NCT01090024

Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids

Completed Phase 2 Results posted Last updated 11 May 2022

What this trial tests

Phase 2 trial testing BI 671800 in Asthma in 108 participants. Completed in 18 February 2011.

Timeline

1 March 2010

Primary endpoint
1 February 2011

18 February 2011

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	108
Start date	1 March 2010
Primary completion	1 February 2011
Estimated completion	18 February 2011
Sites	14 locations across United States

Drugs / interventions tested

• BI 671800
• Placebo

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.

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

Group	Value	95% CI
Placebo (A)	0.128	± 0.536
BI 671800 400mg AM QD (B)	0.409	± 0.612
BI 671800 400mg PM QD (C)	0.798	± 0.626
BI 671800 200mg BID (D)	0.211	± 0.626

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

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.

Group	Value	95% CI
Placebo (A)	-0.595	± 0.059
BI 671800 400mg AM QD (B)	-0.688	± 0.066
BI 671800 400mg PM QD (C)	-0.621	± 0.068
BI 671800 200mg BID (D)	-0.651	± 0.068

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo (A)

Serious: 0/104 (0%)

Deaths: 0/104

BI 671800 400mg AM QD (B)

Serious: 0/70 (0%)

Deaths: 0/70

BI 671800 400mg PM QD (C)

Serious: 0/68 (0%)

Deaths: 0/68

BI 671800 200mg BID (D)

Serious: 0/67 (0%)

Deaths: 0/67

Other adverse events (1 terms — click to expand)

Reaction	System	Placebo (A)	BI 671800 400mg AM QD (B)	BI 671800 400mg PM QD (C)	BI 671800 200mg BID (D)
Upper respiratory tract infection	Infections and infestations	—	—	—	—

Data from ClinicalTrials.gov NCT01090024 adverse events section.

Sponsor's own description

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.

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