ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics (KINECO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00964535
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma

Brief Summary:
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.

Condition or disease Intervention/treatment Phase
Asthma Drug: budesonide and formoterol 200/6 microg Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bioequivalence Study Comparing Two Budesonide/Formoterol Fumarate Dihydrate Device-metered Dry Powder Inhalers, Budesonide/Formoterol Easyhaler 200/6 µg/Inhalation and Symbicort Turbohaler 200 µg/6 µg/Inhalation
Study Start Date : September 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Budesonide/formoterol Easyhaler Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose
Other Name: Budesonide/formoterol Easyhaler 200/6 microg/inhalation

Experimental: Charcoal and Budesonide/formoterol EH Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose with the concurrent charcoal blockage
Other Name: Budesonide/formoterol Easyhaler 200/6 microg/inhalation

Active Comparator: Symbicort Turbohaler Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose
Other Name: Symbicort Turbohaler 200/6 microg/inhalation

Active Comparator: Charcoal and Symbicort Turbohaler Drug: budesonide and formoterol 200/6 microg
2 inhalations as a single dose with the concurrent charcoal blockage
Other Name: Symbicort Turbohaler 200/6 microg/inhalation




Primary Outcome Measures :
  1. Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations [ Time Frame: within 24 h ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females aged 18-60 years with documented diagnosis of asthma
  • Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value
  • The asthma should be stable on the same regular treatment for at least 4 weeks before screening.

Exclusion Criteria:

  • Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening
  • Respiratory infection within 4 weeks preceding the screening
  • Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide
  • Any disorder or clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the 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): NCT00964535


Locations
United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Study Director: Ulla Sairanen, MSc Orion Corporation, Orion Pharma

Responsible Party: Ulla Sairanen, Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT00964535     History of Changes
Other Study ID Numbers: 3103002
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Charcoal
Bronchodilator Agents
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
Antidotes
Protective Agents