Trial Outcomes & Findings for Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma (NCT NCT01070888)
NCT ID: NCT01070888
Last Updated: 2021-07-07
Results Overview
Mean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows: (max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-07-07
Participant Flow
October 2010 to October 2012
excluded from failed run-in or not qualify by exercise challenge
Participant milestones
| Measure |
Budesonide First
This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide/formoterol and dummy inhale, 2 inhalations of each, twice daily.
Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks
|
Budesonide/Formoterol First
This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide and dummy inhale, 2 inhalations of each, twice daily.
Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
|
|---|---|---|
|
First Intervention (14 Days)
STARTED
|
2
|
4
|
|
First Intervention (14 Days)
COMPLETED
|
2
|
2
|
|
First Intervention (14 Days)
NOT COMPLETED
|
0
|
2
|
|
Washout (14 Days)
STARTED
|
2
|
2
|
|
Washout (14 Days)
COMPLETED
|
1
|
2
|
|
Washout (14 Days)
NOT COMPLETED
|
1
|
0
|
|
Second Intervention (14 Days)
STARTED
|
1
|
2
|
|
Second Intervention (14 Days)
COMPLETED
|
1
|
2
|
|
Second Intervention (14 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Budesonide First
This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide/formoterol and dummy inhale, 2 inhalations of each, twice daily.
Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks
|
Budesonide/Formoterol First
This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide and dummy inhale, 2 inhalations of each, twice daily.
Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
|
|---|---|---|
|
First Intervention (14 Days)
Adverse Event
|
0
|
1
|
|
First Intervention (14 Days)
Lost to Follow-up
|
0
|
1
|
|
Washout (14 Days)
Physician Decision
|
1
|
0
|
Baseline Characteristics
Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma
Baseline characteristics by cohort
| Measure |
Budesonide First
n=2 Participants
This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
Budesonide first: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
|
Budesonide/Formoterol First
n=4 Participants
This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks,
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 years
n=5 Participants
|
22.5 years
n=7 Participants
|
24.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
FEV1 fall % predicted with exercise
|
15.5 percent fall in FEV1
STANDARD_DEVIATION 0.6 • n=5 Participants
|
61.1 percent fall in FEV1
STANDARD_DEVIATION 13.0 • n=7 Participants
|
45.9 percent fall in FEV1
STANDARD_DEVIATION 25.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksMean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows: (max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))
Outcome measures
| Measure |
Budesonide First
n=1 Participants
This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Then in the subsequent study period take budesonide/formoterol plus dummy inhaler 2 inhalations of each inhaler, twice daily
Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks
|
Budesonide/Formoterol First
n=2 Participants
This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily, then in the subsequent period take budesonide and dummy inhaler 2 puffs twice daily.
Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
|
|---|---|---|
|
Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide
|
-3.1 percentage of fall in FEV1
Standard Deviation 0
|
-19.4 percentage of fall in FEV1
Standard Deviation 30.5
|
Adverse Events
Budesonide/Formoterol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Budesonide
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 |
Budesonide/Formoterol
n=5 participants at risk
This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
Budesonide/Formoterol: Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks
|
Budesonide
n=4 participants at risk
This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.
Budesonide: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/formoterol 180mcg, 2 puffs twice daily for 2 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
asthma exacerbation
|
20.0%
1/5 • Number of events 1 • Throughout entire study, 2 years
|
0.00%
0/4 • Throughout entire study, 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place