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A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma

CLINICAL, STRATIFIED, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, WITH A DURATION OF 12 WEEKS TO EVALUATE THE SAFETY AND EFFICACY OF THE COMBINED PRODUCT DISKUS PROPIONATE FLUTICASONA / SALMETEROL, 100/50 MCG ONCE A DAY VERSUS PROPIONATO DE FLUTICASONA DISKUS 100 MCG ONCE A DAY AND PLACEBO IN PEDIATRIC SYNTHETIC PATIENTS (4 TO 11 YEARS OLD) WITH ASTHMA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-027-03
Enrollment
Unknown
Registered
2003-04-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

fluticasone 100 mcg Type of group
Fluticasone 100 mcg will be given once a day in the afternoon. Group name:Placebo Type of group
Placebo will be administered once a day in the afternoon.

Sponsors

GLAXOSMITHKLINE PERU S.A.,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Out-patients Asthma diagnosis Reversibility Short-acting beta-agonist or asthma controlled medication use

Exclusion criteria

Exclusion criteria: Life-threatening asthma Specified asthma medications Chickenpox Drug allergy Respiratory infections Tobacco use Clinical laboratory abnormalities Ophthalmologic conditions Investigation medications Affiliation with investigator site

Design outcomes

Primary

MeasureTime frame
Outcome name:PEF MP daily Measure:Superior efficacy and comparable safety of the combination product fluticasone propionate / salmeterol DISKUS 100/50 mcg once a day compared to fluticasone propionate DISKUS 100 mcg once a day in pediatric patients with asthma aged between 4 and 11 years. Timepoints:12 - 24 hours—

Secondary

MeasureTime frame
Outcome name:Adverse events, percentage of patients discontinued due to deterioration of asthma, results of clinical laboratory tests. Measure:Superior efficacy and comparable safety of fluticasone propionate DISKUS 100 mcg once a day compared with placebo in pediatric patients with asthma aged 4-11 years. Timepoints:week 2—

Countries

Argentina, Chile, Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)