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.
- Conditions
- AsthmaMedDRA version: 8.1Level: LLTClassification code 10003553Term: Asthma
- Registration Number
- EUCTR2006-001417-16-LV
- Lead Sponsor
- GlaxoSmithKline Research and Development Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Type of Subject: A subject must be treatable on an outpatient basis.
Age: A subject must be 4-11 years of age at Visit 1.
Gender: Male or pre-menarchal female
Disease: Each subject must have a diagnosis of asthma which has required physician-prescribed pharmacotherapy for at least two months prior to Visit 1
Severity of Disease: At Visit 1, after withholding asthma medications, subjects 6-11 years of age must demonstrate a baseline best morning pre-albuterol (salbutamol) clinic FEV1 greater than or equal to 60% of the Polgar predicted value and subjects 4 and 5 years of age must demonstrate a best morning pre-albuterol (salbutamol) clinic AM PEF greater than or equal to 60% of the Polgar predicted value
Reversibility Component: A subject must have historical documentation of an increase in FEV1 or PEF of greater than or equal to 12% within 30 minutes following administration of albuterol (salbutamol) (MDI or nebulized) or levalbuterol within 24 months prior to Visit 1, or current reversible airways disease as demonstrated at Visit 1 by an increase in FEV1 of than or equal to 12% over the pre-albuterol (salbutamol) inhalation aerosol FEV1 (6-11 years) or PEF (4 and 5 years) within 30 minutes after the inhalation of 2-4 puffs (180-360mcg) or one nebulized treatment of albuterol (salbutamol)
Concurrent Anti-Asthma Therapy: Subjects are eligible to participate in the trial if they have been using an inhaled corticosteroid at a consistent dose, within the range specified in the protocol, for at least one month prior to Visit 1
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Life Threatening Asthma: A subject must not have life-threatening asthma. Life threatening asthma is defined for this protocol as a history of significant asthma episode(s) requiring intubation, associated with hypercapnia, respiratory arrest or hypoxic seizures, or asthma-related syncopal episode(s). A subject must not have been hospitalized two or more times in the last year due to asthma
Asthma Medications: Certain Asthma medications as listed in protocol must not have been used prior to Visit 1 for the required interval indicated in the protocol, and not taken during the study.
Corticosteroid Therapy: The use of any corticosteroid medication other than study medication, intranasal corticosteroids, and low potency (of greater than or equal to 1%) topical hydrocortisone cream or ointment during the study is prohibited
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to evaluate the safety of fluticasone propionate/salmeterol 100/50mcg HFA twice daily compared with fluticasone propionate 100mcg HFA twice daily in subjects 4-11 years of age with persistent asthma;Secondary Objective: ;Primary end point(s): The safety measures for this study include adverse events, 12-lead electrocardiograms (ECGs), laboratory tests (hematology/chemistry), 24-hour urinary cortisol excretion, blood pressure, oropharyngeal examination findings, asthma exacerbations, and percent of subjects withdrawn due to worsening asthma.
- Secondary Outcome Measures
Name Time Method