Trial Outcomes & Findings for Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids (NCT NCT01090024)
NCT ID: NCT01090024
Last Updated: 2022-05-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
108 participants
Primary outcome timeframe
At baseline and 4 weeks
Results posted on
2022-05-11
Participant Flow
This randomised, double-blind, placebo-controlled, cross-over study was to investigate efficacy and safety of 3×4-week treatment periods of oral BI 671800 Ethylenediamine 200 milligram (mg) twice or 400 mg once daily administered in the morning or evening, in symptomatic asthma patients on inhaled fluticasone propionate Metered Dose Inhaler.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Placebo(A)/BI 671800 400mg AM QD (B)/BI 671800 400mg PM QD (C)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
Placebo(A)/BI 671800 400mg AM QD (B)/BI 671800 200 mg BID (D)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
Placebo(A)/BI 671800 400mg PM QD (C)/BI 671800 400mg AM QD (B)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
Placebo (A)/BI 671800 400mg PM QD (C)/BI 671800 200 mg BID (D)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
Placebo(A)/BI 671800 200 mg BID(D)/BI 671800 400 mg AM QD(B)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
Placebo(A)/BI 671800 200 mg BID(D)/BI 671800 400 mg PM QD(C)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
BI 671800 400 mg AM QD(B)/Placebo(A)/BI 671800 400 mg PM QD(C)
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
BI 671800 400 mg AM QD(B)/Placebo(A)/BI 671800 200 mg BID(D)
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
BI 671800 400 mg AM QD(B)/BI 671800 400 mg PM QD(C)/Placebo(A)
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 400 mg AM QD(B)/BI 671800 200 mg BID(D)/Placebo(A)
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 400 mg PM QD(C)/Placebo(A)/BI 671800 400 mg AM QD(B)
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
BI 671800 400 mg PM QD(C)/Placebo(A)/BI 671800 200 mg BID(D)
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
BI 671800 400 mg PM QD(C)/BI 671800 400 mg AM QD(B)/Placebo(A)
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 400 mg PM QD(C)/BI 671800 200 mg BID(D)/Placebo(A)
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 200 mg BID(D)/Placebo(A)/BI 671800 400 mg AM QD(B)
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
BI 671800 200 mg BID(D)/Placebo(A)/BI 671800 400 mg PM QD(C)
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
BI 671800 200 mg BID(D)/BI 671800 400 mg AM QD(B)/Placebo(A)
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 200 mg BID(D)/BI 671800 400 mg PM QD(C)/Placebo(A)
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
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Period 1
STARTED
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6
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6
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6
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6
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6
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6
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6
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6
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6
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6
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6
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6
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Period 1
COMPLETED
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6
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5
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6
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5
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6
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6
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5
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5
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6
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5
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6
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6
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5
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Period 1
NOT COMPLETED
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0
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1
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0
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1
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0
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0
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0
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0
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0
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1
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0
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1
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0
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0
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1
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1
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Period 2
STARTED
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6
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5
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6
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5
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6
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6
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6
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5
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Period 2
COMPLETED
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5
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4
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Period 2
NOT COMPLETED
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1
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0
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0
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1
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0
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0
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0
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0
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0
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0
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Period 3
STARTED
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5
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5
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6
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4
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Period 3
Treated
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5
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4
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5
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5
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Period 3
COMPLETED
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5
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4
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5
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Period 3
NOT COMPLETED
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0
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0
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0
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0
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0
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1
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0
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0
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1
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0
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0
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0
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0
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0
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0
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1
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0
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0
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Reasons for withdrawal
| Measure |
Placebo(A)/BI 671800 400mg AM QD (B)/BI 671800 400mg PM QD (C)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
Placebo(A)/BI 671800 400mg AM QD (B)/BI 671800 200 mg BID (D)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
Placebo(A)/BI 671800 400mg PM QD (C)/BI 671800 400mg AM QD (B)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
Placebo (A)/BI 671800 400mg PM QD (C)/BI 671800 200 mg BID (D)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
Placebo(A)/BI 671800 200 mg BID(D)/BI 671800 400 mg AM QD(B)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
Placebo(A)/BI 671800 200 mg BID(D)/BI 671800 400 mg PM QD(C)
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
BI 671800 400 mg AM QD(B)/Placebo(A)/BI 671800 400 mg PM QD(C)
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
BI 671800 400 mg AM QD(B)/Placebo(A)/BI 671800 200 mg BID(D)
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
BI 671800 400 mg AM QD(B)/BI 671800 400 mg PM QD(C)/Placebo(A)
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 400 mg AM QD(B)/BI 671800 200 mg BID(D)/Placebo(A)
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 400 mg PM QD(C)/Placebo(A)/BI 671800 400 mg AM QD(B)
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
BI 671800 400 mg PM QD(C)/Placebo(A)/BI 671800 200 mg BID(D)
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
BI 671800 400 mg PM QD(C)/BI 671800 400 mg AM QD(B)/Placebo(A)
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 400 mg PM QD(C)/BI 671800 200 mg BID(D)/Placebo(A)
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 200 mg BID(D)/Placebo(A)/BI 671800 400 mg AM QD(B)
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
BI 671800 200 mg BID(D)/Placebo(A)/BI 671800 400 mg PM QD(C)
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
BI 671800 200 mg BID(D)/BI 671800 400 mg AM QD(B)/Placebo(A)
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 200 mg BID(D)/BI 671800 400 mg PM QD(C)/Placebo(A)
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks, followed by (C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks, followed by (A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1
Met exclusion criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 1
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Lost to Follow-up
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 3
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Treated set: All patients treated with at least one dose of blinded study drug. Participants in treated set with non-missing baseline (Week 0) trough FEV1 percent predicted values were included.
Baseline characteristics by cohort
| Measure |
Overall Population
n=108 Participants
All of the enrolled participants that were randomized to one of the treatment sequences for 3 × 4-week treatment periods and treated with at least one dose of study drug.
|
|---|---|
|
Age, Continuous
|
41.1 Years
STANDARD_DEVIATION 12.40 • n=108 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=108 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=108 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=108 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=108 Participants
|
|
Trough forced expiratory volume in one second (FEV1) percent predicted
|
72.816 Percentage of predicted trough FEV1
STANDARD_DEVIATION 7.5759 • n=107 Participants • Treated set: All patients treated with at least one dose of blinded study drug. Participants in treated set with non-missing baseline (Week 0) trough FEV1 percent predicted values were included.
|
PRIMARY outcome
Timeframe: At baseline and 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo (A)
n=100 Participants
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 400mg AM QD (B)
n=68 Participants
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
BI 671800 400mg PM QD (C)
n=64 Participants
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
BI 671800 200mg BID (D)
n=64 Participants
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline of Trough Forced Expiratory Volume in One Second (FEV1) Percent Predicted After 4 Weeks of Treatment
|
0.128 Percentage of predicted trough FEV1
Standard Error 0.536
|
0.409 Percentage of predicted trough FEV1
Standard Error 0.612
|
0.798 Percentage of predicted trough FEV1
Standard Error 0.626
|
0.211 Percentage of predicted trough FEV1
Standard Error 0.626
|
SECONDARY outcome
Timeframe: At baseline and 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Placebo (A)
n=101 Participants
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 400mg AM QD (B)
n=68 Participants
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
BI 671800 400mg PM QD (C)
n=64 Participants
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
BI 671800 200mg BID (D)
n=64 Participants
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
|---|---|---|---|---|
|
Change From Baseline in Asthma Control Questionnaire (ACQ) Mean Score After Four Weeks of Treatment
|
-0.595 Score on a scale
Standard Error 0.059
|
-0.688 Score on a scale
Standard Error 0.066
|
-0.621 Score on a scale
Standard Error 0.068
|
-0.651 Score on a scale
Standard Error 0.068
|
Adverse Events
Placebo (A)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 671800 400mg AM QD (B)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 671800 400mg PM QD (C)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BI 671800 200mg BID (D)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo (A)
n=104 participants at risk
(A) 4 capsules of 100 milligram (mg) of BI 671800 Ethylenediamine (ED) matching placebo (Total 400 mg) administered orally once daily in the morning or 4 capsules of 100 milligram (mg) of BI 671800 ED matching placebo (Total 400 mg) administered orally once daily in the evening for a treatment period of 4 weeks.
|
BI 671800 400mg AM QD (B)
n=70 participants at risk
(B) 4 capsules of 100 milligram (mg) BI 671800 Ethylenediamine (ED) (Total 400 mg) were administered orally once daily (QD) in the morning (AM) for a treatment period of 4 weeks.
|
BI 671800 400mg PM QD (C)
n=68 participants at risk
(C) 4 capsules of 100 milligram (mg) BI 671800 ED (Total 400 mg) were administered orally once daily (QD) in the evening (PM) for a treatment period of 4 weeks.
|
BI 671800 200mg BID (D)
n=67 participants at risk
(D) 2 capsules of 100 milligram (mg) BI 671800 ED (Total 200 mg) were administered orally twice daily (BID) in the morning and in the evening for a treatment period of 4 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
4/104 • 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.
Treated set: All patients treated with at least one dose of blinded study drug. Total number of participants per treatment is lower than the total started number of participants due to participants having left the sequence before being exposed to the respective treatment.
|
4.3%
3/70 • 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.
Treated set: All patients treated with at least one dose of blinded study drug. Total number of participants per treatment is lower than the total started number of participants due to participants having left the sequence before being exposed to the respective treatment.
|
7.4%
5/68 • 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.
Treated set: All patients treated with at least one dose of blinded study drug. Total number of participants per treatment is lower than the total started number of participants due to participants having left the sequence before being exposed to the respective treatment.
|
3.0%
2/67 • 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.
Treated set: All patients treated with at least one dose of blinded study drug. Total number of participants per treatment is lower than the total started number of participants due to participants having left the sequence before being exposed to the respective treatment.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER