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
2 other identifiers
interventional
54
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 chronic-obstructive-pulmonary-disease
Started Sep 2006
Shorter than P25 for phase_4 chronic-obstructive-pulmonary-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 20, 2006
CompletedFirst Posted
Study publicly available on registry
September 21, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedJanuary 24, 2011
January 1, 2011
September 20, 2006
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients
Correlation between baseline lung function and AUC of steroids after inhalation.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Research Site
Lund, Sweden
Research Site
Nottingham, United Kingdom
Related Publications (1)
Dalby C, Polanowski T, Larsson T, Borgstrom L, Edsbacker 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(1):104. doi: 10.1186/1465-9921-10-104.
PMID: 19878590DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christer Hultquist, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Tim Harrisson, MD
Nottingham University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 20, 2006
First Posted
September 21, 2006
Study Start
September 1, 2006
Study Completion
July 1, 2007
Last Updated
January 24, 2011
Record last verified: 2011-01