Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00328718

Enrollment

526

Registered

2006-05-22

Start date

2005-10-31

Completion date

2007-04-30

Last updated

2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Persistent Asthma, pediatric asthmatic, asthma control

Brief summary

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.

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

Interventions

DRUGmontelukast (5mg QD)

DRUGSalmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 14 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Argentina, Colombia, Costa Rica, Mexico, Peru, Turkey (Türkiye), Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026