Study Of RV-39 In Patients Who Also Have Asthma

This study has been terminated.

(lack of data)

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00503009

First received: July 17, 2007

Last updated: May 31, 2012

Last verified: February 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 17, 2007

Last Updated Date

May 31, 2012

Start Date ^ICMJE

October 2007

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4 [ Time Frame: Days 1 through 4 ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Lower respiratory symptom score

Change History

Complete list of historical versions of study NCT00503009 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4 [ Time Frame: Days 1 through 4 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.

Original Secondary Outcome Measures ^ICMJE

Morning Peak Expiratory Flow Morning Forced Expiratory Volume in 1 second Exhaled Nitric Oxide

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Of RV-39 In Patients Who Also Have Asthma

Official Title ^ICMJE

An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone Propionate vs Fluticasone Propionate Alone to Experimental Nasal Inoculation With Rhinovirus

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: fluticasone propionate/salmeterol
comparator
Other Names:
- fluticasone propionate/salmeterol
- fluticasone propionate
Drug: fluticasone propionate
Comparator

Other Name: Fluticasone Propionate
Drug: placebo
Placebo

Other Name: Placebo

Study Arm (s)

Active Comparator: Arm 1
Intervention: Drug: fluticasone propionate/salmeterol
Active Comparator: Arm 2
Intervention: Drug: fluticasone propionate
Placebo Comparator: Arm 3
Intervention: Drug: placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2008

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00503009

Other Study ID Numbers ^ICMJE

HZA109895

Has Data Monitoring Committee

Responsible Party

GlaxoSmithKline

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

February 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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