AsthmaPhase 2NCT00928668

Efficacy (Bronchoprotection) and Safety of Orally Inhaled BI 1744 CL in Patients With Intermittent Asthma

A Phase 2 study testing Olodaterol (BI1744CL) in people with Asthma, run by Boehringer Ingelheim at 4 sites in Canada.

Completed

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

Trial summary

The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: Olodaterol (BI1744CL)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 4 sitesCanada
Study dates: Jan 2006to Oct 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of intermittent asthma according to Global Initiative for Asthma criteria
Non-smokers or ex-smokers who have not smoked for at least 1 year and have a smoking history of less than 5 pack-years
Forced Expiratory Volume in 1second greater than or equal to 80% predicted normal (Visit 1).
Bronchial hyperresponsiveness to inhaled methacholine with a provocative concentration of a methacholine causing a 20% fall in Forced Expiratory Volume in one second less than or equal to 8 mg/mL (Visit 1).
Be able to perform technically acceptable pulmonary function tests
Be able to inhale medication in a competent manner from the Respimat® inhaler
Must sign and date an informed consent consistent with International Conference on Harmonisation-Good Clinical Practice guidelines prior to participation in the trial, which includes medication washout and restrictions.

Who cannot join

Patients with a significant disease other than asthma
Patients with seasonal asthma or allergies whose participation in the trial will occur during the season for which they are allergic.
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with a serum glutamic oxaloacetic transaminase > 80 IU/L, serum glutamic pyruvic transaminase > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition
Patients with any of the following conditions: a diagnosis of hyperthyrosis or paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval, a history of additional risk factors for Torsade de Pointes, a history of myocardial infarction, a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, or a history of significant alcohol or drug abuse.
Patients who have undergone thoracotomy with pulmonary resection
Patients who are being treated with any of the following concomitant medications: medications that prolong the QT/QTc interval, oral beta-adrenergics, beta-blockers or monoamine oxidase inhibitors or tricyclic antidepressants.

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Patients who have been treated with any respiratory medications (excluding short-acting beta-agonists) for control of their asthma symptoms within 3 months of the Screening Visit (Visit 1).
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1).
Pregnant or nursing women, or women of childbearing potential not using a highly effective method of birth control.

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

1222.4.104 Department of Medicine, Health Sciences Centre
Hamilton, Ontario
1222.4.101 2725 Chemin Ste Foy
Sainte-Foy, Quebec
1222.4.102
Saskatoon, Saskatchewan
1222.4.103 UBC - Respiratory Medicine
Vancouver, British Columbia

Other trials in Canada

About this study

Official title: Randomised, Double-Blind, Placebo-Controlled, 5-Way Cross-Over Study to Assess the Efficacy (Bronchoprotection) and Safety of a Single Dose of Orally Inhaled BI 1744 CL (2, 5, 10 and 20ug) in Patients With Intermittent Asthma

Conditions: Asthma
Being tested: Placebo, Olodaterol (BI1744CL)
Medical subject headings: Asthma

What participants receive

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

PlaceboDrug
Placebo device for comparison
Olodaterol (BI1744CL)Drug
Olodaterol comparison of low, medium low, medium high and high doses
Olodaterol (BI1744CL)Drug
Olodaterol comparison of low, medium low, medium high and high doses
Olodaterol (BI1744CL)Drug
Olodaterol comparison of low, medium low, medium high and high doses
Olodaterol (BI1744CL)Drug
Olodaterol comparison of low, medium low, medium high and high doses

Study groups in NCT00928668
Study group	Role	What they receive
Olodaterol (BI1744) Low	Experimental	Single dosing of low dose Olodaterol inhaled orally from Respimat Device Receives: Drug: Olodaterol (BI1744CL)
Olodaterol (BI1744) Medium Low	Experimental	Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device Receives: Drug: Olodaterol (BI1744CL)
Olodaterol (BI1744) Medium High	Experimental	Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device Receives: Drug: Olodaterol (BI1744CL)
Olodaterol (BI 1744) High	Experimental	Single dosing of high dose Olodaterol inhaled orally from Respimat Device Receives: Drug: Olodaterol (BI1744CL)
Placebo	Placebo comparator	Single dosing of Olodaterol placebo inhaled orally from Respimat Device Receives: Drug: Placebo

What is being measured

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

Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours
Measured: 24 hours post dose

Secondary outcomes (6)

Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 30 minutes
Measured: 30 minutes post dose
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 4 hours
Measured: 4 hours post dose
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 8 hours
Measured: 8 hours post dose
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 32 hours
Measured: 32 hours post dose
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: 5 days
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 to Visit 6

Timeline

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

Jan 2006Oct 2006

First posted26 Jun 2009 (estimated)
Study startJan 2006
Primary completionOct 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 AsthmaStudies 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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00928668
Sponsor's protocol ID: 1222.4
Status last verified: May 2014
First submitted: 25 Jun 2009
Last updated: 1 Jul 2014
Results posted: Yes, on ClinicalTrials.gov

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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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised, Double-Blind, Placebo-Controlled, 5-Way Cross-Over Study to Assess the Efficacy (Bronchoprotection) and Safety of a Single Dose of Orally Inhaled BI 1744 CL (2, 5, 10 and 20ug) in Patients With Intermittent Asthma
ClinicalTrials.gov ID: NCT00928668
Acronym / sponsor ID: 1222.4
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Oct 2006 (actual)
First posted: 26 Jun 2009 (estimated)
Results: Posted 1 Jul 2014

Clinical summary

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

Study design

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

Arm	Type	Receives
Olodaterol (BI1744) Low	Experimental	Drug: Olodaterol (BI1744CL)Single dosing of low dose Olodaterol inhaled orally from Respimat Device
Olodaterol (BI1744) Medium Low	Experimental	Drug: Olodaterol (BI1744CL)Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device
Olodaterol (BI1744) Medium High	Experimental	Drug: Olodaterol (BI1744CL)Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device
Olodaterol (BI 1744) High	Experimental	Drug: Olodaterol (BI1744CL)Single dosing of high dose Olodaterol inhaled orally from Respimat Device
Placebo	Placebo comparator	Drug: PlaceboSingle dosing of Olodaterol placebo inhaled orally from Respimat Device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Diagnosis of intermittent asthma according to Global Initiative for Asthma criteria
Non-smokers or ex-smokers who have not smoked for at least 1 year and have a smoking history of less than 5 pack-years
Forced Expiratory Volume in 1second greater than or equal to 80% predicted normal (Visit 1).
Bronchial hyperresponsiveness to inhaled methacholine with a provocative concentration of a methacholine causing a 20% fall in Forced Expiratory Volume in one second less than or equal to 8 mg/mL (Visit 1).
Be able to perform technically acceptable pulmonary function tests

Key exclusion criteria (9 listed)

Patients with a significant disease other than asthma
Patients with seasonal asthma or allergies whose participation in the trial will occur during the season for which they are allergic.
Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with a serum glutamic oxaloacetic transaminase > 80 IU/L, serum glutamic pyruvic transaminase > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition
Patients with any of the following conditions: a diagnosis of hyperthyrosis or paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval, a history of additional risk factors for Torsade de Pointes, a history of myocardial infarction, a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (patients with treated basal cell carcinoma are allowed), a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, or a history of significant alcohol or drug abuse.
Patients who have undergone thoracotomy with pulmonary resection

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

Interventions

Intervention	Type	Arms
PlaceboPlacebo device for comparison	Drug	Placebo
Olodaterol (BI1744CL)Olodaterol comparison of low, medium low, medium high and high doses	Drug	Olodaterol (BI1744) Medium High
Olodaterol (BI1744CL)Olodaterol comparison of low, medium low, medium high and high doses	Drug	Olodaterol (BI1744) Low
Olodaterol (BI1744CL)Olodaterol comparison of low, medium low, medium high and high doses	Drug	Olodaterol (BI1744) Medium Low
Olodaterol (BI1744CL)Olodaterol comparison of low, medium low, medium high and high doses	Drug	Olodaterol (BI 1744) High

Primary outcome

Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours
Time frame: 24 hours post dose
Provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20FEV1) at 24 hours

6 secondary outcomes

Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 30 Minutes
Time frame: 30 minutes post dose
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 4 Hours
Time frame: 4 hours post dose
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 8 Hours
Time frame: 8 hours post dose
Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 32 Hours
Time frame: 32 hours post dose
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
Time frame: 5 days
Laboratory Testing: Average Change From Baseline of Potassium and Calcium
Time frame: Baseline to Visit 6

Results and safety

Results posted to the registry on 1 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg	7	6
Olo 10mcg / Olo 20mcg / Olo 2mcg / Olo 5mcg / Placebo	7	6
Olo 2mcg / Placebo / Olo 20mcg / Olo 10mcg / Olo 5mcg	7	6
Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg / Olo 10mcg	4	3
Placebo / Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg	6	5

Primary outcome: Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours

Time frame: 24 hours post dose. Least squares mean (Standard Error). Unit: Log base 2 (mg/ml)

Measure	Placebo n = 29	Olodaterol (Olo) 2 mcg qd n = 28	Olodaterol (Olo) 5 mcg qd n = 27	Olodaterol (Olo) 10 mcg qd n = 30	Olodaterol (Olo) 20 mcg qd n = 29
Value	0.793 (0.182)	1.950 (0.186)	2.504 (0.190)	3.236 (0.179)	3.777 (0.183)

Placebo vs Olodaterol (Olo) 2 mcg qd: Mean Difference (Final Values): 1.157 (95% CI 0.657 to 1.657), p <0.0001, Mixed Models Analysis
Placebo vs Olodaterol (Olo) 5 mcg qd: Mean Difference (Final Values): 1.711 (95% CI 1.205 to 2.217), p <0.0001, Mixed Models Analysis
Placebo vs Olodaterol (Olo) 10 mcg qd: Mean Difference (Final Values): 2.443 (95% CI 1.952 to 2.935), p <0.0001, Mixed Models Analysis

Population analysed: Full analysis set (FAS). FAS is defined as all patients that were randomised, received treatment and had baseline data and post-dose data for at least two periods for the same endpoint.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 29 (0%)	4 of 29 (13.8%)	Not reported
Olo 2 mcg	0 of 28 (0%)	1 of 28 (3.6%)	Not reported
Olo 5 mcg	0 of 28 (0%)	1 of 28 (3.6%)	Not reported
Olo 10 mcg	0 of 30 (0%)	1 of 30 (3.3%)	Not reported
Olo 20 mcg	0 of 29 (0%)	4 of 29 (13.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Asthma

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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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Olodaterol (BI1744CL) in people with Asthma, run by Boehringer Ingelheim at 4 sites in Canada.

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 7 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 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. 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 1 Jul 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?

Adjusted Mean of Provocative Concentration of Methacholine Required to Produce a 20% Decrease in FEV1 (PC20FEV1) at 24 Hours (time frame: 24 hours post dose). 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 NCT00928668.

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 1 Jul 2014.