Airway Clearance Study
Status and phase
Completed
Phase 4
Conditions
Chronic Obstructive Pulmonary Disease
Treatments
Drug: Budesonide/Formoterol Turbuhaler
Drug: Salmeterol/Fluticasone Diskus
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
54 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
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,
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Triple Blind
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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