Last updated: 11/04/2018 11:07:10

Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

GSK study ID
SAM103848
See study documents
Clinicaltrials.gov ID
NCT00328718
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Randomised, double-blind, double-dummy, parallel-group, comparative study of salmeterol/FP 50/100mcg bd inhalation powder via Diskus with oral Montelukast (5mg QD) chewable tablets in Children 6-14 years
Trial description: This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function, asthma control, Health Outcomes including the child’s quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver’s quality of life as measured by Paediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: montelukast (5mg QD)
  • Drug: Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
    • Enrollment:
    526
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Maspero J, Frances Guerra F, Cuevas F et al. Clin Ther 2008 ; 30(4): 1-13
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    October 2005 to April 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 14 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of asthma for at least 6 months (per American Thoracic Society [ATS] definition).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosis of asthma for at least 6 months (per American Thoracic Society [ATS] definition).
    • Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal.
    • More than or 12% FEV1 reversibility following inhalation of salbutamol.
    • Must also be symptomatic on short-acting beta-agonists.
    • Must not have used inhaled corticosteroids over the previous month or LTRAs (Leukotriene antagonists)over the previous 2 weeks. Exclusion criteria:
    • Hospital admission for asthma within 3 months prior to Visit 1.
    • Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit 1.
    • Oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Guadalajara, Jalisco, Mexico, 44340
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Istanbul, Turkey, 34303
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Mexico D.F., Mexico, 14080
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lima, Lima, Peru, Lima 1
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Mexico, Mexico, 6720
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Istanbul, Turkey, 34668
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 25 Results

    Study documents

    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-30-04

    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

    Additional information
    Not applicable
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