Clinical trial NCT00163397: Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)
Official title: A Comparative Study of Inhaled Ciclesonide 160 mcg/Day vs Budesonide 400 mcg/Day in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Ciclesonide
Budesonide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and budesonide will be inhaled once daily at one dose level each. The study duration consists of a baseline period (1 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria: Main Inclusion Criteria:

* During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
* FEV1 80 - 105% of predicted
* Healthy with the exception of asthma
* Written informed consent has been obtained
* Outpatients
* Patients who have a history of persistent bronchial asthma for at least 6 months

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Concomitant COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
* An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
* Patient is current smoker with 10 or more pack-years
* Patient is ex-smoker with 10 or more pack-years

Primary outcomes:
measure: FEV1 absolute values.
Secondary outcomes:
measure: FEV1 as percent of predicted
measure: FVC
measure: PEF absolute values
measure: morning and evening PEF from diary
measure: diurnal PEF fluctuation
measure: asthma symptom score from diary
measure: use of rescue medication from diary
measure: number of symptom free- and rescue medication free days
measure: dropout rate due to asthma exacerbations
measure: time until first asthma exacerbation
measure: number of days with asthma control
measure: onset of effect
measure: subgroup analysis for ex/current smokers and non-smokers
measure: AQLQ(S)
measure: physical examination
measure: vital signs
measure: laboratory work-up
measure: adverse events.
Other outcomes:
Locations:
city: Kota Bharu / Kelantan
country: Malaysia
facility: Altana Pharma/Nycomed
city: Kuala Lumpur
country: Malaysia
facility: Altana Pharma/Nycomed
city: Kuala Lumpur
country: Malaysia
facility: Altana Pharma/Nycomed
city: Kuala Lumpur
country: Malaysia
facility: Altana Pharma/Nycomed
city: Taipei City 114
country: Taiwan
facility: Altana Pharma/Nycomed
city: Taipei
country: Taiwan
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: