Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
This study has been completed.
Sponsor:
Takeda
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00163410
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 compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 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 200 Mcg/Day vs Fluticasone Propionate 200 Mcg/Day in Children 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 % of predicted
- PEF from spirometry
- diary based morning and evening PEF
- diary based symptom score
- diary based salbutamol MDI use
- diurnal PEF fluctuation
- drop-out rate due to asthma exacerbations
- time until asthma exacerbation
- number of symptom free- and rescue medication free days
- number of days with asthma control
- physical examination
- vital signs
- laboratory work-up
- adverse events.
| Estimated Enrollment: | 500 |
| Study Start Date: | April 2003 |
Eligibility| Ages Eligible for Study: | 4 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Main Inclusion Criteria:
- History of persistent bronchial asthma for at least 6 months
- FEV1 50-90% of predicted
Main Exclusion Criteria:
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
- Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
- History of life-threatening asthma
- Premature birth
- Current smoking
- Smoking history with either equal or more than 10 pack-years
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163410
Locations
| India | |
| Altana Pharma/Nycomed | |
| Ahmedabad, India, 380 018 | |
| Altana Pharma/Nycomed | |
| Bangalore, India, 560 034 | |
| Altana Pharma/Nycomed | |
| Chandigarh, India, 160 012 | |
| Altana Pharma/Nycomed | |
| Coimbatore, India, 641 014 | |
| Altana Pharma/Nycomed | |
| Coimbatore, India, 641 004 | |
| Altana Pharma/Nycomed | |
| Coimbatore, Tamilnadu, India, 641 044 | |
| Altana Pharma/Nycomed | |
| Delhi, India, 110 007 | |
| Altana Pharma/Nycomed | |
| Kolkatta, India, 700091 | |
| Altana Pharma/Nycomed | |
| Mumbai, India, 400 022 | |
| Altana Pharma/Nycomed | |
| Mumbai, India, 400 004 | |
| Altana Pharma/Nycomed | |
| Mumbai, India, 400 012 | |
| Altana Pharma/Nycomed | |
| Mumbai, India, 400 026 | |
| Altana Pharma/Nycomed | |
| Pune, India, 411 030 | |
| Altana Pharma/Nycomed | |
| Pune, India, 411 033 | |
| Altana Pharma/Nycomed | |
| Pune, India, 411 001 | |
| Altana Pharma/Nycomed | |
| Shastri Nagar, Jaipur, India, 302 016 | |
Sponsors and Collaborators
Takeda
Investigators
| Study Chair: | Renate Engelstaetter, PhD | ALTANA Pharma, Konstanz, Germany E-mail: info.clintrials@altanapharma.com |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00163410 History of Changes |
| Other Study ID Numbers: | BY9010/M1-205 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 4, 2012 |
| Health Authority: | India: The Drug Controller General of Health Services |
Keywords provided by Takeda:
|
Asthma Ciclesonide Child Fluticasone propionate Pediatric |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Ciclesonide |
Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 17, 2013