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Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets

NCT00328718·26 sites·ClinicalTrials.gov

What this study is about

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Saves the questions and what to expect into your notes, next to the visit they belong to.

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Lead

GlaxoSmithKline

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

Age

6–14

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

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.

You may not be if

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.

The record

StatusCompleted

PhasePhase 3

Taking part526

StartedOct 2005

UpdatedJan 20, 2017

Conditions

Where26

GSK Investigational Site
Santa Fe, Santa Fe Province, Argentina
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Capital Federal-Buenos Aires, Argentina

Clareo Health | Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets