Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137) - Full Text View

Sponsor:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163397

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Comparative Study of Inhaled Ciclesonide 160 Mcg/Day vs Budesonide 400 Mcg/Day in Patients With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide Ciclesonide

U.S. FDA Resources

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

FEV1 absolute values.

Secondary Outcome Measures:

FEV1 as percent of predicted
FVC
PEF absolute values
morning and evening PEF from diary
diurnal PEF fluctuation
asthma symptom score from diary
use of rescue medication from diary
number of symptom free- and rescue medication free days
dropout rate due to asthma exacerbations
time until first asthma exacerbation
number of days with asthma control
onset of effect
subgroup analysis for ex/current smokers and non-smokers
AQLQ(S)
physical examination
vital signs
laboratory work-up
adverse events.

Estimated Enrollment:	120
Study Start Date:	January 2004

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163397

Locations

Malaysia
Altana Pharma/Nycomed
Kota Bharu / Kelantan, Malaysia, 16150
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 50586
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 50603
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 56000
Taiwan
Altana Pharma/Nycomed
Taipei, Taiwan
Altana Pharma/Nycomed
Taipei City 114, Taiwan, 886-114

Sponsors and Collaborators

ALTANA Pharma

Investigators

Study Chair:	Jeyaindran Sinnadurai, MD	Hospital Kuala Lumpur, Kuala Lumpur, Malaysia
Study Chair:	Reury-Perng Perng, MD	Veterans General Hospital, Taipei, Taiwan

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00163397 History of Changes
Other Study ID Numbers:	BY9010/M1-137
Study First Received:	September 12, 2005
Last Updated:	July 16, 2008
Health Authority:	Taiwan: Department of Health

Keywords provided by ALTANA Pharma:

Asthma
Ciclesonide
Budesonide

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Ciclesonide
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on February 12, 2012