Trial Outcomes & Findings for Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway (NCT NCT01231230)

NCT ID: NCT01231230

Last Updated: 2016-06-30

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: maximum change in Qaw within 240 minutes post drug inhalation
• Results posted on: 2016-06-30

Participant Flow

Subjects were recruited from our Asthma Database. Subjects with asthma who are in our database have previously agreed to serve as potential subjects in future studies. These subjects have signed an informed consent (approved by UM IRB) to be included in this database.

Participant milestones

Measure	All Study Groups inhalation of 250 mcg of fluticasone fluticasone: 220- mcg once
Overall Study STARTED	14
Overall Study Fluticasone	14
Overall Study Salmeterol	14
Overall Study Fluticasone/Salmeterol	14
Overall Study Placebo	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interactive Acute Smooth Muscle Effects of Salmeterol and Fluticasone in the Airway

Baseline characteristics by cohort

Measure	All Study Participants n=14 Participants participant received in random order one of the four treatments ( fluticasone, salmeterol, fluticasone+salmeterol or placebo)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants
Airway blood flow (Qaw)	54.8 µl.min-1.ml-1 STANDARD_DEVIATION 2.6 • n=5 Participants

PRIMARY outcome

Timeframe: maximum change in Qaw within 240 minutes post drug inhalation

Outcome measures

Measure	Fluticasone n=14 Participants inhalation of 250 mcg of fluticasone fluticasone: 220- mcg once	Placebo n=14 Participants inhalation of placebo diskus placebo inhalation: placebo inhalation once	Salmeterol n=14 Participants inhalation of salmeterol 50 mcg once Salmeterol: 50 mcg salmeterol once Salmeterol: 50 mcg once	Fluticasone/Salmeterol n=14 Participants inhalation of fluticasone 250mcg combined with salmeterol 50 mcg fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol
Maximum Change From Baseline in Airway Blood Flow (Qaw)	-11.0 change from baseline ( µl/min/ml) Standard Error 2.9	14.1 change from baseline ( µl/min/ml) Standard Error 1.9	23.9 change from baseline ( µl/min/ml) Standard Error 3.6	25.5 change from baseline ( µl/min/ml) Standard Error 4.7

Adverse Events

Fluticasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Fluticasone/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

Adam Wanner, MD

University of Miami

Phone: (305)243-2568

Email: awanner@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place