Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00364442
First received: August 11, 2006
Last updated: October 9, 2008
Last verified: October 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: fluticasone propionate/salmeterol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Repeat Dose, Randomised, Double Blind, 2-Way Crossover Study to Assess the Safety and Systemic Exposure of SERETIDE/VIANI 50/50 COA Compared to Concurrent Administration of Individual Fluticasone Propionate 50 and Salmeterol 50 DISKUS Inhalers in Subjects Aged 18 - 55 Years With Mild Asthma |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 [ Time Frame: Administration occurred over 14 days and tolerability ]
Secondary Outcome Measures:
- Comparing changes in PD parameters & PK parameters between a low dose of fluticasone propionate/salmeterol compared to concurrent administration of fluticasone propionate and salmeterol [ Time Frame: Administration occurred over 14 days and tolerability ]
| Enrollment: | 12 |
| Study Start Date: | January 2005 |
Intervention Details:
-
Drug: fluticasone propionate/salmeterol
Other Name: fluticasone propionate/salmeterol
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Study Director, GSK |
| ClinicalTrials.gov Identifier: | NCT00364442 History of Changes |
| Other Study ID Numbers: | SAS10019 |
| Study First Received: | August 11, 2006 |
| Last Updated: | October 9, 2008 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by GlaxoSmithKline:
|
asthma |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013