Trial Outcomes & Findings for Sub-Sensitivity to Long-Acting Bronchodilators (LABA) (NCT NCT01117116)
NCT ID: NCT01117116
Last Updated: 2026-07-06
Results Overview
Improvements in PC20 as measured by methacholine challenge between the two treatment groups at the end of the first 4 week period to determine efficacy between low dose Advair and Symbicort.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
A baseline methacholine challenge was compared to the methacholine challenge performed after 4 weeks of treatment for each arm.
Results posted on
2026-07-06
Participant Flow
20 subjects males or females 18-65 years of age with physician diagnosed asthma \>12 months will be enrolled in a cross over design using Advair 250 1 bid or Symbicort 80 2 bid. Baseline percent FEV1 \>50% and ≤80%, positive MC or 12% reversibility in the previous 12 months, currently symptomatic with ACT score \<19 at the end of run in, ICS ≥200 and ≤1000 ug/day, non-smoker or ex-smoker with \<10 pk year who stopped \>1 year ago, and bronchodilator response at Visit 1 or 2.
All subjects will enter a 14 day run-in and will be given Fluticasone propionate 88 mcg BID for 14 days. Subjects will capture their PIKO BID with 3 efforts every morning and 3 efforts every night.
Participant milestones
| Measure |
Fluticasone Propionate and Salmeterol
All participants will be randomized in a 1:1 manner to either Arm fluticasone propionate and salmeterol or budesonide and formoterol. 10 participants will take fluticasone propionate and salmeterol 45/21mcg 2 puffs BID first for the initial 28 day period. Subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. Subjects will return to study site at end of 28 days and will have a 12 hour washout prior to visit. At end of study visit subjects will be switched to Arm budesonide and formoterol in a cross over manner. Subjects will begin period 2 and will take budesonide and formoterol 80/4.5 mcg 2 puffs BID for 42 days. During the initial two weeks no study data will be collected. At day 14 subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. At end of the 42 day period subjects will return to clinic for end of treatment visit.
|
Budesonide and Formoterol
All participants will be randomized in a 1:1 manner to either Arm fluticasone propionate and salmeterol or budesonide and formoterol. 10 participants will take budesonide and formoterol 80/4.5 mcg 2 puffs BID first for the initial 28 day period. Subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. Subjects will return to study site at end of 28 days and will have a 12 hour washout prior to visit. At end of study visit subjects will be switched to Arm fluticasone propionate and salmeterol in a cross over manner. Subjects will begin period 2 and will take fluticasone propionate and salmeterol 45/21 mcg 2 puffs BID for 42 days. During the initial two weeks no study data will be collected. At day 14 subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. At end of the 42 day period subjects will return to clinic for end of treatment visit.
|
|---|---|---|
|
Period 1
STARTED
|
10
|
10
|
|
Period 1
COMPLETED
|
10
|
10
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
10
|
10
|
|
Period 2
COMPLETED
|
10
|
10
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate.
Baseline characteristics by cohort
| Measure |
Fluticasone Propionate and Salmeterol
n=10 Participants
All participants will be randomized in a 1:1 manner to either Arm fluticasone propionate and salmeterol or budesonide and formoterol. 10 participants will take fluticasone propionate and salmeterol 45/21mcg 2 puffs BID first for the initial 28 day period. Subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. Subjects will return to study site at end of 28 days and will have a 12 hour washout prior to visit. At end of study visit subjects will be switched to Arm budesonide and formoterol in a cross over manner. Subjects will begin period 2 and will begin taking budesonide and formoterol 80/4.5 mcg 2 puffs BID for 42 days. During the initial two weeks no study data will be collected. At day 14 subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. At end of the 42 day period subjects will return to clinic for end of treatment visit.
|
Budesonide and Formoterol
n=10 Participants
All participants will be randomized in a 1:1 manner to either Arm fluticasone propionate and salmeterol or budesonide and formoterol. 10 participants will take budesonide and formoterol 80/4.5 mcg 2 puffs BID first for the initial 28 day period. Subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. Subjects will return to study site at end of 28 days and will have a 12 hour washout prior to visit. At end of study visit subjects will be switched to Arm fluticasone propionate and salmeterol in a cross over manner. Subjects will begin period 2 and will begin taking fluticasone propionate and salmeterol 45/21 mcg 2 puffs BID for 42 days. During the initial two weeks no study data will be collected. At day 14 subjects will check their PIKO twice a day one in the morning before taking study medication and once at night before taking study medication. Subjects will complete the ACT weekly. At end of the 42 day period subjects will return to clinic for end of treatment visit.ily
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants • All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate.
|
0 Participants
n=10 Participants • All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate.
|
0 Participants
n=20 Participants • All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate.
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants • All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate.
|
10 Participants
n=10 Participants • All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate.
|
20 Participants
n=20 Participants • All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants • All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate.
|
0 Participants
n=10 Participants • All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate.
|
0 Participants
n=20 Participants • All randomized participants were between the ages of 19 and 64 years of age, despite the protocol allowing for participants age 18-65 years of age to participate.
|
|
Sex: Female, Male
Female
|
6 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: A baseline methacholine challenge was compared to the methacholine challenge performed after 4 weeks of treatment for each arm.Population: It was a crossover
Improvements in PC20 as measured by methacholine challenge between the two treatment groups at the end of the first 4 week period to determine efficacy between low dose Advair and Symbicort.
Outcome measures
| Measure |
Fluticasone Propionate and Salmeterol
n=10 Participants
Least squares means (these are the model-adjusted means) for PC20 for drug A
|
Budesonide and Formoterol
n=10 Participants
Least squares means for PC20 for drug B
|
|---|---|---|
|
Improvement in PC20
Period 1
|
0.55 PC20 mg/ml
Interval 0.39 to 0.78
|
0.41 PC20 mg/ml
Interval 0.3 to 0.55
|
|
Improvement in PC20
Period 2
|
0.64 PC20 mg/ml
Interval 0.4 to 0.89
|
0.47 PC20 mg/ml
Interval 0.3 to 0.6
|
Adverse Events
Fluticasone Propionate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fluticasone Propionate and Salmeterol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Budesonide and Formoterol
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