Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Ciclesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00305461

BY9010/AR-101

Details and patient eligibility

About

The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary function and time to first exacerbation in patients with moderate persistent asthma. Ciclesonide will be administered once daily in the evening at two dose levels. The study duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).

Enrollment: 101 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Written informed consent
• Good health with the exception of asthma
• Clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit B0
• Pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg BDP / day at stable dosing during the last 4 weeks prior to visit B0, concomitant or not to short-acting beta2-agonists treatment as rescue medication
• FEV1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit B0
• Reversibility ≥ 12% and ≥ 200 mL in B0, B0 or T0, after inhalation of 400 mcg of salbutamol
• Patients compliant to recommended pre-treatment

Main Exclusion Criteria:

• Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
• Chronic obstructive pulmonary disease (COPD)
• Hospitalization within previous four weeks from baseline
• Hospitalization due to asthma within the last twelve months
• Asthma exacerbation within two months previous to baseline
• History of almost fatal asthma at any moment
• Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
• Exacerbation of asthma within 2 months prior to entry into the baseline period
• Use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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101 participants in 2 patient groups

1

Active Comparator group

Description:

Ciclesonide 160µg

Treatment:

Drug: Ciclesonide

2

Active Comparator group

Description:

Ciclesonide 320µg

Treatment:

Drug: Ciclesonide