Study Of RV-39 In Patients Who Also Have Asthma
This study has been terminated.
(lack of data)
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00503009
First received: July 17, 2007
Last updated: May 31, 2012
Last verified: February 2011
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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:
|
| 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 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 Salmeterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 13, 2013