Study Of RV-39 In Patients Who Also Have Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00503009
• Other study ID #: HZA109895
• Status: Terminated
• Phase: Phase 4
• First received: July 17, 2007
• Last updated: May 31, 2012
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• fluticasone propionate/salmeterol
comparator
• fluticasone propionate
Comparator
• placebo
Placebo

Locations

Country	Name	City	State
United States	GSK Investigational Site	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Days 1 through 4	No
Secondary	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.	Days 1 through 4	No
Secondary	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.	Days 1 through 4	No
Secondary	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.	Days 1 through 4	No