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
DOI	https://doi.org/10.1186/ISRCTN60408425
Secondary identifying numbers	LB0807

Submission date: 05/01/2010
Registration date: 20/01/2010
Last edited: 26/03/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Heloisio Rodrigues
Scientific

Rua Josef Kryss, 250
São Paulo
01140-050
Brazil

Study information

Study design	Randomised open label active controlled parallel group safety and efficacy study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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.
Study acronym	DUONARE
Study objectives	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.
Ethics approval(s)	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)
Health condition(s) or problem(s) studied	Asthma
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Fluticasone plus Formoterol (Duonare®), Budesonide plus Formoterol (Symbicort Turbuhaler®)
Primary outcome measure	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 measures	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)
Overall study start date	01/04/2010
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	234 patients
Key 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
Key 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
Date of first enrolment	01/04/2010
Date of final enrolment	01/06/2011

Locations

Countries of recruitment

Brazil

Study participating centre

Rua Josef Kryss, 250

São Paulo
01140-050
Brazil

Sponsor information

Libbs Pharmaceutical Ltd (Brazil)
Industry

Rua Josef Kryss, 250
São Paulo
01140-050
Brazil

Website	http://www.libbs.com.br/Home.aspx
"ROR"	https://ror.org/055kp8612

Funders

Funder type

Industry

Libbs Pharmaceutical Ltd (Brazil)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2013		Yes	No