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CompletedNCT02308098BUFODILUpdated Jun 30, 2015

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

A Phase 3 interventional study of Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh and Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh in Asthma, sponsored by Orion Corporation, Orion Pharma. Completed at 1 site in Bulgaria. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-30.

Sponsored by Orion Corporation, Orion Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Asthma
03

In context

Lead sponsor

Orion Corporation, Orion Pharma is the lead sponsor of 100 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh

    Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh

    Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh · Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh

  • Experimental
    Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh

    Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh

    Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh · Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh

  • Experimental
    Symbicort Turbuhaler 320/9 ug/inhalation 4 inh

    Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 4 inh

    Drug: Symbicort Turbuhaler 320/9 ug/inhalation 4 inh · Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh

  • Experimental
    Symbicort Turbuhaler 320/9 ug/inhalation 1 inh

    Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Placebo Budesonide/formoterol Easyhaler 320/9 ug/inhalation 1 inh

    Drug: Symbicort Turbuhaler 320/9 ug/inhalation 1inh · Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh

Interventions

  • 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 Symbicort Turbuhaler 320/9 ug/inhalation 4 inh
  • 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
06

What researchers measure

Primary outcomes

  1. Average FEV1

    FEV1 determined from serial spirometry and calculated on the basis of area under the curve

    Time frame: 12 h

Secondary outcomes

  1. Maximum FEV1

    Maximum FEV1 over the 12-hour serial assessments

    Time frame: 12 h

  2. FEV1 at 12 h

    FEV1 at 12 hours post-dose

    Time frame: 12 h

07

Study locations

1 site
  • Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
    Ruse, Bulgaria
08

References and documents

Publications

  • Lahelma S, Vahteristo M, Metev H, Taseva M, Stamatova N, Bartha A, Schlezak J, Sairanen U. Equivalent bronchodilation with budesonide/formoterol combination via Easyhaler and Turbuhaler in patients with asthma. Respir Med. 2016 Nov;120:31-35. doi: 10.1016/j.rmed.2016.09.016. Epub 2016 Sep 25. PubMed 27817813 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02308098
Lead sponsor
Orion Corporation, Orion Pharma
Responsible party
Sponsor
First posted
Dec 4, 2014
Start date
Dec 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jun 30, 2015

Study contacts

Hristo Metev, MD
principal investigator · Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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