AsthmaPhase 2NCT01090024

Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

A Phase 2 study testing BI 671800 in people with Asthma, run by Boehringer Ingelheim at 14 sites in United States.

Completed

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

Trial summary

To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid in symptomatic asthma patients. 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
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 108 participants
Where: 14 sitesUnited States
Study dates: 1 Mar 2010to 18 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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
Three month history of reversible (12% with 200 mL) asthma according to [Global Initiative for Asthma (GINA)] with following spirometry at randomization:forced expiratory volume in 1 second (FEV1) 60%-85%.
Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.
Diagnosis of asthma prior to 40 years.
Asthma Control Questionnaire (ACQ) at least 1.5 at randomization.
Male or female, 18 to 65 years.
Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen.
Able to perform pulmonary function test (PFT).

Who cannot join

Significant diseases other than asthma or allergic rhinitis.
Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
Hospitalizations for asthma or asthma related intubation within 3 months.
Uncontrolled asthma on ICS + another controller.
Respiratory tract infection or exacerbation within 4 weeks.
FEV1 less than 40%, more than 12 puffs of short acting beta agonists (SABA) on more than two consecutive days or asthma exacerbation during the run-in period.

Show all 9Show fewer

Participation in another interventional study.
Pregnant or nursing women.
Women of child bearing potential nor using appropriate methods of birth control as defined by protocol.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

1268.53.01003 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1268.53.01009 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado
1268.53.01011 Boehringer Ingelheim Investigational Site
Denver, Colorado
1268.53.01008 Boehringer Ingelheim Investigational Site
El Paso, Texas
1268.53.01013 Boehringer Ingelheim Investigational Site
Huntington Beach, California
1268.53.01005 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
1268.53.01014 Boehringer Ingelheim Investigational Site
Mission Viejo, California
1268.53.01001 Boehringer Ingelheim Investigational Site
North Dartmouth, Massachusetts
1268.53.01010 Boehringer Ingelheim Investigational Site
Portland, Oregon
1268.53.01007 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
1268.53.01015 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1268.53.01012 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1268.53.01006 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1268.53.01002 Boehringer Ingelheim Investigational Site
Stockton, California

Other trials in United States

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Efficacy and Safety Cross-over Study of 4 Weeks of Oral BI 671800 ED 200 mg Twice Daily or 400 mg Once Daily Administered in the Morning (AM) or Evening (PM), in Symptomatic Asthma Patients on Inhaled Fluticasone Propionate MDI

Conditions: Asthma
Being tested: BI 671800, Placebo
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
BI 671800
PlaceboDrug
Placebo matching BI 671800

Study groups in NCT01090024
Study group	Role	What they receive
BI 671800 AM and PM	Experimental	Patients receiving two capsules twice daily Receives: Drug: BI 671800
BI 671800 AM	Experimental	Patients receiving four capsules in the morning Receives: Drug: BI 671800
BI 671800 PM	Experimental	Patients receiving four capsules in the evening Receives: Drug: BI 671800
Placebo	Placebo comparator	Patients receiving four capsules twice a day Receives: Drug: Placebo

What is being measured

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

Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment
Trough FEV1 percent (%) predicted was defined as the mean of the morning and the evening FEV1 % predicted daily trough value at the end of the dosing interval. For the morning (evening) measurements, when FEV1 % predicted was available at both 25 minutes and 10 minutes prior to morning (evening) test-drug inhalation, morning (evening) trough FEV1 % predicted was the mean of these two morning (evening) pre-inhalation measurements. Trough FEV1 % predicted change from baseline after 4 weeks of treatment was defined as the change from baseline in the mean of the morning and the evening trough FEV1 % predicted.
Measured: At baseline and 4 weeks

Secondary outcomes (1)

Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment
The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions and 1 by clinical staff with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 7 items and ranges between 0 (well controlled) and 6 (extremely poorly controlled). Mean scores of less than or equal to 0.75 indicate well-controlled asthma, scores between 0.76 and less than 1.5 indicate partly controlled asthma, and a score greater than or equal to 1.5 indicates uncontrolled asthma.
Measured: At baseline and 4 weeks

Timeline

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

1 Mar 201018 Feb 2011

First posted19 Mar 2010 (estimated)
Study start1 Mar 2010
Primary completion1 Feb 2011
Study completion18 Feb 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: Crossover
Masking: Double blind
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01090024
Sponsor's protocol ID: 1268.53
Status last verified: May 2022
First submitted: 18 Mar 2010
Last updated: 11 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

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled, Efficacy and Safety Cross-over Study of 4 Weeks of Oral BI 671800 ED 200 mg Twice Daily or 400 mg Once Daily Administered in the Morning (AM) or Evening (PM), in Symptomatic Asthma Patients on Inhaled Fluticasone Propionate MDI
ClinicalTrials.gov ID: NCT01090024
Acronym / sponsor ID: 1268.53
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 1 Mar 2010 (actual)
Primary completion: 1 Feb 2011 (actual)
Study completion: 18 Feb 2011 (actual)
First posted: 19 Mar 2010 (estimated)
Results: Posted 11 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: Crossover
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
BI 671800 AM and PM	Experimental	Drug: BI 671800Patients receiving two capsules twice daily
BI 671800 AM	Experimental	Drug: BI 671800Patients receiving four capsules in the morning
BI 671800 PM	Experimental	Drug: BI 671800Patients receiving four capsules in the evening
Placebo	Placebo comparator	Drug: PlaceboPatients receiving four capsules twice a day

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 International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) (ICH-GCP)
Three month history of reversible (12% with 200 mL) asthma according to [Global Initiative for Asthma (GINA)] with following spirometry at randomization:forced expiratory volume in 1 second (FEV1) 60%-85%.
Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.
Diagnosis of asthma prior to 40 years.
Asthma Control Questionnaire (ACQ) at least 1.5 at randomization.

Key exclusion criteria (9 listed)

Significant diseases other than asthma or allergic rhinitis.
Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).
Hospitalizations for asthma or asthma related intubation within 3 months.
Uncontrolled asthma on ICS + another 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 671800BI 671800	Drug	BI 671800 AM, BI 671800 AM and PM, BI 671800 PM
PlaceboPlacebo matching BI 671800	Drug	Placebo

Primary outcome

Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment
Time frame: At baseline and 4 weeks
Trough FEV1 percent (%) predicted was defined as the mean of the morning and the evening FEV1 % predicted daily trough value at the end of the dosing interval. For the morning (evening) measurements, when FEV1 % predicted was available at both 25 minutes and 10 minutes prior to morning (evening) test-drug inhalation, morning (evening) trough FEV1 % predicted was the mean of these two morning (evening) pre-inhalation measurements. Trough FEV1 % predicted change from baseline after 4 weeks of treatment was defined as the change from baseline in the mean of the morning and the evening trough FEV1 % predicted.

1 secondary outcome

Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment
Time frame: At baseline and 4 weeks

Results and safety

Results posted to the registry on 11 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(A)/BI 671800 400mg AM QD (B)/BI 671800 400mg PM QD (C)	6	6
Placebo(A)/BI 671800 400mg AM QD (B)/BI 671800 200 mg BID (D)	6	5
Placebo(A)/BI 671800 400mg PM QD (C)/BI 671800 400mg AM QD (B)	6	6
Placebo (A)/BI 671800 400mg PM QD (C)/BI 671800 200 mg BID (D)	6	5
Placebo(A)/BI 671800 200 mg BID(D)/BI 671800 400 mg AM QD(B)	6	6
Placebo(A)/BI 671800 200 mg BID(D)/BI 671800 400 mg PM QD(C)	6	6
BI 671800 400 mg AM QD(B)/Placebo(A)/BI 671800 400 mg PM QD(C)	6	6
BI 671800 400 mg AM QD(B)/Placebo(A)/BI 671800 200 mg BID(D)	6	6
BI 671800 400 mg AM QD(B)/BI 671800 400 mg PM QD(C)/Placebo(A)	6	6
BI 671800 400 mg AM QD(B)/BI 671800 200 mg BID(D)/Placebo(A)	6	5
BI 671800 400 mg PM QD(C)/Placebo(A)/BI 671800 400 mg AM QD(B)	6	6
BI 671800 400 mg PM QD(C)/Placebo(A)/BI 671800 200 mg BID(D)	6	5
BI 671800 400 mg PM QD(C)/BI 671800 400 mg AM QD(B)/Placebo(A)	6	6
BI 671800 400 mg PM QD(C)/BI 671800 200 mg BID(D)/Placebo(A)	6	6
BI 671800 200 mg BID(D)/Placebo(A)/BI 671800 400 mg AM QD(B)	6	5
BI 671800 200 mg BID(D)/Placebo(A)/BI 671800 400 mg PM QD(C)	6	6
BI 671800 200 mg BID(D)/BI 671800 400 mg AM QD(B)/Placebo(A)	6	6
BI 671800 200 mg BID(D)/BI 671800 400 mg PM QD(C)/Placebo(A)	6	5

Primary outcome: Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment

Time frame: At baseline and 4 weeks. Mean (Standard Error). Unit: Percentage of predicted trough FEV1

Measure	Placebo (A) n = 100	BI 671800 400mg AM QD (B) n = 68	BI 671800 400mg PM QD (C) n = 64	BI 671800 200mg BID (D) n = 64
Value	0.128 (0.536)	0.409 (0.612)	0.798 (0.626)	0.211 (0.626)

Placebo (A) vs BI 671800 200mg BID (D): Adjusted means difference: 0.083 (95% CI -1.147 to 1.313), p = 0.4473, Mixed effect model
Placebo (A) vs BI 671800 400mg PM QD (C): Adjusted means difference: 0.670 (95% CI -0.563 to 1.903), p = 0.1426, Mixed effect model
Placebo (A) vs BI 671800 400mg AM QD (B): Adjusted means difference: 0.281 (95% CI -0.924 to 1.486), p = 0.3231, Mixed effect model

Population analysed: Full analysis set (FAS): All patients randomized, treated with at least one dose of blinded study drug, with a baseline Forced expiratory volume in one second (FEV1) value and at least one on-treatment trough FEV1 value. The FAS is the basis for the intention-to-treat analysis. Participants with non-missing endpoint measurements were included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first dose of study drug until 4 weeks thereafter, up to 4 weeks + 5 days for (serious) adverse events, up to 4 weeks + 2 weeks of follow-up for all-cause mortality.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (A)	0 of 104 (0%)	4 of 104 (3.8%)	0 of 104
BI 671800 400mg AM QD (B)	0 of 70 (0%)	3 of 70 (4.3%)	0 of 70
BI 671800 400mg PM QD (C)	0 of 68 (0%)	5 of 68 (7.4%)	0 of 68
BI 671800 200mg BID (D)	0 of 67 (0%)	2 of 67 (3%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

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

14 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 BI 671800 in people with Asthma, run by Boehringer Ingelheim at 14 sites in United States.

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 11 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 14 sites in United States. 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 11 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?

Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment (time frame: At baseline and 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01090024.

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 11 May 2022.