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Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic Patients

NCT01795664 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-09-19

No results posted yet for this study

Summary

This study will be conducted as a randomized, double blind, double dummy two period crossover study in stable asthma patients. A total of 16 stable asthma patients treated in accordance with the Global Initiative for Asthma (GINA) guidelines, will be included.

Objectives:

* The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
* The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated through monitoring of adverse events (AEs) throughout the study.

Conditions

Interventions

RADIATION

Functional Respiratory Imaging

CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose

DRUG

Salmeterol xinafoate and Fluticasone propionate HFA pMDI

Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg At visit 2 or visit 3 (cross-over design)

DRUG

Seretide Evohaler

Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg At visit 2 or visit 3 (cross-over design)

DRUG

Placebo of Test product

Single dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.

DRUG

Placebo of Reference product

Single dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.

Sponsors & Collaborators

  • FLUIDDA nv

    lead INDUSTRY

Principal Investigators

  • Wilfried De Backer, MD, PhD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01795664 on ClinicalTrials.gov