NCT02094274

A Single-dose, Randomised, Crossover, Placebo-controlled Study Assessing Two Fixed-dose Combinations of Inhaled Long-acting Beta-agonist and Corticosteroid

A Single-dose, Randomised, Crossover, Placebo-controlled, Double-dummy, Pharmacodynamic Clinical Trial Assessing Two Fixed Dose Combinations of Long-acting Beta-agonist (LABA) and Inhaled Corticosteroid (ICS)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the the ability of a single dose of LAS40468 administered via Genuair® and a single dose of salmeterol/fluticasone propionate (Seretide®) administered via Accuhaler to produce bronchodilation (opening of the airways) and the safety and tolerability of the treatments

Detailed description

This is a Phase 1, randomised, double-blind, double-dummy, cross-over trial to assess the bronchodilation effect of a single dose of LAS40468 and a single dose of salmeterol/fluticasone propionate (Seretide®) administered to adult patients with stable asthma. The study will consist of a screening visit and treatment periods of approximately 13 hours separated by washout periods of 7 to 14 days from the time of Investigational Medicinal product (IMP) administration.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	LAS40468
DRUG	Salmeterol/fluticasone propionate
DRUG	Placebo

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2014-03-21
• Last updated: 2014-05-22

Locations

2 sites across 2 countries: Germany, United Kingdom