Study Of RV-39 In Patients Who Also Have Asthma

Phase 4

Terminated

• Conditions: Asthma
• Interventions: Drug: fluticasone propionate/salmeterol; Drug: fluticasone propionate; Drug: placebo

• Registration Number: NCT00503009
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Study Start: 2007-10
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Results First Submitted: 2009-07-06
• Results First Submitted QC: 2009-07-06
• Results First Posted: 2009-08-17
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-12-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Have asthma for at least 3 months prior to the study.
• Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
• Demonstrate airway hyperresponsiveness following inhalation of bronchoconstrictor.
• Have a positive allergic status antibody test.

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Exclusion Criteria

• Have a history of life-threatening asthma.
• Been hospitalized for asthma within the 24 months prior to the study.
• Have certain conditions that would make study participation unsafe.
• The study doctor will evaluate other inclusion and exclusion criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	fluticasone propionate/salmeterol	-
Arm 2	fluticasone propionate	-
Arm 3	placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4	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.
Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4	Days 1 through 4	FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed.
Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4	Days 1 through 4	eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Charlottesville, Virginia, United States