Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)

AstraZeneca500 enrolled

Overview

The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (2 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

500

Conditions

Asthma

Interventions

Ciclesonide

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Main Inclusion Criteria: * Written informed consent * History of bronchial asthma for at least 6 months * Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination * FEV1 ≥ 80% of predicted Main Exclusion Criteria: * Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs * COPD * Smoking with ≥10 pack-years * Pregnancy * Intention to become pregnant during the course of the study * Breast feeding * Lack of safe contraception

Locations (89)

Altana Pharma/Nycomed

Brussels, Belgium

Altana Pharma/Nycomed

Brussels, Belgium

Altana Pharma/Nycomed

Brussels, Belgium

Altana Pharma/Nycomed

Halen, Belgium

Altana Pharma/Nycomed

Jette, Belgium

Altana Pharma/Nycomed

Maison-Saint-Gérard, Belgium

Outcomes

Primary Outcomes

number of patients with candidiasis of the oropharynx or hoarseness.

Secondary Outcomes

inhaled Corticosteroids Questionnaire (ICQ)

proportion of cases of candidiasis of the oropharynx or

hoarseness at each visit Secondary variables

FEV1, FVC, PEF from spirometry

morning and evening PEF from diaries

diurnal PEF fluctuation

onset of treatment effect

percent days on which patient perceived asthma control

percent of nocturnal awakening-free days

percent of rescue medication free days

percent symptom free days

asthma symptom score

use of rescue medication

time to first asthma exacerbation

number of patients with an asthma exacerbation

AQLQ

number of patients with candidiasis of the oropharynx or hoarseness by severity

physical examination, ECG

vital sings

adverse events

standard laboratory work-up

morning serum cortisol

skin bruising.