Trial Outcomes & Findings for Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease (NCT NCT01391559)
NCT ID: NCT01391559
Last Updated: 2013-08-07
Results Overview
FEV1
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
2 hours
Results posted on
2013-08-07
Participant Flow
Recruitment dates: July 2011 to October 2012; Location: medical clinic
26 patients screened: 5 excluded because did not meet exclusion criteria; 1 excluded because of exacerbation after visit 1.
Participant milestones
| Measure |
Arformoterol First, Then Salmeterol
Arformoterol (15 mcg/2 mL) solution via nebulizer in the first intervention, Salmeterol (50 mcg) Diskus in the second intervention
|
Salmeterol First, Then Arformoterol
Salmeterol (50 mcg) Diskus in the first intervention, Arformoterol (15 mcg/2 mL) solution via nebulizer in the second intervention
|
|---|---|---|
|
First Intervention
STARTED
|
10
|
10
|
|
First Intervention
COMPLETED
|
10
|
10
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
10
|
10
|
|
Second Intervention
COMPLETED
|
10
|
10
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=20 Participants
Includes groups randomized to receive Arformoterol first and Salmeterol first
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
|
Age Continuous
|
71 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursFEV1
Outcome measures
| Measure |
Arformoterol
n=10 Participants
Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
|
Salmeterol
n=10 Participants
Salmeterol dry powder (50 mcg) via Diskus
|
|---|---|---|
|
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at Two Hours After Inhalation of the Study Medication
|
84 mL
Standard Deviation 72
|
52 mL
Standard Deviation 105
|
Adverse Events
Arformoterol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Salmeterol
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