Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Budesonide and Formoterol Fumarate Inhalation Aerosol
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Concentration unit: µ
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Individuals who have a physician diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS). 3. 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. 4. A post-bronchodilator FEV1/FVC of =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Current diagnosis of asthma, in the opinion of the Investigator. 2. 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. 3. A moderate or severe exacerbation of COPD within 6 weeks prior to randomization (Visit 3). 4. Need for mechanical ventilation within 3 months prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of Budesonide/ Formoterol Fumarate (BFF) MDI administered with a spacer relative to Symbicort Turbuhaler on lung function.;Secondary Objective: To assess the effects of BFF MDI administered with a spacer relative to Symbicort Turbuhaler on additional measures of lung function.;Primary end point(s): Peak change from baseline in FEV1 within 4 hours post-dose following 1 week of treatment.;Timepoint(s) of evaluation of this end point: Week 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Area under the curve for change from baseline in FEV1 following 1 week of treatment. 2) Change from baseline in pre-dose FEV1 following 1 week of treatment. 3) Change from baseline in 2-hour post-dose inspiratory capacity (IC) following 1 week of treatment, 4) Change from baseline in pre-dose PIF (InCheck Device set to no resistance, resistance set equal to Turbuhaler S, and resistance set equal to ELLIPTA) following 1 week of treatment. 5) Change from baseline in 2-hour post-dose FEV1 following the first dose. 6) Change from baseline in 2-hour post-dose IC following the first dose.;Timepoint(s) of evaluation of this end point: Baseline, day 1 and week 1 | — |
Countries
Germany
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed