Condition category
Respiratory
Date applied
05/01/2010
Date assigned
20/01/2010
Last edited
26/03/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heloisio Rodrigues

ORCID ID

Contact details

Rua Josef Kryss
250
São Paulo
01140-050
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LB0807

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Fluticasone plus Formoterol (Duonare®), Budesonide plus Formoterol (Symbicort Turbuhaler®)

Primary outcome measures

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 trial start date

01/04/2010

Overall trial end date

01/06/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

234 patients

Participant 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

Recruitment start date

01/04/2010

Recruitment end date

01/06/2011

Locations

Countries of recruitment

Brazil

Trial participating centre

Rua Josef Kryss, 250
São Paulo
01140-050
Brazil

Sponsor information

Organisation

Libbs Pharmaceutical Ltd (Brazil)

Sponsor details

Rua Josef Kryss
250
São Paulo
01140-050
Brazil

Sponsor type

Industry

Website

http://www.libbs.com.br/Home.aspx

Funders

Funder type

Industry

Funder name

Libbs Pharmaceutical Ltd (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23849625

Publication citations

  1. Results

    Cukier A, Jacob CM, Rosario Filho NA, Fiterman J, Vianna EO, Hetzel JL, Neis MA, Fiss E, Castro FF, Fernandes AL, Stirbulov R, Pizzichini E, , Fluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma., Respir Med, 2013, 107, 9, 1330-1338, doi: 10.1016/j.rmed.2013.06.018.

Additional files

Editorial Notes