Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: fluticasone propionate/salmeterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00364442

SAS10019

Details and patient eligibility

About

A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented history of mild or intermittent asthma
• Have PEF and FEV1>80% predicted
• Not a smoker
• BMI of 19 - 29

Exclusion criteria

• Have had a life threatening episode of asthma
• Have had a respiratory tract infection in the last four weeks
• Have other respiratory disease
• Have taken certain medications within restricted time periods

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 1 patient group

Arm 1

Experimental group

Description:

investigational drug

Treatment:

Drug: fluticasone propionate/salmeterol