Clinical trial NCT00305461: Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Quality of Life
Ciclesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-22
Enrollment: 101
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: differences in Quality of Life from AQLQ(S) (T end versus T0)
timeFrame: 8 weeks
measure: time to first exacerbation
timeFrame: 8 weeks
measure: differences in FEV1 and FVC from spirometry (T end vs T0).
timeFrame: 8 weeks
Secondary outcomes:
measure: percentage of days on which patients perceived asthma control
timeFrame: 8 weeks
measure: percentage of asthma symptoms free days
timeFrame: 8 weeks
measure: percentage of rescue medication-free days
timeFrame: 8 weeks
measure: percentage of nocturnal awakening-free days
timeFrame: 8 weeks
measure: asthma symptom score (daytime score, nighttime score, total score)
timeFrame: 8 weeks
measure: use of rescue medication
timeFrame: 8 weeks
measure: PEF from spirometry
timeFrame: 8 weeks
measure: morning and evening PEF from diary
timeFrame: 8 weeks
measure: diurnal PEF fluctuation.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Altana Pharma/Nycomed
city: Buenos Aires
country: Argentina
facility: Altana Pharma/Nycomed
city: Buenos Aires
country: Argentina
facility: Altana Pharma/Nycomed
city: Cap. Fed.
country: Argentina
facility: Altana Pharma/Nycomed
city: Cap. Fed.
country: Argentina
facility: Altana Pharma/Nycomed
city: Cap. Fed.
country: Argentina
facility: Altana Pharma/Nycomed
city: Cap. Fed.
country: Argentina
facility: Altana Pharma/Nycomed
city: Cordoba
country: Argentina
facility: Altana Pharma/Nycomed
city: Cordoba
country: Argentina
facility: Altana Pharma/Nycomed
city: Mendoza
country: Argentina
facility: Altana Pharma/Nycomed
city: Santa Fe
country: Argentina
facility: Altana Pharma/Nycomed
city: Tucuman
country: Argentina
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: