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

A Repeat Dose, Randomised, Double Blind, 2-way Crossover Study to Assess the Safety and Systemic Exposure of an Investigational Formulation Compared to Concurrent Administration of Individual Fluticasone Propionate 50 and Salmeterol 50 DISKUS Inhalers in Subjects Aged 18 - 55 Years With Mild Asthma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00364442

Enrollment

Registered

2006-08-15

Start date

2005-01-28

Completion date

2005-04-13

Last updated

2017-09-29

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

Conditions

Asthma

Keywords

asthma

Brief summary

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.

Interventions

DRUGfluticasone propionate/salmeterol

investigational drug

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame
The primary objective was to look at the safety and tolerability of a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol	Administration occurred over 14 days and tolerability

Secondary

Measure	Time frame
Comparing changes in PD parameters & PK parameters between a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol	Administration occurred over 14 days and tolerability

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026