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Sponsored by: |
ALTANA Pharma |
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Information provided by: | ALTANA Pharma |
ClinicalTrials.gov Identifier: | NCT00305461 |
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).
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: Ciclesonide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment |
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. |
Enrollment: | 101 |
Study Start Date: | February 2006 |
Study Completion Date: | February 2008 |
Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Ciclesonide 160µg
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Drug: Ciclesonide
Effect of Ciclesonide on Quality of Life
|
2: Active Comparator
Ciclesonide 320µg
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Drug: Ciclesonide
Effect of Ciclesonide on Quality of Life
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Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Argentina | |
Altana Pharma/Nycomed | |
Buenos Aires, Argentina, B1902CSK | |
Altana Pharma/Nycomed | |
Buenos Aires, Argentina, B7540GHQ | |
Altana Pharma/Nycomed | |
Buenos Aires, Argentina, B8000AAT | |
Altana Pharma/Nycomed | |
Cap. Fed., Argentina, C1117ABE | |
Altana Pharma/Nycomed | |
Cap. Fed., Argentina, C1121ABE | |
Altana Pharma/Nycomed | |
Cap. Fed., Argentina, C1221ADC | |
Altana Pharma/Nycomed | |
Cordoba, Argentina, X5016KEH | |
Altana Pharma/Nycomed | |
Mendoza, Argentina, M5500CCG | |
Altana Pharma/Nycomed | |
Santa Fe, Argentina, S2000DSV | |
Altana Pharma/Nycomed | |
Tucuman, Argentina, T4146DAL | |
Altana Pharma/Nycomed | |
Cordoba, Argentina, X5000BFB | |
Altana Pharma/Nycomed | |
Cap. Fed., Argentina, C1427ARN |
Study Director: | Osvaldo Colatruglio, MD | ALTANA Pharma S.A Argentina |
Responsible Party: | Nycomed ( Nycomed GmbH ) |
Study ID Numbers: | BY9010/AR-101 |
Study First Received: | March 21, 2006 |
Last Updated: | June 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00305461 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Asthma Quality of Life Ciclesonide |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Bronchial Diseases Ciclesonide Lung Diseases |
Hypersensitivity, Immediate Quality of Life Asthma Anti-Allergic Agents Respiratory Hypersensitivity |
Bronchial Diseases Immune System Diseases Ciclesonide Asthma Anti-Allergic Agents Pharmacologic Actions Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Lung Diseases Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity |