Trial Outcomes & Findings for Dose-Response of Salmeterol in Children (NCT NCT01907334)
NCT ID: NCT01907334
Last Updated: 2014-10-07
Results Overview
concentration of methacholine required to increase total airway resistance by 40% (PC40R5)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
1 to 7 days
Results posted on
2014-10-07
Participant Flow
Participant milestones
| Measure |
Advair and Advair Diskuses, Then Advair and Flovent Diskuses
On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.
On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.
|
Advair and Flovent Diskuses, Then Advair and Advair Diskuses
On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.
On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
4
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose-Response of Salmeterol in Children
Baseline characteristics by cohort
| Measure |
All Participants
n=10 Participants
Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg.
|
|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 to 7 daysPopulation: The analysis was performed on all 10 participants.
concentration of methacholine required to increase total airway resistance by 40% (PC40R5)
Outcome measures
| Measure |
Increase in Airway Resistance After Methacholine
n=10 Participants
Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg. On each study day after treatment, methacholine challenge was performed to determine provocational concentration of methacholine which caused a 40% increase in resistance at 5 Hz (PC40R5).
|
|---|---|
|
Total Airway Resistance Increase
Advair and Advair Diskuses
|
47 ln(mg/mL)
Interval 25.18 to 87.78
|
|
Total Airway Resistance Increase
Advair and Flovent Diskuses
|
22.9 ln(mg/mL)
Interval 8.48 to 61.61
|
Adverse Events
Advair and Advair Diskuses, Then Advair and Flovent Diskuses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Advair and Flovent Diskuses, Then Advair and Advair Diskuses
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place