Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics - Full Text View

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

This study is not yet open for participant recruitment.

Verified by Orion Corporation, Orion Pharma, August 2009

First Received: August 24, 2009 No Changes Posted

Sponsor:	Orion Corporation, Orion Pharma
Information provided by:	Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:	NCT00964535

Purpose

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	Intervention	Phase
Asthma	Drug: budesonide and formoterol 200/6 microg	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Bio-equivalence Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:

Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations [ Time Frame: within 24 h ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	September 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Budesonide/formoterol Easyhaler: Experimental	Drug: budesonide and formoterol 200/6 microg 2 inhalations as a single dose
Charcoal and Budesonide/formoterol EH: Experimental	Drug: budesonide and formoterol 200/6 microg 2 inhalations as a single dose with the concurrent charcoal blockage
Symbicort Turbohaler: Active Comparator	Drug: budesonide and formoterol 200/6 microg 2 inhalations as a single dose
Charcoal and Symbicort Turbohaler: Active Comparator	Drug: budesonide and formoterol 200/6 microg 2 inhalations as a single dose with the concurrent charcoal blockage

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Responsible Party:	Orion Corporation, Orion Pharma ( Ulla Sairanen )
Study ID Numbers:	3103002
Study First Received:	August 24, 2009
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00964535 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Symbicort
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide

Anti-Asthmatic Agents
Glucocorticoids
Hormones
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 09, 2010