Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

January 19, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) via DISKUS† with Oral montelukast (5mg QD) Chewable Tablets in Children 6-14 years of Age with Persistent Asthma

Study Type

Interventional

Enrollment

526

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal-Buenos Aires, Argentina, C1424BSF
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
        • GSK Investigational Site
      • Santa Fe, Argentina, 3000
        • GSK Investigational Site
  • Colombia
      • Bogota, Colombia, 11001000
        • GSK Investigational Site
      • Cali, Colombia, 76001000
        • GSK Investigational Site
      • Medellin, Colombia, 05001000
        • GSK Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • GSK Investigational Site
  • Mexico
      • Chihuahua, Mexico, 31020
        • GSK Investigational Site
      • Mexico, Mexico, 04530
        • GSK Investigational Site
      • Mexico, Mexico, 6720
        • GSK Investigational Site
      • Mexico D.F., Mexico, 03020
        • GSK Investigational Site
      • Mexico D.F., Mexico, 14080
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • GSK Investigational Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • GSK Investigational Site
  • Peru
      • Lima, Peru, Lima 1
        • GSK Investigational Site
      • Lima, Peru, Lima 27
        • GSK Investigational Site
  • Turkey
      • Adana, Turkey, 1330
        • GSK Investigational Site
      • Ankara, Turkey, 6100
        • GSK Investigational Site
      • Antalya, Turkey, 7070
        • GSK Investigational Site
      • Bursa, Turkey, 16059
        • GSK Investigational Site
      • Istanbul, Turkey, 34303
        • GSK Investigational Site
      • Istanbul, Turkey, 34668
        • GSK Investigational Site
      • Izmir, Turkey, 35100
        • GSK Investigational Site
  • Venezuela
      • Caracas, Venezuela, 1010
        • GSK Investigational Site
      • Caracas, Venezuela, 1060
        • GSK Investigational Site
      • Caracas, Venezuela, 1080
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.

Secondary Outcome Measures

Outcome Measure
Changes from baseline to endpoint of:morning pre-dose FEV1 (Forced expiratory volume) symptom free 24 hour-periods rescue medication-free 24 hour-periods mean evening PEFR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2005

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

May 19, 2006

First Submitted That Met QC Criteria

May 19, 2006

First Posted (ESTIMATE)

May 22, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAM103848

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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