Last updated: 11/04/2018 08:18:35
Study Of RV-39 In Patients Who Also Have Asthma
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
Official title: An exploratory study to evaluate the response of salmeterol plus fluticasone vs fluticasone alone to experimental nasal inoculation with rhinovirus
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in the cumulative lower respiratory symptom score averaged over Days 1-4
Timeframe: Days 1 through 4
Secondary outcomes:
Change from baseline in the morning Peak Expiratory Flow (PEF) averaged over Days 1-4
Timeframe: Days 1 through 4
Change from baseline in the morning Forced Expiratory Volume in One Second (FEV1) averaged over Days 1-4
Timeframe: Days 1 through 4
Change from baseline in exhaled nitric oxide (eNO) averaged over Days 1-4
Timeframe: Days 1 through 4
Interventions:
Drug: fluticasone propionate/salmeterol
Drug: fluticasone propionate
Drug: placebo
Enrollment:
16
Observational study model:
Not applicable
Primary completion date:
2008-25-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
October 2007 to July 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 40 years
Accepts healthy volunteers
No
- 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.
- Have a history of life-threatening asthma.
- Been hospitalized for asthma within the 24 months prior to the study.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2008-25-07
Actual study completion date
2008-25-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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