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Airway Clearance Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00379028
First received: September 20, 2006
Last updated: January 21, 2011
Last verified: January 2011
History of Changes

September 20, 2006
January 21, 2011
September 2006
Not Provided
Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers
Same as current
Complete list of historical versions of study NCT00379028 on ClinicalTrials.gov Archive Site
  • Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients
  • Correlation between baseline lung function and AUC of steroids after inhalation.
Same as current
Not Provided
Not Provided
 
Airway Clearance Study
A Randomized, Double-blind, Two-way Cross-over Study Evaluating Systemic Bioavailability and Airway Clearance of SymbicortTurbuhaler 320/9mcg vs SeretideDiskus 50/500mcg After Single Inhalations in Patients With COPD and Healthy Volunteers

The purpose of the study is to evaluate how the airways in COPD patients, compared to healthy volunteers, absorb steroid drugs from Symbicort Turbuhaler and Seretide Diskus. The blood concentrations of the steroids will be used as surrogate marker.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Budesonide/Formoterol Turbuhaler
    Other Name: Symbicort
  • Drug: Salmeterol/Fluticasone Diskus
Not Provided
Dalby C, Polanowski T, Larsson T, Borgström L, Edsbäcker S, Harrison TW. The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial. Respir Res. 2009 Oct 31;10:104.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
July 2007
Not Provided

Inclusion Criteria:

  • COPD patients: ≥40 years of age, Diagnosed COPD with symptoms ≥1 year, Pre-bronchodilatory FEV1 ≤55% of PN, Productive cough with expectoration.
  • Healthy volunteers: ≥18 years of age, Healthy, Pre-bronchodilatory FEV1 >80% of PN, Non-smoker

Exclusion Criteria:

  • COPD patients: Current respiratory tract disorder other than COPD, Asthma before 40 years of age, Significant or unstable cardiovascular disorder,
  • Healthy volunteers: Use of any regular medication or therapy, Pregnancy or breast-feeding,
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden,   United Kingdom
 
NCT00379028
D5892C00012, EUDRACT 2006-002412-10
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Christer Hultquist, MD AstraZeneca
Principal Investigator: Tim Harrisson, MD Nottingham University
AstraZeneca
January 2011

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