Last updated: 11/04/2018 08:18:35

Study Of RV-39 In Patients Who Also Have Asthma

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GSK study ID
HZA109895
See study documents
Clinicaltrials.gov ID
NCT00503009
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2008-25-07
    Observational study model:
    Not applicable
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Charlottesville, Virginia, United States, 22908
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    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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