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11 February 2012
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| [ Print-friendly version ] |
| The effect of fluticasone and formoterol in combination administered through Dry Powder Inhaler (DPI) versus budesonide and formoterol in combination (Symbicort Turbuhaler) in the maintenance treatment of asthma in adults. |
| ISRCTN | ISRCTN60408425 |
| ClinicalTrials.gov identifier | |
| Public title | The effect of fluticasone and formoterol in combination administered through Dry Powder Inhaler (DPI) versus budesonide and formoterol in combination (Symbicort Turbuhaler) in the maintenance treatment of asthma in adults. |
| Scientific title | Prospective, open, multicentre study on the effect of fluticasone and formoterol in combination administered through Dry Powder Inhaler (DPI) compared to budesonide and formoterol in combination (Symbicort Turbuhaler) in the maintenance treatment of asthma in adults. |
| Acronym | DUONARE |
| Serial number at source | LB0807 |
| Study hypothesis | The fixed combination of a corticosteroid with a long action bronchodilator has been used in the control of moderate to severe asthma. Isolated fluticasone and isolated formoterol are approved for asthma control treatment. The aim of this study is to prove that the combination of fluticasone and formoterol is safe and effective. |
| Lay summary | |
| Ethics approval | 1. Local ethics approval was issued on the 4th of January 2010 by Ethic Committee of São Paulo Federal University/São Paulo Hospital (ref: CEP 1770/09) |
| Study design | Randomised open label active controlled parallel group safety and efficacy study |
| Countries of recruitment | Brazil |
| Disease/condition/study domain | Asthma |
| Participants - inclusion criteria |
1. Male or female from 18 to 65 years old with known history of asthma according to Global Initiative for Asthma (GINA) update 2008 criteria for at least three months.
2. Patients with partially controlled or non-controlled asthma using therapeutic doses of inhaled corticosteroid combined with long-acting bronchodilator (daily doses equal or more than 400 mcg of budesonide or similar drugs) for at least four weeks 3. Forced Expiratory Volume in 1 second (FEV1) > 60 % of predicted normal value 4. Willing and able to keep diary and attend all visits 5. Written informed consent obtained |
| Participants - exclusion criteria |
1. Pregnant or nursing womem
2. Females of childbearing potential withoud an effective method of birth control 3. Use of systemic corticosteroid within 30 days before randomization 4. Three or more treatments with oral corticosteroid or history of asthma hospitalization in the previous six months 5. Use of the following drugs within two weeks before randomization: 5.1. meltixantines 5.2. monoaminoxidases 5.3. beta-blockers 5.4. acetilscisteine 5.5. carbocisteine 5.6. triciclic antidepressive 5.7. sodium channel blockers 5.8. leukotriene 5.9. anticolinergic 5.10. phenotiazidics 5.11. immunotherapy 5.12. levodopa 5.13. ritonavir 5.14. oral ketoconozal 6. Current evidence of history of hypersensitivity to the study drug 7. Evidence of non-adhesion to the treatment during run-in phase 8. A smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes/day for 10 years or 10 packs/day for 1 year, etc) 9. Clinically significant laboratory test results during the screening phase 10. Morning serum level of cortisol < 5 mcg/dL 11. Inability to perform the lung function test 12. Current evidence of other pulmonary disease 13. Patients with asthma exacerbation during the run-in period 14. Evidence of clinically significant oral candidiasis |
| Anticipated start date | 01/04/2010 |
| Anticipated end date | 01/06/2011 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 234 patients |
| Interventions |
Subjects will be randomised to receive either futicasone 250mcg + formoterol 12mcg (Duonare®) or budesonide 400mcg plus formoterol 12 mcg (Symbicort Turbuhaler®) twice daily (BID).
Subjects will record their compliance with the twice daily inhaler dosing, diary questions and peak expiratory rates will also be recorded twice daily Six clinic visits will are foreseen. In all visits, subjects will be submitted to a pulmonary function test. |
| Primary outcome measure(s) | Evaluate the effect of the combined fluticasone and formoterol DPI BID for 12 weeks compared to the combined budesonide and formoterol Turbuhaler BID for 12 week using morning peak expiratory flow rate (PEFR) |
| Secondary outcome measure(s) |
1. FEV1
2. Evening peak expiratory flow rate (PEFR) 3. Clinical endpoints 3.1. frequency of asthma exacerbations & symptoms 3.2. rescue medication and others patient data captured in diary) |
| Sources of funding | Libbs Pharmaceutical Ltd (Brazil) |
| Trial website | |
| Publications | |
| Contact name | Dr Heloisio Rodrigues |
| Address | Rua Josef Kryss, 250 |
| City/town | São Paulo |
| Zip/Postcode | 01140-050 |
| Country | Brazil |
| Sponsor | Libbs Pharmaceutical Ltd (Brazil) |
| Address | Rua Josef Kryss, 250 |
| City/town | São Paulo |
| Zip/Postcode | 01140-050 |
| Country | Brazil |
| Sponsor website: | http://www.libbs.com.br/Home.aspx |
| Date applied | 05/01/2010 |
| Last edited | 22/01/2010 |
| Date ISRCTN assigned | 20/01/2010 |
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