Back to resultsStudy Of RV-39 In Patients Who Also Have Asthma
Primary Purpose
Asthma
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
fluticasone propionate/salmeterol
fluticasone propionate
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Rhinovirus, Asthma
Eligibility Criteria
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.
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4
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
Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4
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
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
eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00503009
Brief Title
Study Of RV-39 In Patients Who Also Have Asthma
Official Title
An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone vs Fluticasone Alone to Experimental Nasal Inoculation With Rhinovirus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
lack of data
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Rhinovirus, Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Title
Arm 3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate/salmeterol
Other Intervention Name(s)
fluticasone propionate
Intervention Description
comparator
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate
Intervention Description
Comparator
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4
Description
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.
Time Frame
Days 1 through 4
Secondary Outcome Measure Information:
Title
Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4
Description
PEF measurements were collected via a study-issued electronic peak flow meter. Due to the small sample size, efficacy measures were not analyzed.
Time Frame
Days 1 through 4
Title
Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4
Description
FEV1 measurements were collected via a study-issued spirometer. Due to the small sample size, efficacy measures were not analyzed.
Time Frame
Days 1 through 4
Title
Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4
Description
eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.
Time Frame
Days 1 through 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HZA109895
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HZA109895
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HZA109895
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HZA109895
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HZA109895
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
HZA109895
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Study Of RV-39 In Patients Who Also Have Asthma
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