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.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60408425

Enrollment

234

Registered

2010-01-20

Start date

2010-04-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Respiratory Asthma

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 reco

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026