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
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: fluticasone propionate/salmeterol
Drug: fluticasone propionate
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone Propionate vs Fluticasone Propionate Alone to Experimental Nasal Inoculation With Rhinovirus

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 16
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Drug: fluticasone propionate/salmeterol
comparator
Other Names:
  • fluticasone propionate/salmeterol
  • fluticasone propionate
Active Comparator: Arm 2 Drug: fluticasone propionate
Comparator
Other Name: Fluticasone Propionate
Placebo Comparator: Arm 3 Drug: placebo
Placebo
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503009

Locations
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00503009     History of Changes
Other Study ID Numbers: HZA109895
Study First Received: July 17, 2007
Results First Received: July 6, 2009
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Rhinovirus
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Salmeterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014