Asthma Clinical Trial
Official title:
Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control
| Verified date | October 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
| Status | Completed |
| Enrollment | 630 |
| Est. completion date | October 2005 |
| Est. primary completion date | October 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years to 75 Years |
| Eligibility |
Main Inclusion Criteria: - Clinical diagnosis of mild persistent asthma - Pre-treatment with SABAs only - FEV1 =80% predicted - Good health with the exception of asthma 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 pulmonary function - Pregnancy - Intention to become pregnant during the course of the study - Breast feeding - Lack of safe contraception - Current smokers =10 pack-years and ex-smokers with =10 pack-years |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Altana Pharma/Nycomed | Adelaide South Australia | |
| Australia | Altana Pharma/Nycomed | Auchenflower | |
| Australia | Altana Pharma/Nycomed | Bracken Ridge | |
| Australia | Altana Pharma/Nycomed | Burwood | |
| Australia | Altana Pharma/Nycomed | Camperdown | |
| Australia | Altana Pharma/Nycomed | Carina Heights | |
| Australia | Altana Pharma/Nycomed | Clayton | |
| Australia | Altana Pharma/Nycomed | Concord | |
| Australia | Altana Pharma/Nycomed | Geelong | |
| Australia | Altana Pharma/Nycomed | Inala | |
| Australia | Altana Pharma/Nycomed | Kippa-ring | |
| Australia | Altana Pharma/Nycomed | Nedlands | |
| Australia | Altana Pharma/Nycomed | Rosebud | |
| Australia | Altana Pharma/Nycomed | South Brisbane | |
| Australia | Altana Pharma/Nycomed | Toorak Gardens | |
| Australia | Altana Pharma/Nycomed | Wayville | |
| Canada | Altana Pharma/Nycomed | Beaconsfield, QC | |
| Canada | Altana Pharma/Nycomed | Coquitlam | |
| Canada | Altana Pharma/Nycomed | Coquitlam, BC | |
| Canada | Altana Pharma/Nycomed | Corner Brook | |
| Canada | Altana Pharma/Nycomed | Cowansville | |
| Canada | Altana Pharma/Nycomed | Kingston, Ontario | |
| Canada | Altana Pharma/Nycomed | Langley BC | |
| Canada | Altana Pharma/Nycomed | Laval | |
| Canada | Altana Pharma/Nycomed | Les Saules, QC | |
| Canada | Altana Pharma/Nycomed | Longueuil, PQ | |
| Canada | Altana Pharma/Nycomed | Montreal | |
| Canada | Altana Pharma/Nycomed | Montreal, PQ | |
| Canada | Altana Pharma/Nycomed | North Bay | |
| Canada | Altana Pharma/Nycomed | North York | |
| Canada | Altana Pharma/Nycomed | Ottawa | |
| Canada | Altana Pharma/Nycomed | Penticton, BC | |
| Canada | Altana Pharma/Nycomed | Quebec City | |
| Canada | Altana Pharma/Nycomed | Saint John | |
| Canada | Altana Pharma/Nycomed | Saint John's | |
| Canada | Altana Pharma/Nycomed | Sainte-Foy, Quebec | |
| Canada | Altana Pharma/Nycomed | Saskatoon, SK | |
| Canada | Altana Pharma/Nycomed | St. John's | |
| Canada | Altana Pharma/Nycomed | Ste-Foy PQ | |
| Canada | Altana Pharma/Nycomed | Toronto | |
| Canada | Altana Pharma/Nycomed | Toronto | |
| Canada | Altana Pharma/Nycomed | Toronto | |
| Canada | Altana Pharma/Nycomed | Toronto ON | |
| Czech Republic | Altana Pharma/Nycomed | Beroun | |
| Czech Republic | Altana Pharma/Nycomed | Ceska Lipa | |
| Czech Republic | Altana Pharma/Nycomed | Cvikov | |
| Czech Republic | Altana Pharma/Nycomed | Havlickuv | |
| Czech Republic | Altana Pharma/Nycomed | Jihlava | |
| Czech Republic | Altana Pharma/Nycomed | Jindrichuv Hradec | |
| Czech Republic | Altana Pharma/Nycomed | Karlovy Vary | |
| Czech Republic | Altana Pharma/Nycomed | Kladno | |
| Czech Republic | Altana Pharma/Nycomed | Kutná Hora | |
| Czech Republic | Altana Pharma/Nycomed | Ostrava-Marián.Hory | |
| Czech Republic | Altana Pharma/Nycomed | Praha 10 | |
| Czech Republic | Altana Pharma/Nycomed | Praha 2 | |
| Czech Republic | Altana Pharma/Nycomed | Praha 4 | |
| Czech Republic | Altana Pharma/Nycomed | Praha 8 | |
| Czech Republic | Altana Pharma/Nycomed | Praha 9 | |
| Czech Republic | Altana Pharma/Nycomed | Pribram VI | |
| Czech Republic | Altana Pharma/Nycomed | Príbram VIII | |
| Czech Republic | Altana Pharma/Nycomed | Rokycany | |
| Czech Republic | Altana Pharma/Nycomed | Strakonice | |
| Czech Republic | Altana Pharma/Nycomed | Trutnov | |
| Czech Republic | Altana Pharma/Nycomed | Usti nad Labem | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Budapest | |
| Hungary | Altana Pharma/Nycomed | Budapest XI | |
| Hungary | Altana Pharma/Nycomed | Budapet | |
| Hungary | Altana Pharma/Nycomed | Kecskemet | |
| Hungary | Altana Pharma/Nycomed | Nyíregyháza | |
| Hungary | Altana Pharma/Nycomed | Szarvas | |
| Hungary | Altana Pharma/Nycomed | Tatabanya | |
| Poland | Altana Pharma/Nycomed | Bydgoszcz | |
| Poland | Altana Pharma/Nycomed | Bydgoszcz | |
| Poland | Altana Pharma/Nycomed | Lodz | |
| Poland | Altana Pharma/Nycomed | Lódz' | |
| Poland | Altana Pharma/Nycomed | Rzeszow | |
| Poland | Altana Pharma/Nycomed | Rzeszow | |
| Poland | Altana Pharma/Nycomed | Warszawa | |
| Poland | Altana Pharma/Nycomed | Wroclaw | |
| Poland | Altana Pharma/Nycomed | Wroclaw | |
| South Africa | Altana Pharma/Nycomed | Arcadia, Pretoria | |
| South Africa | Altana Pharma/Nycomed | Bellville, Cape Town | |
| South Africa | Altana Pharma/Nycomed | Berea, Durban | |
| South Africa | Altana Pharma/Nycomed | Bloemfontein | |
| South Africa | Altana Pharma/Nycomed | Bloemfontein | |
| South Africa | Altana Pharma/Nycomed | Cape Town | |
| South Africa | Altana Pharma/Nycomed | Centurion, Pretoria | |
| South Africa | Altana Pharma/Nycomed | Daveyton | |
| South Africa | Altana Pharma/Nycomed | Durban, Amanzimtoti | |
| South Africa | Altana Pharma/Nycomed | George | |
| South Africa | Altana Pharma/Nycomed | Midrand | |
| South Africa | Altana Pharma/Nycomed | Mowbray, Cape Town | |
| South Africa | Altana Pharma/Nycomed | Paarl | |
| South Africa | Altana Pharma/Nycomed | Panorama / RSA-Cape Town | |
| South Africa | Altana Pharma/Nycomed | Pretoria | |
| Spain | Altana Pharma/Nycomed | Alcorcón (Madrid) | |
| Spain | Altana Pharma/Nycomed | Alicante | |
| Spain | Altana Pharma/Nycomed | Alicante | |
| Spain | Altana Pharma/Nycomed | Barcelona | |
| Spain | Altana Pharma/Nycomed | Campdevanol (Girona) | |
| Spain | Altana Pharma/Nycomed | Elda (Alicante) | |
| Spain | Altana Pharma/Nycomed | Guadalajara | |
| Spain | Altana Pharma/Nycomed | Leganes (Madrid) | |
| Spain | Altana Pharma/Nycomed | Palma de Mallorca | |
| Spain | Altana Pharma/Nycomed | Peralada (Girona) | |
| Spain | Altana Pharma/Nycomed | Petrer (Alicante) | |
| Spain | Altana Pharma/Nycomed | San Vicente del Raspeig (Alicante) | |
| Spain | Altana Pharma/Nycomed | Santiago de Compostela | |
| Spain | Altana Pharma/Nycomed | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Australia, Canada, Czech Republic, Hungary, Poland, South Africa, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | time until the first severe asthma exacerbation occurs | |||
| Primary | number of poorly controlled asthma days. | |||
| Secondary | percentage of days with asthma control | |||
| Secondary | percentage of days with asthma symptoms | |||
| Secondary | percentage of nocturnal awakenings due to asthma | |||
| Secondary | asthma symptom score | |||
| Secondary | number of inhalations of rescue medication | |||
| Secondary | proportion of patients with severe asthma exacerbations | |||
| Secondary | differences in morning PEF from diary | |||
| Secondary | differences in FEV1 and FVC from spirometry | |||
| Secondary | blood eosinophils | |||
| Secondary | AQLQ(S) | |||
| Secondary | health economic data | |||
| Secondary | vital signs | |||
| Secondary | laboratory work-up | |||
| Secondary | adverse events. |
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