NCT01092143

BI 671800 ED in Steroid-naive Asthmatic Patients

Completed Phase 2 Results posted Last updated 31 May 2022

What this trial tests

Phase 2 trial testing BI 671800 in Asthma in 389 participants. Completed in 26 March 2011.

Timeline

18 March 2010

Primary endpoint
26 March 2011

26 March 2011

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	389
Start date	18 March 2010
Primary completion	26 March 2011
Estimated completion	26 March 2011
Sites	92 locations across New Zealand, Colombia, Peru, Taiwan, Mexico, Philippines, South Korea, Canada

Drugs / interventions tested

• BI 671800
• Fluticasone propionate placebo — full drug profile →
• Fluticasone propionate (FLUTICASONE PROPIONATE) — full drug profile →
• BI 671800 Placebo — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 65, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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 Primary · 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.

Group	Value	95% CI
Placebo	-2.010	± 1.187
BI 671800 50 mg Bid	1.073	± 1.144
BI 671800 200 mg Bid	1.580	± 1.074
BI 671800 400 mg Bid	1.967	± 1.133
Fluticasone 220 mcg Bid	6.610	± 1.194

Asthma Control Questionnaire (ACQ) Mean Score Change From Baseline After Six Weeks of Treatment Secondary · Measurements at baseline (mean ACQ score obtained at Week 0) and at week 6 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 cate

Group	Value	95% CI
Placebo	-0.616	± 0.081
BI 671800 50 mg Bid	-0.543	± 0.078
BI 671800 200 mg Bid	-0.696	± 0.074
BI 671800 400 mg Bid	-0.677	± 0.078
Fluticasone 220 mcg Bid	-0.949	± 0.082

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events: Day of the first dose till the day of the last dose + 5 days residual effect period, up to 61 days. All-Cause Mortality: Day of the first dose till the day of the last dose + 2 weeks follow up, up to 70 days.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo

Serious: 1/78 (1%)

Deaths: 0/78

BI 671800 50 mg Bid

Serious: 0/77 (0%)

Deaths: 0/77

BI 671800 200 mg Bid

Serious: 0/83 (0%)

Deaths: 0/83

BI 671800 400 mg Bid

Serious: 1/79 (1%)

Deaths: 0/79

Fluticasone 220 mcg Bid

Serious: 0/71 (0%)

Deaths: 0/71

Serious adverse events (7 terms)

Reaction	System	Placebo	BI 671800 50 mg Bid	BI 671800 200 mg Bid	BI 671800 400 mg Bid	Fluticasone 220 mcg Bid
Cardiac failure	Cardiac disorders	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Placebo	BI 671800 50 mg Bid	BI 671800 200 mg Bid	BI 671800 400 mg Bid	Fluticasone 220 mcg Bid
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—

Most-reported serious reactions: Cardiac failure, Vision blurred, Nausea, Pneumonia, Dizziness, Headache, Acute respiratory failure.

Data from ClinicalTrials.gov NCT01092143 adverse events section.

Sponsor's own description

This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Regulation of Eosinophilia in Asthma-New Therapeutic Approaches for Asthma Treatment.
   Cusack RP, Whetstone CE, Xie Y, Ranjbar M, et al · · 2021 · cited 22× · PMID 33917396 · DOI 10.3390/cells10040817