Trial Outcomes & Findings for Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroid (ICS) (NCT NCT01397201)
NCT ID: NCT01397201
Last Updated: 2022-06-23
Results Overview
Mean change from randomisation baseline to the end of the 8-week treatment period in trough (pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
At baseline and at week 8.
Results posted on
2022-06-23
Participant Flow
Randomised, double-blind, double-dummy, Placebo, parallel group study to assess and compare efficacy and safety on an 8-week Treatment with BI 54903 administered via Respimat® inhaler and fluticasone propionate Hydrofluoralkane 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 |
Placebo
Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
|
BI 54903 45.5µg Bid
2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
BI 54903 90.9 µg Bid
2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
BI 54903 181.8 µg Bid
2 puffs of 90.9 microgram (µg) (total 181.8 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
Fluticasone Propionate 220µg Bid
2 puffs of 110 µg (total 220 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
7
|
5
|
|
Overall Study
Treated
|
6
|
6
|
5
|
7
|
5
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
6
|
5
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
|
BI 54903 45.5µg Bid
2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
BI 54903 90.9 µg Bid
2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
BI 54903 181.8 µg Bid
2 puffs of 90.9 microgram (µg) (total 181.8 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
Fluticasone Propionate 220µg Bid
2 puffs of 110 µg (total 220 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
|
|---|---|---|---|---|---|
|
Overall Study
Not treated
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Not yet defined
|
3
|
6
|
5
|
5
|
4
|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroid (ICS)
Baseline characteristics by cohort
| Measure |
BI 54903 45.5µg Bid
n=6 Participants
2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
BI 54903 90.9 µg Bid
n=5 Participants
2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
BI 54903 181.8 µg Bid
n=7 Participants
2 puffs of 90.9 microgram (µg) (total 181.8 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
Fluticasone Propionate 220µg Bid
n=5 Participants
2 puffs of 110 µg (total 220 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
|
Placebo
n=6 Participants
Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.7 Years
STANDARD_DEVIATION 16.4 • n=5 Participants
|
48.4 Years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
53.7 Years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
42.6 Years
STANDARD_DEVIATION 18.2 • n=4 Participants
|
47.8 Years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
47.8 Years
STANDARD_DEVIATION 12.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
27 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
|
0 Participants
n=5 Participants
|
1 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
23 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 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 change from randomisation baseline to the end of the 8-week treatment period in trough (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 at 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 changes from randomisation baseline in trough (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 at 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 randomisation baseline in trough (pre-dose and pre-rescue bronchodilator) forced expiratory volume in one second (FEV1) after 2 and 4-week treatment periods.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline and at 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
SECONDARY outcome
Timeframe: 8 weeksPopulation: 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 monitor (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 asthma monitor (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 at 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.
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 at 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.
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
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
BI 54903 45.5µg Bid
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 54903 90.9 µg Bid
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BI 54903 181.8 µg Bid
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Fluticasone Propionate 220µg Bid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Oral inhalation from Hydrofluoralkane (HFA) Metered dose inhaler (MDI) (combined with placebo Respimat® inhaler).
|
BI 54903 45.5µg Bid
n=6 participants at risk
2 puffs of 22.7 microgram (µg) (total 45.5 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
BI 54903 90.9 µg Bid
n=5 participants at risk
2 puffs of 45.5 microgram (µg) (total 90.9 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
BI 54903 181.8 µg Bid
n=7 participants at risk
2 puffs of 90.9 microgram (µg) (total 181.8 µg) of BI 54903 ethanolic solution for inhalation were inhaled orally twice daily (bid), in the morning and evening via Respimat® inhaler (combined with 2 puffs placebo Hydrofluoralkane (HFA) Metered dose inhaler (MDI) bid) for a treatment period of 8 weeks.
|
Fluticasone Propionate 220µg Bid
n=5 participants at risk
2 puffs of 110 µg (total 220 µg) Fluticasone propionate were orally administered twice daily (bid) via Hydrofluoralkane (HFA) Metered dose inhaler (MDI), combined with placebo Respimat® inhaler.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
33.3%
2/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
20.0%
1/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
20.0%
1/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
20.0%
1/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum ulceration
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
16.7%
1/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
16.7%
1/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
28.6%
2/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
20.0%
1/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
14.3%
1/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
20.0%
1/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
14.3%
1/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
16.7%
1/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
16.7%
1/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
16.7%
1/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/6 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
14.3%
1/7 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
0.00%
0/5 • From randomization until 8 weeks at end of trial + 2 weeks of follow-up period, up to 10 weeks.
The treated set consists of all randomized patients where at least one dose of study medication was taken.
|
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