Study Of RV-39 In Patients Who Also Have Asthma
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|ClinicalTrials.gov Identifier: NCT00503009|
Recruitment Status : Terminated (lack of data)
First Posted : July 18, 2007
Results First Posted : August 17, 2009
Last Update Posted : December 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: fluticasone propionate/salmeterol Drug: fluticasone propionate Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone vs Fluticasone Alone to Experimental Nasal Inoculation With Rhinovirus|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
|Active Comparator: Arm 1||
Drug: fluticasone propionate/salmeterol
Other Name: fluticasone propionate
|Active Comparator: Arm 2||
Drug: fluticasone propionate
|Placebo Comparator: Arm 3||
- Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4 [ Time Frame: 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.
- Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Days 1 through 4 ]eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503009
|United States, Virginia|
|GSK Investigational Site|
|Charlottesville, Virginia, United States, 22908|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|