Status:
COMPLETED
Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
Study comparing the same drugs as a dual combination product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.
Detailed Description
This is a Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Inhalation Aerosol Administered with...
Eligibility Criteria
Inclusion
- Key
- Subject must be 40 to 80 years of age inclusive, at the time of signing the ICF.
- Individuals who have a physician diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
- Require COPD maintenance therapy: all subjects must be receiving 2 or more inhaled maintenance therapies, including at least 1 long-acting bronchodilator, for the management of their COPD for at least 4 weeks prior to Visit 1.
- A post-bronchodilator FEV1/FVC of \<0.70 and post-bronchodilator FEV1 of \<50% predicted normal value at Visit 2.
- A pre-bronchodilator PIF of \<50 L/min using the InCheck Inspiratory Flow Measurement Device set to Turbuhaler S resistance at Visit 2.
- Current or former smokers with history of at least 10 pack-years of cigarette smoking.
- Key
Exclusion
- Current diagnosis of asthma, in the opinion of the Investigator.
- Other respiratory disorders including known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), immune deficiency disorders, severe neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease.
- A moderate or severe exacerbation of COPD ending within 6 weeks prior to randomization (Visit 3).
- Need for mechanical ventilation within 3 months prior to Visit 1.
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2020
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04078126
Start Date
September 10 2019
End Date
December 30 2020
Last Update
March 18 2022
Active Locations (4)
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1
Research Site
Frankfurt am Main, Germany, 60389
2
Research Site
Gauting, Germany, 82131
3
Research Site
Hanover, Germany, D-30173
4
Research Site
Landsberg, Germany, 86899