Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)
This study has been completed.
Sponsor:
Takeda
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163397
First received: September 12, 2005
Last updated: May 4, 2012
Last verified: July 2008
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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 3 |
| 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:
Further study details as provided by Takeda:
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
Takeda
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: | May 4, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Takeda:
|
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 June 18, 2013