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
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Budesonide/Formoterol Turbuhaler
Drug: Salmeterol/Fluticasone Diskus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients
  • Correlation between baseline lung function and AUC of steroids after inhalation.

Enrollment: 54
Study Start Date: September 2006
Study Completion Date: July 2007
Intervention Details:
    Drug: Budesonide/Formoterol Turbuhaler
    Other Name: Symbicort
    Drug: Salmeterol/Fluticasone Diskus
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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,
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379028

Locations
Sweden
Research Site
Lund, Sweden
United Kingdom
Research Site
Nottingham, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Christer Hultquist, MD AstraZeneca
Principal Investigator: Tim Harrisson, MD Nottingham University
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00379028     History of Changes
Other Study ID Numbers: D5892C00012, EUDRACT 2006-002412-10
Study First Received: September 20, 2006
Last Updated: January 21, 2011
Health Authority: Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Salmeterol
Fluticasone
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 23, 2014