To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product

Study Comparing Bronchodilator Efficacy of Two Dry Powder Inhalers, Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler; a Randomised, Double-blind, Double-dummy, Multicentre, Single Dose, Crossover Study in Asthmatic Subjects

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02308098

Acronym

BUFODIL

Enrollment

Registered

2014-12-04

Start date

2014-12-31

Completion date

2015-06-30

Last updated

2015-06-30

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

Conditions

Asthma

Brief summary

The purpose of this study is to confirm equivalent bronchodilator efficacy of the test product compared to the reference product.

Interventions

DRUGPlacebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh

DRUGBudesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh

DRUGBudesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh

DRUGSymbicort Turbuhaler 320/9 ug/inhalation 4 inh

DRUGSymbicort Turbuhaler 320/9 ug/inhalation 1inh

DRUGPlacebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh

DRUGPlacebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh

DRUGPlacebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Main inclusion criteria: * Written informed consent * Asthma diagnosis for at least 6 months * Prebronchodilator FEV1 45-90% of the predicted value * Demonstration of reversible airway obstruction * Stable asthma on the same regular treatment for at least 4 weeks before the study * Non-smoker for at least 6 months before the study Main

Exclusion criteria

* Respiratory infection within 4 weeks before the study * Smoking history of more than 10 pack-years * Other severe chronic respiratory disease than asthma * Concurrent illness that would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study * Corrected QT interval \> 450 ms in males or \> 470 ms in females * Abnormal serum potassium value or other clinically significant laboratory finding * Systolic blood pressure over 180 mmHg and/or diastolic blood pressure over 100 mmHg * Treatment with a long-acting β2-agonist, a xanthine-derivative, a β-blocker or with a corticosteroid (other than inhaled) within 4 weeks before the study * Use of drugs that prolong QT-interval * Women who are pregnant, breast-feeding or without reliable contraception * Participation in another clinical drug study

Design outcomes

Primary

Measure	Time frame	Description
Average FEV1	12 h	FEV1 determined from serial spirometry and calculated on the basis of area under the curve

Secondary

Measure	Time frame	Description
Maximum FEV1	12 h	Maximum FEV1 over the 12-hour serial assessments
FEV1 at 12 h	12 h	FEV1 at 12 hours post-dose

Countries

Bulgaria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026