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Trial record 17 of 1664 for:    ( Map: Bulgaria )

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

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ClinicalTrials.gov Identifier: NCT02308098
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh Drug: Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh Drug: Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Drug: Symbicort Turbuhaler 320/9 ug/inhalation 1inh Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh Drug: Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh Drug: Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Average FEV1 [ Time Frame: 12 h ]
    FEV1 determined from serial spirometry and calculated on the basis of area under the curve


Secondary Outcome Measures :
  1. Maximum FEV1 [ Time Frame: 12 h ]
    Maximum FEV1 over the 12-hour serial assessments

  2. FEV1 at 12 h [ Time Frame: 12 h ]
    FEV1 at 12 hours post-dose



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308098


Locations
Bulgaria
Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD
Ruse, Bulgaria
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Hristo Metev, MD Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT02308098     History of Changes
Other Study ID Numbers: 3103013
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Formoterol Fumarate
Budesonide
Bronchodilator Agents
Budesonide, Formoterol Fumarate Drug Combination
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists