Clinical trial NCT00441441: A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma
Official title: A Randomized, Double-blind, Parallel Group Study Evaluating the Safety of Fluticasone Propionate/Salmeterol 100/50mcg HFA (2 Inhalations of 50/25mcg) Twice Daily Compared With Fluticasone Propionate 100mcg HFA (2 Inhalations of 50mcg) Twice Daily in Subjects 4-11 Years of Age With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
fluticasone propionate
children
fluticasone propionate/salmeterol
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-03-01
Enrollment: 351
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.


Eligibility criteria: Inclusion criteria:

* Must have asthma.
* Must be currently taking an inhaled corticosteroid.
* Must be able to attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests that are at least 60% of normal (AM FEV1 or PEF).
* Have a historical or current FEV1 or PEF reversibility of \>=12%.

Exclusion criteria:

* Has ever had life-threatening asthma (for example respiratory arrest, mechanical ventilation).
* Has a current ear or respiratory tract infection.
* Has ever had any other major illnesses (such as cystic fibrosis, heart problems, tuberculosis).

Primary outcomes:
measure: Possible Drug-Related Adverse Events
timeFrame: Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)
measure: Investigator Evaluations of Electrocardiogram (ECG) Results
timeFrame: Baseline and Week 12
measure: Clinically Significant Unfavorable ECGs at Week 12
timeFrame: Baseline, Week 12
measure: ECG Measures - Heart Rate
timeFrame: Baseline and Week 12
measure: ECG Measures - QT Interval
timeFrame: Baseline and Week 12
measure: Cardiovascular Adverse Events Reported During Treatment Period
timeFrame: 12-Week Treatment Period
measure: Cardiovascular Adverse Events Reported During the Post-Treatment Period
timeFrame: 5 Days after Week 12
measure: Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols
timeFrame: Treatment period (weeks 1-12)
measure: Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion
timeFrame: Baseline and week 12
measure: Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12
timeFrame: Baseline and Week 12
measure: Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion
timeFrame: Baseline and Week 12
measure: Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use
timeFrame: Baseline and Week 12
measure: Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12
timeFrame: Baseline and Week 12
measure: Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years
timeFrame: Baseline and week 12
measure: AM Peak Expiratory Flow
timeFrame: Baseline and 12-Week Treatment Period
measure: Asthma Symptom Scores
timeFrame: Baseline and 12-Week Treatment Period
measure: Percentage of Symptom Free Days
timeFrame: Baseline and 12-Week Treatment Period
measure: Albuterol Use
timeFrame: Baseline and 12-Week Treatment Period
measure: Percent of Albuterol-free Days
timeFrame: Baseline and 12-Week Treatment Period
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Riverside
country: United States
facility: GSK Investigational Site
state: California
city: Denver
country: United States
facility: GSK Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Ypsilanti
country: United States
facility: GSK Investigational Site
state: Michigan
city: Cortland
country: United States
facility: GSK Investigational Site
state: New York
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: GSK Investigational Site
state: Oregon
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Germantown
country: United States
facility: GSK Investigational Site
state: Tennessee
city: South Burlington
country: United States
facility: GSK Investigational Site
state: Vermont
city: Clayton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Subiaco
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: St. John's
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Brampton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Santiago
country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
city: Viña del Mar
country: Chile
facility: GSK Investigational Site
state: Valparaíso
city: Santiago
country: Chile
facility: GSK Investigational Site
city: San Jose
country: Costa Rica
facility: GSK Investigational Site
city: Bochum
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Guetersloh
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Kleve-Materborn
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Wesel
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Geesthacht
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Ogre
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Utena
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Monterrey N.L
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Chihuahua
country: Mexico
facility: GSK Investigational Site
city: Mexico city
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Rabka
country: Poland
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Novosibirsk
country: Russian Federation
facility: GSK Investigational Site
city: St'Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tomsk
country: Russian Federation
facility: GSK Investigational Site
city: Murcia
country: Spain
facility: GSK Investigational Site
city: San Javier (Murcia)
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Li JS, Qaqundah PY, Weinstein SF, LaForce CF, Ellsworth AV, Ortega HG, Ferro TJ. Fluticasone propionate/salmeterol combination in children with asthma: key cardiac and overall safety results. Clin Res Reg Affairs 2010;27(3):87-95.