Study Of RV-39 In Patients Who Also Have Asthma

NCT00503009 | Terminated Phase 4 Results

• 1 other identifier: HZA109895
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Rhinovirus; Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4

  Days 1 through 4

• Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4

  Days 1 through 4

• Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4

  Days 1 through 4

Study Arms (3)

Arm 1

ACTIVE COMPARATOR

Drug: fluticasone propionate/salmeterol

Arm 2

ACTIVE COMPARATOR

Drug: fluticasone propionate

Arm 3

PLACEBO COMPARATOR

Drug: placebo

Interventions

fluticasone propionate/salmeterol DRUG

comparator

Also known as: fluticasone propionate

Arm 1

fluticasone propionate DRUG

Comparator

Arm 2

placebo DRUG

Placebo

Arm 3

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Charlottesville, Virginia, 22908, United States

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination; Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Due to the small sample size, efficacy measures were not analyzed.

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 18, 2007
• Study Start: October 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: December 28, 2016
• Results First Posted: August 17, 2009

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)