 0-3h response [L] after the first dose. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1
PEF AUC 0-3h and AUC 0-6h Responses
Adjusted means of the Peak Expiratory Flow (PEF) AUC 0-3h and AUC 0-6h responses in Litres / minute (L/min) after 4 weeks of treatment, calculated using the trapezoidal rule, divided by the duration (3 h, 6 h) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29
PEF AUC 0-3h Response After the First Dose
Adjusted means of the Area under the curve from 0 to 3 h response in Litres / minutes of the peak expiratory flow after the first dose, calculated using the trapezoidal rule, divided by the duration (3 hours) to report in litres. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1
PEF Peak 0-3h Response
Adjusted means of the peak expiratory flow from 0 to 3 hours (PEF peak 0-3h) response in L/min after 4 weeks of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29
PEF Peak 0-3h Response After the First Dose
Adjusted means of the Peak Expiratory flow from 0 to 3 hours response in L/min after the first dose of treatment. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1
Individual FEV1 Measurements at Each Time Point on Day 29
Adjusted means of the FEV1 measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29
Individual FVC Measurements at Each Time Point on Day 29
Adjusted means of the FVC measurements [L] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29
Individual PEF Measurements at Each Time Point on Day 29
Adjusted means of the PEF measurements [L/min] at each time point on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
Measured: Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29
Weekly Mean Number of Puffs of Rescue Medication Used Per Day
Adjusted means of the weekly mean number of puffs of rescue medication during the whole day : the rescue medication was a salbutamol [albuterol] dose (100 mcg per puff).
Measured: Weeks 1 and 4
Physicians Global Evaluation
Adjusted means of the Physicians Global Evaluation of the patient's respiratory condition on days 1 and 29.
The score was evaluated on a 8-points scale :
- Poor : 1,2
- Fair : 3,4
- Good : 5,6
- Excellent : 7,8
Measured: Days 1 and 29
Patients Global Rating
Adjusted means of the Global Rating of the patients' health (respiratory condition) on day 29.
The score was evaluated on a 7-point scale :
- 1 : very much better
- 2 : much better
- 3 : a little better
- 4 : no change
- 5 : a little worse
- 6 : much worse
- 7 : very much worse
Measured: Day 29
Pulse Rate Recorded in Conjunction With Spirometry
Pulse rate recorded in conjunction with spirometry change from baseline at 30 minutes post-dose on day 29 in beats per minute (bpm).
Measured: Baseline and 30 min post-dose on day 29
Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry
Systolic and diastolic blood pressure recorded in conjunction with spirometry change from baseline on day 29 in millimetres of mercury (mmHg).
Measured: Baseline and 30 min post-dose on day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionFeb 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040403
- Sponsor's protocol ID
- 1237.18
- Other IDs
- 2009-014880-38, 2009
- Status last verified
- Jun 2015
- First submitted
- 28 Dec 2009
- Last updated
- 15 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Aalbers R, Maleki-Yazdi MR, Hamilton A, Waitere-Wijker S, Zhao Y, Amatto VC, Schmidt O, Bjermer L. Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat(R) Inhaler in Patients with Chronic Obstructive Pulmonary Disease. Adv Ther. 2015 Sep;32(9):809-22. doi: 10.1007/s12325-015-0239-8. Epub 2015 Sep 24.
PubMed 26404912
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, 8 Treatments, 4 Periods, Incomplete Crossover Study to Determine the Optimal Free Dose Combination of BI 1744 CL and Tiotropium Bromide (Both Delivered by the Respimat® Inhaler) After 4 Weeks Once Daily Treatment in Patients With COPD
- ClinicalTrials.gov ID
- NCT01040403
- Acronym / sponsor ID
- 1237.18
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Feb 2011 (actual)
- First posted
- 29 Dec 2009 (estimated)
- Results
- Posted 15 Jul 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 determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| olodaterol (BI 1744) low and placebo | Experimental | Drug: olodaterol (BI 1744) low, Drug: Placebo, Device: Respimatlow dose inhaled olodaterol orally once daily from the Respimat inhaler |
| olodaterol (BI 1744) low and low tio | Experimental | Drug: olodaterol (BI 1744) low, Drug: low tiotropium bromide, Device: Respimatlow dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily |
| olodaterol (BI 1744) low and medium tio | Experimental | Drug: olodaterol (BI 1744) low, Drug: medium tiotropium bromide, Device: Respimatlow dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily |
| olodaterol (BI 1744) low and high tio | Experimental | Drug: olodaterol (BI 1744) low, Drug: high tiotropium bromide, Device: Respimatlow dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily |
| olodaterol (BI 1744) high and placebo | Experimental | Drug: olodaterol (BI 1744) high, Drug: Placebo, Device: Respimathigh dose inhaled olodaterol orally once daily from the Respimat inhaler |
| Olodaterol (BI 1744) high and low tio | Experimental | Drug: low tiotropium bromide, Drug: olodaterol (BI 1744) high, Device: Respimathigh dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily |
| Olodaterol (BI 1744) high and medium tio | Experimental | Drug: olodaterol (BI 1744) high, Drug: medium tiotropium bromide, Device: Respimathigh dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily |
| Olodaterol (BI 1744) high and high tio | Experimental | Drug: olodaterol (BI 1744) high, Drug: high tiotropium bromide, Device: Respimathigh dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients must sign an informed consent
- All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) must meet the following spirometric criteria:
- a post-bronchodilator forced expiratory flow in 1 second (FEV1) =<30% of predicted normal and <80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC) <70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack years
Key exclusion criteria (9 listed)
- Patients with a significant disease other than COPD;
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
- Patients with a history of asthma or a total blood eosinophil count >=600/mm3.
- 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 - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
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 |
|---|---|---|
| olodaterol (BI 1744) lowolodaterol (BI 1744) low | Drug | olodaterol (BI 1744) low and high tio, olodaterol (BI 1744) low and low tio, olodaterol (BI 1744) low and medium tio, olodaterol (BI 1744) low and placebo |
| low tiotropium bromidelow tiotropium bromide | Drug | Olodaterol (BI 1744) high and low tio, olodaterol (BI 1744) low and low tio |
| olodaterol (BI 1744) higholodaterol (BI 1744) high | Drug | Olodaterol (BI 1744) high and high tio, Olodaterol (BI 1744) high and low tio, Olodaterol (BI 1744) high and medium tio, olodaterol (BI 1744) high and placebo |
| medium tiotropium bromidemedium tiotropium bromide | Drug | Olodaterol (BI 1744) high and medium tio, olodaterol (BI 1744) low and medium tio |
| high tiotropium bromidehigh tiotropium bromide | Drug | Olodaterol (BI 1744) high and high tio, olodaterol (BI 1744) low and high tio |
| PlaceboPlacebo | Drug | olodaterol (BI 1744) high and placebo, olodaterol (BI 1744) low and placebo |
| RespimatRespimat inhaler | Device | Olodaterol (BI 1744) high and high tio, Olodaterol (BI 1744) high and low tio, Olodaterol (BI 1744) high and medium tio, olodaterol (BI 1744) high and placebo, olodaterol (BI 1744) low and high tio, olodaterol (BI 1744) low and low tio, olodaterol (BI 1744) low and medium tio, olodaterol (BI 1744) low and placebo |
Primary outcome
Trough FEV1 Response
Time frame: Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29
Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.
21 secondary outcomes
Trough Forced Vital Capacity (FVC) Response
Time frame: Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29
FEV1 AUC 0-3h and FEV1 AUC 0-6h Response
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29
FEV1 AUC 0-3h Response After the First Dose
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1
FEV1 Peak 0-3h Response
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29
FEV1 Peak 0-3h Response After the First Dose
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1
FVC AUC 0-3h and FEV1 AUC 0-6h Responses
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29
FVC AUC 0-3h Response After First Dose
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on days 1
FVC Peak 0-3h Response
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29
FVC Peak 0-3h Response After the First Dose
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1
PEF AUC 0-3h and AUC 0-6h Responses
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29
PEF AUC 0-3h Response After the First Dose
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1
PEF Peak 0-3h Response
Time frame: Baseline 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29
PEF Peak 0-3h Response After the First Dose
Time frame: Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1
Individual FEV1 Measurements at Each Time Point on Day 29
Time frame: Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29
Individual FVC Measurements at Each Time Point on Day 29
Time frame: Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29
Individual PEF Measurements at Each Time Point on Day 29
Time frame: Baseline and 1 h, 10 min pre-dose and 0 min, 5 min, 30 min, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h post-dose on day 29
Weekly Mean Number of Puffs of Rescue Medication Used Per Day
Time frame: Weeks 1 and 4
Physicians Global Evaluation
Time frame: Days 1 and 29
Patients Global Rating
Time frame: Day 29
Pulse Rate Recorded in Conjunction With Spirometry
Time frame: Baseline and 30 min post-dose on day 29
Systolic and Diastolic Blood Pressure Recorded in Conjunction With Spirometry
Time frame: Baseline and 30 min post-dose on day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26404912Aalbers R, Maleki-Yazdi MR, Hamilton A, Waitere-Wijker S, Zhao Y, Amatto VC, Schmidt O, Bjermer L. Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat(R) Inhaler in Patients with Chronic Obstructive Pulmonary Disease. Adv Ther. 2015 Sep;32(9):809-22. doi: 10.1007/s12325-015-0239-8. Epub 2015 Sep 24.
- 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 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing olodaterol (BI 1744) low, low tiotropium bromide and olodaterol (BI 1744) high in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 33 sites in 4 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 3 inclusion and 9 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 Jul 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 Germany, Canada, Netherlands, Sweden. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jul 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?
Trough FEV1 Response (time frame: Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29). 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 NCT01040403, 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 Jul 2015.