Trial Outcomes & Findings for Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Medium Dose Inhaled Corticosteroid (ICS). (NCT NCT01396278)
NCT ID: NCT01396278
Last Updated: 2025-02-07
Results Overview
Mean change from randomisation baseline to the end of the 8-week treatment period in trough (morning pre-dose and pre-rescue bronchodilator) Forced expiratory volume in one second (FEV1).
TERMINATED
PHASE2
9 participants
At baseline and week 8
2025-02-07
Participant Flow
This randomized, double-blind, double-dummy, active-controlled, parallel group study was to assess and compare efficacy and safety of an 8-week treatment with BI 54903 administered via Respimat® inhaler and fluticasone propionate hydrofluoroalkane Metered dose inhaler in patients with asthma.
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 |
BI 54903 90.9μg Bid
2 puffs (total 90.9 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
BI 54903 181.8μg Bid
2 puffs (total 181.8 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
|
BI 54903 363.6μg Bid
2 puffs (total 363.6 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
|
Fluticasone Propionate 88μg Bid
2 puffs (total 88 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
Fluticasone Propionate 440μg Bid
2 puffs (total 440 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
1
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
2
|
2
|
Reasons for withdrawal
| Measure |
BI 54903 90.9μg Bid
2 puffs (total 90.9 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
BI 54903 181.8μg Bid
2 puffs (total 181.8 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
|
BI 54903 363.6μg Bid
2 puffs (total 363.6 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
|
Fluticasone Propionate 88μg Bid
2 puffs (total 88 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
Fluticasone Propionate 440μg Bid
2 puffs (total 440 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdraw due to trial termination
|
2
|
1
|
1
|
0
|
2
|
Baseline Characteristics
Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Medium Dose Inhaled Corticosteroid (ICS).
Baseline characteristics by cohort
| Measure |
BI 54903 90.9μg Bid
n=2 Participants
2 puffs (total 90.9 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
BI 54903 181.8μg Bid
n=2 Participants
2 puffs (total 181.8 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
|
BI 54903 363.6μg Bid
n=1 Participants
2 puffs (total 363.6 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
|
Fluticasone Propionate 88μg Bid
n=2 Participants
2 puffs (total 88 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
Fluticasone Propionate 440μg Bid
n=2 Participants
2 puffs (total 440 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
37.0 Years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
42.5 Years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
48.0 Years
STANDARD_DEVIATION 0 • n=5 Participants
|
51.0 Years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
50.5 Years
STANDARD_DEVIATION 14.8 • n=21 Participants
|
45.6 Years
STANDARD_DEVIATION 9.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: At baseline and week 8Population: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.
Mean change from randomisation baseline to the end of the 8-week treatment period in trough (morning pre-dose and pre-rescue bronchodilator) Forced expiratory volume in one second (FEV1).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and week 2, 4, 8.Population: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.
Mean changes from randomization baseline in trough (morning pre-dose and pre-rescue bronchodilator) forced vital capacity (FVC) after 2, 4 and 8-week treatment periods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and week 2 and 4.Population: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.
Mean changes from randomization baseline in trough (morning pre-dose and pre-rescue bronchodilator) FEV1 after 2 and 4-week treatment periods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At week 8.Population: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.
Mean pre-dose (and pre-rescue) peak expiratory flow (PEF) as assessed via Asthma Monitor2+ (AM2+) in the morning and evening of the last week of the 8-week treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At week 8.Population: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.
Mean rescue medication use (daytime and night-time) as assessed via AM2+ in the morning and evening of the last week of the 8-week treatment period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and week 2, 4, 8.Population: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.
The Asthma Control Questionnaire (ACQ) consists of 6 patient self-evaluated questions with each question in 7-point scale. The items are equally weighted and the ACQ score is the mean of 6 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
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and week 2, 4, 8.Population: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.
AQLQ(S)+12 are well established and validated questionnaires to measure control of asthma symptoms and quality of life, which is a patient-reported self-administered outcome questionnaire containing 32 items. Each item is scored on a 7-point scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At week 8.Population: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.
Time to withdrawal due to first asthma exacerbation.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and week 2, 4 and 8.Population: Study was terminated by the decision of sponsor. No valid data for primary and secondary endpoints were collected and no analyses of primary and secondary endpoints were conducted.
Mean change from randomization baseline in through (morning pre-dose and pre-rescue bronchodilator) Forced expiratory flow between 25% and 75% of vital capacity (FEF 25-75) after 2, 4 and 8-week treatment periods.
Outcome measures
Outcome data not reported
Adverse Events
BI 54903 90.9μg Bid
BI 54903 181.8μg Bid
BI 54903 363.6μg Bid
Fluticasone Propionate 88μg Bid
Fluticasone Propionate 440μg Bid
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BI 54903 90.9μg Bid
n=2 participants at risk
2 puffs (total 90.9 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
BI 54903 181.8μg Bid
n=2 participants at risk
2 puffs (total 181.8 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
|
BI 54903 363.6μg Bid
n=1 participants at risk
2 puffs (total 363.6 microgram (μg)) of BI 54903 ethanolic solution for inhalation were inhaled orally via Respimat® inhaler (combined with placebo hydrofluoroalkane (HFA) Metered dose inhaler (MDI), 2 puffs twice daily (bid)) twice daily in the morning and evening for a treatment period of 8 weeks.
|
Fluticasone Propionate 88μg Bid
n=2 participants at risk
2 puffs (total 88 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
Fluticasone Propionate 440μg Bid
n=2 participants at risk
2 puffs (total 440 microgram (μg)) of fluticasone propionate were inhaled orally from hydrofluoroalkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler) twice daily (bid) in the morning and evening for a treatment period of 8 weeks.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/1 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
50.0%
1/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
|
Infections and infestations
Nasopharyngitis
|
50.0%
1/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/1 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/1 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
50.0%
1/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/2 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks
The treated sets consist of all randomized patients where at least one dose of study medication was taken.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
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