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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2016
• Main ID: NCT00305461
• Date of registration: 21/03/2006
• Prospective Registration: No
• Primary sponsor: AstraZeneca
• Public title: Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)
• Scientific title: A Pilot Study on the Impact of Two Different Doses of Ciclesonide (160 mcg/Day and 320 mcg/Day) Administered in the Evening on Quality of Life in Patients With Moderate Persistent Asthma.
• Date of first enrolment: February 2006
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00305461
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Argentina

Contacts

• Name: AstraZeneca AstraZeneca
• Affiliation: AstraZeneca

Key inclusion & 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



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Ciclesonide

Primary Outcome(s)

differences in FEV1 and FVC from spirometry (T end vs T0). [Time Frame: 8 weeks]

differences in Quality of Life from AQLQ(S) (T end versus T0) [Time Frame: 8 weeks]

time to first exacerbation [Time Frame: 8 weeks]

Secondary Outcome(s)

percentage of asthma symptoms free days [Time Frame: 8 weeks]

percentage of days on which patients perceived asthma control [Time Frame: 8 weeks]

percentage of rescue medication-free days [Time Frame: 8 weeks]

diurnal PEF fluctuation. [Time Frame: 8 weeks]

PEF from spirometry [Time Frame: 8 weeks]

morning and evening PEF from diary [Time Frame: 8 weeks]

percentage of nocturnal awakening-free days [Time Frame: 8 weeks]

use of rescue medication [Time Frame: 8 weeks]

asthma symptom score (daytime score, nighttime score, total score) [Time Frame: 8 weeks]

Secondary ID(s)

BY9010/AR-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors