Pulmonary Disease, Chronic ObstructivePhase 2NCT01809262
Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
A Phase 2 study testing single dose of 5 mcg, single dose of 40 mcg and single dose of 20 mcg in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in Netherlands.
Trial summary
Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. 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?
- single dose of 5 mcg, single dose of 40 mcg and single dose of 20 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2005to Nov 2006
- 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
- Diagnosis of chronic obstructive pulmonary disease
- Smoking history of more than 10-pack years
Who cannot join
- History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias
- Marked baseline prolongation of QT/QTc interval
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Preliminary Dose-ranging and Safety in Patients With COPD
Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- single dose of 5 mcg, single dose of placebo, single dose of 40 mcg, single dose of 20 mcg, single dose of 2 mcg
- 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.
single dose of 5 mcgDrug
solution for inhalation
single dose of placeboDrug
solution for inhalation
single dose of 40 mcgDrug
solution for inhalation
single dose of 20 mcgDrug
solution for inhalation
single dose of 2 mcgDrug
solution for inhalation
single dose of 10 mcgDrug
solution for inhalation
| Study group | Role | What they receive |
|---|---|---|
| olodaterol 2 mcg | Experimental | solution for inhalation Receives: Drug: single dose of 2 mcg |
| olodaterol 5 mcg | Experimental | solution for inhalation Receives: Drug: single dose of 5 mcg |
| olodaterol 10 mcg | Experimental | solution for inhalation Receives: Drug: single dose of 10 mcg |
| olodaterol 20 mcg | Experimental | solution for inhalation Receives: Drug: single dose of 20 mcg |
| olodaterol 40 mcg | Experimental | solution for inhalation Receives: Drug: single dose of 40 mcg |
| placebo | Placebo comparator | solution for inhalation Receives: Drug: single dose of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment
Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.
Measured: 24 hours post-dosing
Secondary outcomes (11)
FEV1 AUC 0 - 3 Hours
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Measured: -10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing
FEV1 AUC 0 - 12 Hours
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Measured: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing
FEV1 AUC 0 - 24 Hours
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Measured: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing
FEV1 AUC 12 - 24 Hours
The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres. The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
Measured: 12h, 14h, 22h, 23h and 24h post-dosing
Peak FEV1 From 0 to 3 Hours
Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.
Measured: 0 to 3 hours post-dosing
Peak Forced Vital Capacity (FVC) From 0 to 3 Hours
Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.
Measured: 0 to 3 hours post-dosing
Time to Peak Bronchodilator Response
A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.
Measured: 0 to 3 hours post-dosing
Time to Onset of Response
Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation). If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.
Measured: 0 to 3 hours post-dosing
Number of Patients Requiring Rescue Medication on a Test-day
Number of Patients Requiring Rescue Medication on a Test-day. Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication. Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.
Measured: Visits 1,2,4,5,6
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).
Measured: 2 weeks
Laboratory Testing: Average Change From Baseline of Potassium and Calcium
Laboratory testing: Average change from baseline of potassium and calcium measured on test-days
Measured: Baseline and Visit 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startDec 2005
- Primary completionNov 2006
- Study completionNov 2006
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.
- 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
- 36 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
- NCT01809262
- Sponsor's protocol ID
- 1222.3
- Status last verified
- May 2014
- First submitted
- 8 Mar 2013
- Last updated
- 30 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Preliminary Dose-ranging and Safety in Patients With COPD
- ClinicalTrials.gov ID
- NCT01809262
- Acronym / sponsor ID
- 1222.3
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 12 Mar 2013 (estimated)
- Results
- Posted 30 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| olodaterol 2 mcg | Experimental | Drug: single dose of 2 mcgsolution for inhalation |
| olodaterol 5 mcg | Experimental | Drug: single dose of 5 mcgsolution for inhalation |
| olodaterol 10 mcg | Experimental | Drug: single dose of 10 mcgsolution for inhalation |
| olodaterol 20 mcg | Experimental | Drug: single dose of 20 mcgsolution for inhalation |
| olodaterol 40 mcg | Experimental | Drug: single dose of 40 mcgsolution for inhalation |
| placebo | Placebo comparator | Drug: single dose of placebosolution for inhalation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic obstructive pulmonary disease
- Smoking history of more than 10-pack years
Key exclusion criteria (2 listed)
- History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias
- Marked baseline prolongation of QT/QTc interval
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 |
|---|---|---|
| single dose of 5 mcgsolution for inhalation | Drug | olodaterol 5 mcg |
| single dose of placebosolution for inhalation | Drug | placebo |
| single dose of 40 mcgsolution for inhalation | Drug | olodaterol 40 mcg |
| single dose of 20 mcgsolution for inhalation | Drug | olodaterol 20 mcg |
| single dose of 2 mcgsolution for inhalation | Drug | olodaterol 2 mcg |
| single dose of 10 mcgsolution for inhalation | Drug | olodaterol 10 mcg |
Primary outcome
Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment
Time frame: 24 hours post-dosing
Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.
11 secondary outcomes
FEV1 AUC 0 - 3 Hours
Time frame: -10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing
FEV1 AUC 0 - 12 Hours
Time frame: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing
FEV1 AUC 0 - 24 Hours
Time frame: -10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing
FEV1 AUC 12 - 24 Hours
Time frame: 12h, 14h, 22h, 23h and 24h post-dosing
Peak FEV1 From 0 to 3 Hours
Time frame: 0 to 3 hours post-dosing
Peak Forced Vital Capacity (FVC) From 0 to 3 Hours
Time frame: 0 to 3 hours post-dosing
Time to Peak Bronchodilator Response
Time frame: 0 to 3 hours post-dosing
Time to Onset of Response
Time frame: 0 to 3 hours post-dosing
Number of Patients Requiring Rescue Medication on a Test-day
Time frame: Visits 1,2,4,5,6
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Time frame: 2 weeks
Laboratory Testing: Average Change From Baseline of Potassium and Calcium
Time frame: Baseline and Visit 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing single dose of 5 mcg, single dose of 40 mcg and single dose of 20 mcg in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 1 site in Netherlands.
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 2 inclusion and 2 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 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 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 30 Jun 2014). 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?
Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment (time frame: 24 hours post-dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2014.