Trial Outcomes & Findings for Study Of RV-39 In Patients Who Also Have Asthma (NCT NCT00503009)

Results Overview

The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

16 participants

Primary outcome timeframe

Days 1 through 4

Results posted on

2016-12-28

Participant Flow

Eligible subjects were randomized to one of two sputum induction groups (sputum induction, no sputum induction) and then stratified at a second randomization to one of three treatment groups (Fluticasone Propionate/Salmeterol \[FSC 250/50\] mcg twice a day \[BID\], Fluticasone Propionate \[FP\] 250 mcg BID, or Placebo BID).

Participant milestones

Participant milestones
Measure	FSC 250/50 mcg BID Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily	FP 250 mcg BID Fluticasone Propionate (FP) (250 microgram) twice daily	Placebo Diskus BID Placebo twice daily
Overall Study STARTED	5	5	6
Overall Study COMPLETED	4	3	3
Overall Study NOT COMPLETED	1	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	FSC 250/50 mcg BID Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily	FP 250 mcg BID Fluticasone Propionate (FP) (250 microgram) twice daily	Placebo Diskus BID Placebo twice daily
Overall Study Protocol Violation	1	0	1
Overall Study Withdrawal by Subject	0	1	1
Overall Study Physician Decision	0	1	1

Baseline Characteristics

Study Of RV-39 In Patients Who Also Have Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FSC 250/50 mcg BID n=5 Participants Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily	FP 250 mcg BID n=5 Participants Fluticasone Propionate (FP) (250 microgram) twice daily	Placebo Diskus BID n=6 Participants Placebo twice daily	Total n=16 Participants Total of all reporting groups
Age, Continuous	20.4 years STANDARD_DEVIATION 2.07 • n=5 Participants	20.0 years STANDARD_DEVIATION 1.00 • n=7 Participants	23.0 years STANDARD_DEVIATION 5.83 • n=5 Participants	21.25 years STANDARD_DEVIATION 3.8 • n=4 Participants
Gender Female	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Gender Male	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized White	5 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants	11 participants n=4 Participants
Race/Ethnicity, Customized African American/African Heritage	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native/Native Hawaiian/Pac	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants

PRIMARY outcome

Timeframe: Days 1 through 4

The cumulative lower respiratory symptom score consisted of the summary of individual scores assessing cough, shortness of breath, chest discomfort, and wheezing based on the following scale: 0 (not present); 1=mild, clearly present; 2=moderately severe, uncomfortable; 3=severe (best possible score of 12; worst possible score of 0), interfering with sleep or activity. Due to the small sample size, efficacy measures were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 through 4

PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 through 4

FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days 1 through 4

eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

FSC 250/50 mcg BID

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

FP 250 mcg BID

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo Diskus BID

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FSC 250/50 mcg BID n=5 participants at risk Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily	FP 250 mcg BID n=5 participants at risk Fluticasone Propionate (FP) (250 microgram) twice daily	Placebo Diskus BID n=6 participants at risk Placebo twice daily
Gastrointestinal disorders Heartburn	20.0% 1/5	0.00% 0/5	0.00% 0/6
Gastrointestinal disorders Diarrhea	20.0% 1/5	0.00% 0/5	0.00% 0/6
Infections and infestations Influenza	0.00% 0/5	20.0% 1/5	0.00% 0/6

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER