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

This study has been completed.
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT00964535
First received: August 24, 2009
Last updated: February 12, 2010
Last verified: February 2010

August 24, 2009
February 12, 2010
September 2009
February 2010   (final data collection date for primary outcome measure)
Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations [ Time Frame: within 24 h ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00964535 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioequivalence Study of Budesonide/Formoterol Easyhaler and Symbicort Turbohaler in Asthmatics
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: budesonide and formoterol 200/6 microg
    2 inhalations as a single dose
    Other Name: Budesonide/formoterol Easyhaler 200/6 microg/inhalation
  • Drug: budesonide and formoterol 200/6 microg
    2 inhalations as a single dose
    Other Name: Symbicort Turbohaler 200/6 microg/inhalation
  • 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
  • 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
  • Experimental: Budesonide/formoterol Easyhaler
    Intervention: Drug: budesonide and formoterol 200/6 microg
  • Experimental: Charcoal and Budesonide/formoterol EH
    Intervention: Drug: budesonide and formoterol 200/6 microg
  • Active Comparator: Symbicort Turbohaler
    Intervention: Drug: budesonide and formoterol 200/6 microg
  • Active Comparator: Charcoal and Symbicort Turbohaler
    Intervention: Drug: budesonide and formoterol 200/6 microg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00964535
3103002
No
Ulla Sairanen, Orion Corporation, Orion Pharma
Orion Corporation, Orion Pharma
Not Provided
Study Director: Ulla Sairanen, MSc Orion Corporation, Orion Pharma
Orion Corporation, Orion Pharma
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP