Trial Outcomes & Findings for The Effect of Salmeterol on Eosinophil (EOS) Function (NCT NCT00214019)

Results Overview

Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Eosinophils are measured 24 hours after the subject has an antigen challenge

Results posted on

2017-11-21

Participant Flow

Subjects were recruited at UW Hospital and Clinics, Madison, WI from November 2003 to January 2008.

6 participants completed all four arms of the study. 36 participants were recruited; 17 screen failed prior to randomization, 11 were lost to follow up prior to randomization, and 2 withdrew consent prior to randomization.

Participant milestones

Participant milestones
Measure	All Study Participants All participants completed all 4 arms of the study. 28 days per arm.
Overall Study STARTED	36
Overall Study Placebo/Placebo Arm	6
Overall Study Placebo/Salmeterol Arm	6
Overall Study Fluticasone/Placebo Arm	6
Overall Study Fluticason/Salmeterol Arm	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants All participants completed all 4 arms of the study. 28 days per arm.
Overall Study Lost to Follow-up	11
Overall Study Withdrawal by Subject	2
Overall Study Screen Failed prior to randomization	17

Baseline Characteristics

The Effect of Salmeterol on Eosinophil (EOS) Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4 Way Cross Over n=6 Participants Participants completed all 4 arms: Placebo, Salmeterol diskus 40 mcg twice per day, Placebo then fluticasone, Salmeterol then Fluticasone,
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	25.5 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Eosinophils are measured 24 hours after the subject has an antigen challenge

Population: Participants for analysis included any subject that completed that specific treatment phase, even if they did not complete other treatment phases.

Sputum samples were collected from the participants. Cell counts were made from these samples after treatment with 0.1% dithiothreitol. Percentage of eosinophils were reported. Time frame measurement was 24 hours after the subject had an antigen challenge.

Outcome measures

Outcome measures
Measure	Placebo/Placebo n=6 Participants Participants on Placebo/Placebo arm	Placebo/Salmeterol n=6 Participants Participants on Placebo/Salmeterol arm	Placebo/fFuticasone n=6 Participants Participants on Placebo/Fluticasone arm	Salmeterol/Fluticasone n=6 Participants Participants on Salmeterol/Fluticasone
Sputum Eosinophils (EOS) 24 Hours Post Antigen Challenge	3.5 Eosinophil percentage Standard Deviation 3.4	2.4 Eosinophil percentage Standard Deviation 3.4	0.54 Eosinophil percentage Standard Deviation 0.39	2.4 Eosinophil percentage Standard Deviation 2.6

Adverse Events

4 Way Cross Over

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	4 Way Cross Over n=6 participants at risk Participants completed all 4 treatments: Placebo Salmeterol diskus 50 mcg twice per day Placebo then Fluticasone Salmeterol then Fluticasone
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	16.7% 1/6 • Number of events 1 • 2.5 years Subject interview at visit
Respiratory, thoracic and mediastinal disorders Increased asthma symptoms	16.7% 1/6 • Number of events 1 • 2.5 years Subject interview at visit
Musculoskeletal and connective tissue disorders Back Spasm	16.7% 1/6 • Number of events 1 • 2.5 years Subject interview at visit
Respiratory, thoracic and mediastinal disorders Scratchy throat	16.7% 1/6 • Number of events 1 • 2.5 years Subject interview at visit
Vascular disorders Fainted	16.7% 1/6 • Number of events 1 • 2.5 years Subject interview at visit

Additional Information

Gina Crisafi

UW Madison

Phone: 6082654554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place