Asthma Clinical Trial
Official title:
A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children With Asthma
| Verified date | July 2008 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Africa: Medicines Control Council |
| Study type | Interventional |
The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.
| Status | Completed |
| Enrollment | 1050 |
| Est. completion date | June 2008 |
| Est. primary completion date | August 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years to 11 Years |
| Eligibility |
Main Inclusion Criteria: - History of asthma for at least 6 months - Ability to show optimal use of MDI, including inhalation technique - Lung function and reversibility within specified limits Main Exclusion Criteria: - Concomitant severe diseases - Diseases which are contraindications for the use of inhaled steroids - Two or more inpatient hospitalizations for asthma within the last year - Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study - Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6 weeks) - Beginning of or change in immunotherapy within the last 6 months prior to inclusion - Inability to follow the procedures of the study |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Altana Pharma/Nycomed | Plovdiv | |
| Bulgaria | Altana Pharma/Nycomed | Plovdiv | |
| Bulgaria | Altana Pharma/Nycomed | Rousse | |
| Bulgaria | Altana Pharma/Nycomed | Sofia | |
| Bulgaria | Altana Pharma/Nycomed | Vama | |
| Germany | Altana Pharma/Nycomed | Dresden | |
| Germany | Altana Pharma/Nycomed | Freising | |
| Germany | Altana Pharma/Nycomed | Fulda | |
| Germany | Altana Pharma/Nycomed | Homburg | |
| Germany | Altana Pharma/Nycomed | Kassel | |
| Germany | Altana Pharma/Nycomed | Leipzig | |
| Germany | Altana Pharma/Nycomed | Mannheim | |
| Germany | Altana Pharma/Nycomed | Marburg | |
| Germany | Altana Pharma/Nycomed | München | |
| Germany | Altana Pharma/Nycomed | Rosenheim | |
| Germany | Altana Pharma/Nycomed | Schwäbisch Hall | |
| Germany | Altana Pharma/Nycomed | Welzheim | |
| Germany | Altana Pharma/Nycomed | Wesel | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Debrecen | |
| Hungary | Altana Pharma/Nycomed | Jaszbereny | |
| Hungary | Altana Pharma/Nycomed | Kiskunhalas | |
| Hungary | Altana Pharma/Nycomed | Miskolc | |
| Hungary | Altana Pharma/Nycomed | Mosdós | |
| Hungary | Altana Pharma/Nycomed | Mosonmagyaróvár | |
| Hungary | Altana Pharma/Nycomed | Pecs | |
| Hungary | Altana Pharma/Nycomed | Szeged | |
| Poland | Altana Pharma/Nycomed | Inowroclaw | |
| Poland | Altana Pharma/Nycomed | Lodz | |
| Poland | Altana Pharma/Nycomed | Lodz | |
| Poland | Altana Pharma/Nycomed | Lublin | |
| Poland | Altana Pharma/Nycomed | Poznan | |
| Poland | Altana Pharma/Nycomed | Torun | |
| Poland | Altana Pharma/Nycomed | Warszawa | |
| Poland | Altana Pharma/Nycomed | Warszawa | |
| Poland | Altana Pharma/Nycomed | Zawadzkie | |
| Romania | Altana Pharma/Nycomed | Brasov | |
| Romania | Altana Pharma/Nycomed | Bucharest | |
| Romania | Altana Pharma/Nycomed | Bucharest | |
| Romania | Altana Pharma/Nycomed | Bucharest | |
| Romania | Altana Pharma/Nycomed | Bucharest | |
| Romania | Altana Pharma/Nycomed | Bucharest | |
| Romania | Altana Pharma/Nycomed | Bucharest | |
| Romania | Altana Pharma/Nycomed | Cluj-Napoca | |
| Romania | Altana Pharma/Nycomed | Cluj-Napoca | |
| Romania | Altana Pharma/Nycomed | Craiova | |
| Romania | Altana Pharma/Nycomed | Galati | |
| Romania | Altana Pharma/Nycomed | Iasi | |
| Romania | Altana Pharma/Nycomed | Sibiu | |
| Russian Federation | Altana Pharma/Nycomed | Chelyabinsk | |
| Russian Federation | Altana Pharma/Nycomed | Ivanovo | |
| Russian Federation | Altana Pharma/Nycomed | Kislovodsk | |
| Russian Federation | Altana Pharma/Nycomed | Moscow | |
| Russian Federation | Altana Pharma/Nycomed | Moscow | |
| Russian Federation | Altana Pharma/Nycomed | Moscow | |
| Russian Federation | Altana Pharma/Nycomed | Moscow | |
| Russian Federation | Altana Pharma/Nycomed | Moscow | |
| Russian Federation | Altana Pharma/Nycomed | Moscow | |
| Russian Federation | Altana Pharma/Nycomed | Moscow | |
| Russian Federation | Altana Pharma/Nycomed | Moscow | |
| Russian Federation | Altana Pharma/Nycomed | Moscow | |
| Russian Federation | Altana Pharma/Nycomed | Moscow | |
| Russian Federation | Altana Pharma/Nycomed | Murmansk | |
| Russian Federation | Altana Pharma/Nycomed | Novosibirsk | |
| Russian Federation | Altana Pharma/Nycomed | Rostov | |
| Russian Federation | Altana Pharma/Nycomed | Samara | |
| Russian Federation | Altana Pharma/Nycomed | Smolensk | |
| Russian Federation | Altana Pharma/Nycomed | St. Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St. Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St. Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St. Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St. Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St.Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St.Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St.Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St.Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St.Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St.Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | St.Petersburg | |
| Russian Federation | Altana Pharma/Nycomed | Tomsk | |
| Russian Federation | Altana Pharma/Nycomed | Vladimir | |
| Russian Federation | Altana Pharma/Nycomed | Voronezh | |
| South Africa | Altana Pharma/Nycomed | Bellville - Cape Town - | |
| South Africa | Altana Pharma/Nycomed | Bloemfontein | |
| South Africa | Altana Pharma/Nycomed | Cape Town | |
| South Africa | Altana Pharma/Nycomed | Centurion | |
| South Africa | Altana Pharma/Nycomed | Durban | |
| South Africa | Altana Pharma/Nycomed | Durban, Amanzimtoti | |
| South Africa | Altana Pharma/Nycomed | Gezina, Pretoria | |
| 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 | Panorama / RSA-Cape Town | |
| South Africa | Altana Pharma/Nycomed | Somerset West | |
| 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 | Esplugues de Llobregat | |
| Spain | Altana Pharma/Nycomed | Leganés | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Madrid | |
| Spain | Altana Pharma/Nycomed | Manresa | |
| Spain | Altana Pharma/Nycomed | Sabadell (Barcelona) | |
| Spain | Altana Pharma/Nycomed | Tarrasa | |
| Ukraine | Altana Pharma/Nycomed | Dnipropetrovsk | |
| Ukraine | Altana Pharma/Nycomed | Donetsk | |
| Ukraine | Altana Pharma/Nycomed | Donetsk | |
| Ukraine | Altana Pharma/Nycomed | Kharkiv | |
| Ukraine | Altana Pharma/Nycomed | Kiev | |
| Ukraine | Altana Pharma/Nycomed | Kyiv | |
| Ukraine | Altana Pharma/Nycomed | Kyiv | |
| Ukraine | Altana Pharma/Nycomed | Kyiv | |
| Ukraine | Altana Pharma/Nycomed | Lviv | |
| Ukraine | Altana Pharma/Nycomed | Odesa | |
| Ukraine | Altana Pharma/Nycomed | Poltava | |
| Ukraine | Altana Pharma/Nycomed | Simferopol | |
| Ukraine | Altana Pharma/Nycomed | Vinnytsia | |
| Ukraine | Altana Pharma/Nycomed | Zaporizhzhya |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
Bulgaria, Germany, Hungary, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | lung function. | 12 weeks | No | |
| Secondary | asthma symptoms and lung function. | 12 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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