Asthma Clinical Trial
Official title:
BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
| Verified date | December 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | May 2007 |
| Est. primary completion date | November 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 6 Years |
| Eligibility |
Main Inclusion Criteria: - Written informed consent by the parents or legal guardians of the patient - Outpatients - Good health with the exception of asthma - Documented diagnosis of asthma for more than 6 months - Use of rescue medication only or pretreatment with a controller drug Main Exclusion Criteria: - Concomitant severe diseases - Diseases contraindicated for the use of inhaled steroids - Other relevant lung diseases causing impairment in pulmonary function - Recurrent, episodic wheezing only - History of life-threatening asthma - History of any mechanical ventilation - Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation - Premature birth (< 32 weeks gestation) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Altana Pharma/Nycomed | Campinas - SP | |
| Brazil | Altana Pharma/Nycomed | Curitiba-PR | |
| Brazil | Altana Pharma/Nycomed | Paraná | |
| Brazil | Altana Pharma/Nycomed | Pinheiros Sao Paulo - SP | |
| Brazil | Altana Pharma/Nycomed | Porto Alegre-RS | |
| Brazil | Altana Pharma/Nycomed | Porto Alegre-RS | |
| Brazil | Altana Pharma/Nycomed | Recife-PE | |
| Brazil | Altana Pharma/Nycomed | Rio de Janeiro-RJ | |
| Brazil | Altana Pharma/Nycomed | Rio Grande | |
| Brazil | Altana Pharma/Nycomed | Salvador - Bahia | |
| Brazil | Altana Pharma/Nycomed | Santo André-SP | |
| Brazil | Altana Pharma/Nycomed | Sao Paulo | |
| Brazil | Altana Pharma/Nycomed | Sao Paulo | |
| Brazil | Altana Pharma/Nycomed | Sao Paulo | |
| Brazil | Altana Pharma/Nycomed | Sao Paulo | |
| Brazil | Altana Pharma/Nycomed | Sao Paulo - SP | |
| Brazil | Altana Pharma/Nycomed | Sao Paulo-SP | |
| Brazil | Altana Pharma/Nycomed | São Paulo-SP | |
| Germany | Altana Pharma/Nycomed | Berlin | |
| Germany | Altana Pharma/Nycomed | Dresden | |
| Germany | Altana Pharma/Nycomed | Düsseldorf | |
| Germany | Altana Pharma/Nycomed | Frankfurt | |
| Germany | Altana Pharma/Nycomed | Heidelberg | |
| Germany | Altana Pharma/Nycomed | Köln | |
| Germany | Altana Pharma/Nycomed | Mannheim | |
| Germany | Altana Pharma/Nycomed | München | |
| Germany | Altana Pharma/Nycomed | Rosenheim | |
| Germany | Altana Pharma/Nycomed | Wesel | |
| Germany | Altana Pharma/Nycomed | Wiefelstede | |
| Hungary | Altana Pharma/Nycomed | Baja | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Debrecen | |
| Hungary | Altana Pharma/Nycomed | Jaszbereny | |
| Hungary | Altana Pharma/Nycomed | Kaposvár | |
| Hungary | Altana Pharma/Nycomed | Kiskunhalas | |
| Hungary | Altana Pharma/Nycomed | Miskolc | |
| Hungary | Altana Pharma/Nycomed | Mosdós | |
| Hungary | Altana Pharma/Nycomed | Mosonmagyaróvár | |
| Hungary | Altana Pharma/Nycomed | Nyíregyháza | |
| Hungary | Altana Pharma/Nycomed | Pecs | |
| Hungary | Altana Pharma/Nycomed | Szeged | |
| Hungary | Altana Pharma/Nycomed | Szekszárd | |
| Hungary | Altana Pharma/Nycomed | Törökbalint | |
| India | Altana Pharma/Nycomed | Chandanwadi, Thane | |
| India | Altana Pharma/Nycomed | Chennai | |
| India | Altana Pharma/Nycomed | Coimbatore | |
| India | Altana Pharma/Nycomed | Coimbatore | |
| India | Altana Pharma/Nycomed | Coimbatore, Tamilnadu | |
| India | Altana Pharma/Nycomed | Gulbarga | |
| India | Altana Pharma/Nycomed | Mumbai | |
| India | Altana Pharma/Nycomed | Mumbai | |
| India | Altana Pharma/Nycomed | Mumbai, Dadar (E) | |
| India | Altana Pharma/Nycomed | Nagpur | |
| India | Altana Pharma/Nycomed | Noida | |
| India | Altana Pharma/Nycomed | Pune | |
| India | Altana Pharma/Nycomed | Pune | |
| Netherlands | Altana Pharma/Nycomed | Eindhoven | |
| Netherlands | Altana Pharma/Nycomed | Enschede | |
| Netherlands | Altana Pharma/Nycomed | Hoofddorp | |
| Netherlands | Altana Pharma/Nycomed | Leeuwarden | |
| Netherlands | Altana Pharma/Nycomed | Nijmegen | |
| Netherlands | Altana Pharma/Nycomed | Zwolle | |
| Poland | Altana Pharma/Nycomed | Karpacz | |
| Poland | Altana Pharma/Nycomed | Lublin | |
| Poland | Altana Pharma/Nycomed | Opole | |
| Poland | Altana Pharma/Nycomed | Poznan | |
| Poland | Altana Pharma/Nycomed | Poznan | |
| Poland | Altana Pharma/Nycomed | Zawadzkie | |
| South Africa | Altana Pharma/Nycomed | Bellville - Cape Town - | |
| South Africa | Altana Pharma/Nycomed | Cape Town | |
| South Africa | Altana Pharma/Nycomed | Durban | |
| South Africa | Altana Pharma/Nycomed | Morningside, Sandton | |
| South Africa | Altana Pharma/Nycomed | Mowbray, Cape Town | |
| South Africa | Altana Pharma/Nycomed | New Redruth, Alberton | |
| South Africa | Altana Pharma/Nycomed | Overport, Durban | |
| South Africa | Altana Pharma/Nycomed | Panorama / RSA-Cape Town | |
| South Africa | Altana Pharma/Nycomed | Pietermaritzburg | |
| South Africa | Altana Pharma/Nycomed | Westville | |
| South Africa | Altana Pharma/Nycomed | Wynberg | |
| Spain | Altana Pharma/Nycomed | Barcelona | |
| Spain | Altana Pharma/Nycomed | Barcelona | |
| Spain | Altana Pharma/Nycomed | Barcelona | |
| Spain | Altana Pharma/Nycomed | El Palmar (Murcia) | |
| Spain | Altana Pharma/Nycomed | Elche - Alicante | |
| Spain | Altana Pharma/Nycomed | Leganes (Madrid) | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Sabadell | |
| Spain | Altana Pharma/Nycomed | Sevilla | |
| Spain | Altana Pharma/Nycomed | Valencia | |
| Switzerland | Altana Pharma/Nycomed | Lausanne | |
| Switzerland | Altana Pharma/Nycomed | Trimbach | |
| Switzerland | Altana Pharma/Nycomed | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Brazil, Germany, Hungary, India, Netherlands, Poland, South Africa, Spain, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | time to first moderate or severe asthma exacerbation. | 24 weeks | No | |
| Secondary | rate of patients with moderate or severe asthma exacerbation | 24 weeks | No | |
| Secondary | rate of patients with moderate asthma exacerbation | 24 weeks | No | |
| Secondary | rate of patients with severe asthma exacerbation | 24 weeks | No | |
| Secondary | time to first moderate asthma exacerbation | 24 weeks | No | |
| Secondary | time to first severe asthma exacerbation | 24 weeks | No | |
| Secondary | asthma symptom score from diary | 24 weeks | No | |
| Secondary | use of rescue medication | 24 weeks | No | |
| Secondary | patient perceived asthma control | 24 weeks | No | |
| Secondary | quality of life data (PACQLQ) | 24 weeks | No | |
| Secondary | morning and evening PEF from diary | 24 weeks | No | |
| Secondary | pulmonary function variables measured at the investigational sites | 24 weeks | No | |
| Secondary | adverse events | 24 weeks | Yes | |
| Secondary | physical examination | 24 weeks | Yes | |
| Secondary | vital signs | 24 weeks | Yes | |
| Secondary | laboratory work-up | 24 weeks | Yes | |
| Secondary | serum cortisol | 24 weeks | Yes | |
| Secondary | urine cortisol variables | 24 weeks | Yes | |
| Secondary | body growth determined by stadiometry. | 24 weeks | Yes |
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