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

June 29, 2015 updated by: Orion Corporation, Orion Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orion Corporation, Orion Pharma

Investigators

  • Principal Investigator: Hristo Metev, MD, Specialized Hospital for Active Treatment for Pneumophthisiatric Diseases Dr Dimitar Gramatikov-Ruse EOOD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 3, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

June 30, 2015

Last Update Submitted That Met QC Criteria

June 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3103013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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