Study Of RV-39 In Patients Who Also Have Asthma

Official Title: “An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone Propionate vs Fluticasone Propionate Alone to Experimental Nasal Inoculation With Rhinovirus”

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Arm 3
• Active Comparator: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4
  • Time Frame: Days 1 through 4
    Safety Issue?: No

Secondary Measures

• Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4
  • Time Frame: Days 1 through 4
    Safety Issue?: No
• Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4
  • Time Frame: Days 1 through 4
    Safety Issue?: No
• Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4
  • Time Frame: Days 1 through 4
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: GlaxoSmithKline Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00503009

Study ID Number: HZA109895

ClinicalTrials.gov Identifier: NCT00503009

Health Authority: United States: Food and Drug Administration