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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: fluticasone propionate/salmeterol; Drug: fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441441

SFA106484

Details and patient eligibility

About

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.

Enrollment: 351 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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351 participants in 2 patient groups

Fluticasone propionate/salmeterol 100/50 HFA

Experimental group

Description:

Fluticasone propionate/salmeterol 100/50 HFA (2 inhalations of 50/25mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate 100mcg HFA inhaler (2 inhalations) twice daily

Treatment:

Drug: fluticasone propionate/salmeterol

Fluticasone propionate 100mcg HFA

Experimental group

Description:

Fluticasone propionate 100mcg HFA (2 inhalations of 50mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate/salmeterol 100/50 HFA inhaler (2 inhalations ) twice daily

Treatment:

Drug: fluticasone propionate