AsthmaPhase 2NCT01103349

BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

A Phase 2 study testing BI 671800 and Montelukast in people with Asthma, run by Boehringer Ingelheim at 53 sites in 9 countries.

Completed

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

Official record

Search all trials

Trial summary

This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function. The study will also provide data on the pharmacokinetics of BI 671800. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: BI 671800 and Montelukast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 243 participants
Where: 53 sitesin 9 countries
Study dates: 20 Apr 2010to 9 Aug 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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent consistent with ICH-GCP
Three month history of reversible (12% and 200 mL in forced expiratory volume in one second - FEV1) asthma (according to GINA) with following spirometry at randomisation: FEV1 60%- 85%.
Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.
Diagnosis of asthma prior to 40 years.
Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.
Male or female 18 to 65 years.
Non-smokers or ex-smokers (less than 10 pack years history) with negative cotinine screen.
Able to perform pulmonary function testing.

Who cannot join

Significant diseases other than asthma or allergic rhinitis.
Hepatic transaminases or total bilirubin greater than 1.5 ULN.
Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.
Uncontrolled asthma on iCS + other controller.
Respiratory tract infection or exacerbation within 4 weeks.
FEV1 less than 40%, more than 12 puffs rescue salbutamol on more than two consecutive days, or asthma exacerbation during run-in period.

Show all 9Show fewer

Participation in another interventional study.
Pregnant or nursing women.
Women of child bearing potential not using appropriate methods of birth control as defined by the study protocol.

Trial locations and contacts

53 sites in 9 countries.

Country

City, postcode or hospital

53 sites in 9 countries

Germany18 sites

1268.16.49018 Boehringer Ingelheim Investigational Site
Aschaffenburg
1268.16.49014 Boehringer Ingelheim Investigational Site
Bamberg
1268.16.49001 Boehringer Ingelheim Investigational Site
Berlin
1268.16.49004 Boehringer Ingelheim Investigational Site
Berlin
1268.16.49010 Boehringer Ingelheim Investigational Site
Berlin
1268.16.49012 Boehringer Ingelheim Investigational Site
Berlin
1268.16.49013 Boehringer Ingelheim Investigational Site
Berlin
1268.16.49016 Boehringer Ingelheim Investigational Site
Berlin
1268.16.49008 Boehringer Ingelheim Investigational Site
Erfurt
1268.16.49005 Boehringer Ingelheim Investigational Site
Frankfurt
1268.16.49015 Boehringer Ingelheim Investigational Site
Frankfurt
1268.16.49011 Boehringer Ingelheim Investigational Site
Hamburg
1268.16.49009 Boehringer Ingelheim Investigational Site
Hanover
1268.16.49017 Boehringer Ingelheim Investigational Site
Hanover
1268.16.49007 Boehringer Ingelheim Investigational Site
Koblenz
1268.16.49006 Boehringer Ingelheim Investigational Site
Lübeck
1268.16.49002 Boehringer Ingelheim Investigational Site
Rüdersdorf
1268.16.49003 Boehringer Ingelheim Investigational Site
Weinheim

Other trials in Germany

South Korea10 sites

1268.16.82008 Boehringer Ingelheim Investigational Site
Anyang
1268.16.82009 Boehringer Ingelheim Investigational Site
Bucheon-si
1268.16.82007 Boehringer Ingelheim Investigational Site
Cheongju-si
1268.16.82006 Boehringer Ingelheim Investigational Site
Daegu
1268.16.82010 Boehringer Ingelheim Investigational Site
Gwangju
1268.16.82001 Boehringer Ingelheim Investigational Site
Seoul
1268.16.82002 Boehringer Ingelheim Investigational Site
Seoul
1268.16.82004 Boehringer Ingelheim Investigational Site
Seoul
1268.16.82005 Boehringer Ingelheim Investigational Site
Seoul
1268.16.82003 Boehringer Ingelheim Investigational Site
Suwon

Other trials in South Korea

United States6 sites

1268.16.01002 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1268.16.01004 Boehringer Ingelheim Investigational Site
Denver, Colorado
1268.16.01005 Boehringer Ingelheim Investigational Site
El Paso, Texas
1268.16.01001 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1268.16.01006 Boehringer Ingelheim Investigational Site
Plymouth, Minnesota
1268.16.01003 Boehringer Ingelheim Investigational Site
Portland, Oregon

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Turkey (Türkiye)5 sites

1268.16.90002 Boehringer Ingelheim Investigational Site
Bursa
1268.16.90003 Boehringer Ingelheim Investigational Site
Istanbul
1268.16.90004 Boehringer Ingelheim Investigational Site
Istanbul
1268.16.90006 Boehringer Ingelheim Investigational Site
Istanbul
1268.16.90001 Boehringer Ingelheim Investigational Site
Mersin

Other trials in Turkey (Türkiye)

Italy4 sites

1268.16.39006 Boehringer Ingelheim Investigational Site
Ferrara
1268.16.39007 Boehringer Ingelheim Investigational Site
Milan
1268.16.39004 Boehringer Ingelheim Investigational Site
Pietra Ligure (SV)
1268.16.39001 Boehringer Ingelheim Investigational Site
Pisa

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United Kingdom4 sites

1268.16.44005 Boehringer Ingelheim Investigational Site
Chertsey
1268.16.44004 Boehringer Ingelheim Investigational Site
London
1268.16.44002 Boehringer Ingelheim Investigational Site
Manchester
1268.16.44003 Boehringer Ingelheim Investigational Site
Southampton

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Sweden3 sites

1268.16.46002 Boehringer Ingelheim Investigational Site
Gothenburg
1268.16.46001 Boehringer Ingelheim Investigational Site
Lund
1268.16.46003 Boehringer Ingelheim Investigational Site
Örebro

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New Zealand2 sites

1268.16.64001 Boehringer Ingelheim Investigational Site
Christchurch NZ
1268.16.64003 Boehringer Ingelheim Investigational Site
Greenlane East Auckland

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Austria1 site

1268.16.43002 Boehringer Ingelheim Investigational Site
Feldbach

Other trials in Austria

About this study

Official title: Randomised, Double Blind, Double Dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 6 Weeks of Oral BI 671800 ED Twice Daily (b.i.d.), Montelukast Once Daily (q.d.) or Placebo in Symptomatic Asthmatic Patients on Low Dose Fluticasone Propionate MDI (Metered Dose Inhaler)

Conditions: Asthma
Being tested: BI 671800, Placebo, Montelukast
Medical subject headings: Asthma

What participants receive

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

BI 671800Drug
Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma
PlaceboDrug
Patients receive placebo capsules and/or encapsulated tablets
MontelukastDrug
Double blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma

Study groups in NCT01103349
Study group	Role	What they receive
BI 671800	Experimental	Patients receive BI 671800 capsules twice daily Receives: Drug: BI 671800
Montelukast	Active comparator	Patients receive Montelukast encapsulated tablets once daily Receives: Drug: Montelukast
Placebo	Placebo comparator	Patients receive placebo capsules and/or encapsulated placebo tablets Receives: Drug: 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) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit.
MMRM in the statistical test comments is Mixed effects model with repeated measures.
Measured: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.

Secondary outcomes (1)

Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment
Asthma Control Questionnaire (ACQ) mean score change from baseline (mean ACQ score obtained at Week 0) after six weeks of treatment.
The Asthma Control Questionnaire (ACQ) is a patient-reported outcome questionnaire containing 7 items. The items are equally weighted and the ACQ score is the mean of the 7 items and therefore between 0 (well controlled) and 6 (extremely poorly controlled) These questions based on recall of the previous 7 days comprise breathlessness, nocturnal waking, symptoms on waking, activity limitation, wheeze, frequency of Short-acting beta-adrenergic (SABA) use, and categorized pre-bronchodilator FEV1% predicted.
Measured: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

Timeline

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

20 Apr 20109 Aug 2011

First posted14 Apr 2010 (estimated)
Study start20 Apr 2010
Primary completion9 Aug 2011
Study completion9 Aug 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.
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: Parallel groups
Masking: Double blind
Enrolment: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01103349
Sponsor's protocol ID: 1268.16
Other IDs: 2009-014551-80, 2009
Status last verified: May 2022
First submitted: 19 Mar 2010
Last updated: 31 May 2022
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 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised, Double Blind, Double Dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 6 Weeks of Oral BI 671800 ED Twice Daily (b.i.d.), Montelukast Once Daily (q.d.) or Placebo in Symptomatic Asthmatic Patients on Low Dose Fluticasone Propionate MDI (Metered Dose Inhaler)
ClinicalTrials.gov ID: NCT01103349
Acronym / sponsor ID: 1268.16
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 243 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 20 Apr 2010 (actual)
Primary completion: 9 Aug 2011 (actual)
Study completion: 9 Aug 2011 (actual)
First posted: 14 Apr 2010 (estimated)
Results: Posted 31 May 2022

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
BI 671800	Experimental	Drug: BI 671800Patients receive BI 671800 capsules twice daily
Montelukast	Active comparator	Drug: MontelukastPatients receive Montelukast encapsulated tablets once daily
Placebo	Placebo comparator	Drug: PlaceboPatients receive placebo capsules and/or encapsulated placebo tablets

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Signed informed consent consistent with ICH-GCP
Three month history of reversible (12% and 200 mL in forced expiratory volume in one second - FEV1) asthma (according to GINA) with following spirometry at randomisation: FEV1 60%- 85%.
Stable inhaled corticosteroids (iCS) dose 3 months prior to screening.
Diagnosis of asthma prior to 40 years.
Asthma Control Questionnaire (ACQ) at least 1.5 at randomisation.

Key exclusion criteria (9 listed)

Significant diseases other than asthma or allergic rhinitis.
Hepatic transaminases or total bilirubin greater than 1.5 ULN.
Hospitalisation for asthma exacerbation or asthma related intubation within 3 months.
Uncontrolled asthma on iCS + other controller.
Respiratory tract infection or exacerbation within 4 weeks.

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
BI 671800Double blind randomised parallel group study to assess efficacy and tolerability of BI 617800 in patients with symptomatic asthma	Drug	BI 671800
PlaceboPatients receive placebo capsules and/or encapsulated tablets	Drug	Placebo
MontelukastDouble blind randomised parallel group study to assess efficacy and tolerability of BI 671800 in patients with symptomatic asthma	Drug	Montelukast

Primary outcome

Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment
Time frame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.
Forced expiratory volume in one second (FEV1) % predicted trough change from baseline (mean observed in the 2 weeks prior to treatment) after 6 weeks of treatment, where trough FEV1 % predicted was defined as the mean of the FEV1 % predicted trough values at 25 minutes and 10 minutes prior to dosing on clinic visit. MMRM in the statistical test comments is Mixed effects model with repeated measures.

1 secondary outcome

Asthma Control Questionnaire (ACQ) Mean Change in Score on a Scale From Baseline After Six Weeks of Treatment
Time frame: Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 of treatment.

Results and safety

Results posted to the registry on 31 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	95	84
BI 671800 400 mg Bid	81	74
Montelukast 10 mg qd	67	63

Primary outcome: Forced Expiratory Volume in One Second (FEV1) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment

Time frame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.. Mean (Standard Deviation). Unit: FEV1 percent predicted

Measure	Placebo n = 81	BI 671800 400 mg Bid n = 74	Montelukast 10 mg qd n = 62
Value	-0.859 (1.029)	3.011 (1.082)	1.510 (1.181)

Placebo vs BI 671800 400 mg Bid: Adjusted mean treatment differences: 3.870 (95% CI 0.931 to 6.809), p = 0.0050, Mixed Models Analysis
Placebo vs Montelukast 10 mg qd: Adjusted mean treatment differences: 2.369 (95% CI -0.713 to 5.452), p = 0.0657, Mixed Models Analysis
BI 671800 400 mg Bid vs Montelukast 10 mg qd: Adjusted mean treatment differences: 1.501 (95% CI -1.652 to 4.653), p = 0.1748, Mixed Models Analysis

Population analysed: Statistical analysis was performed on randomized patients who received at least one dose of treatment and had both baseline and the post-baseline measurement at 6 weeks for the primary efficacy variable.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 64 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 73 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 95 (0%)	18 of 95 (18.9%)	0 of 95
BI 671800 400 mg Bid	1 of 81 (1.2%)	10 of 81 (12.3%)	0 of 81
Montelukast 10 mg qd	0 of 67 (0%)	8 of 67 (11.9%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Asthma

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RecruitingPhase 1
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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

53 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 671800 and Montelukast in people with Asthma, run by Boehringer Ingelheim at 53 sites in 9 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 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 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Germany, South Korea, United States, Turkey (Türkiye), Italy and 4 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 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 31 May 2022). 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) % Predicted Trough Change From Baseline (Mean Observed in the 2 Weeks Prior to Treatment) After Six Weeks of Treatment (time frame: Measurements at baseline (mean observed in the 2 weeks prior to treatment) and at week 6 of treatment.). 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 NCT01103349.

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 31 May 2022.