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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: November 4, 2016
Last verified: November 2016
July 17, 2007
November 4, 2016
October 2007
July 2008   (Final data collection date for primary outcome measure)
Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4 [ Time Frame: Days 1 through 4 ]
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.
Lower respiratory symptom score
Complete list of historical versions of study NCT00503009 on ClinicalTrials.gov Archive Site
  • Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4 [ Time Frame: Days 1 through 4 ]
    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 ]
    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 ]
    eNO was measured using a study-issued monitor. Due to the small sample size, efficacy measures were not analyzed.
Morning Peak Expiratory Flow Morning Forced Expiratory Volume in 1 second Exhaled Nitric Oxide
Not Provided
Not Provided
 
Study Of RV-39 In Patients Who Also Have Asthma
An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone vs Fluticasone 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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: fluticasone propionate/salmeterol
    comparator
    Other Name: fluticasone propionate
  • Drug: fluticasone propionate
    Comparator
  • Drug: placebo
    Placebo
  • Active Comparator: Arm 1
    Intervention: Drug: fluticasone propionate/salmeterol
  • Active Comparator: Arm 2
    Intervention: Drug: fluticasone propionate
  • Placebo Comparator: Arm 3
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
July 2008
July 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00503009
HZA109895
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP