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NCT04078126 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD)

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.
Sponsor:

AstraZeneca

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.

Condition or disease

Chronic Obstructive Pulmonary Disease (COPD)

Intervention/treatment

BFF

Symbicort Turbuhaler

Phase

PHASE3

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 a Spacer Compared with Symbicort® Turbuhaler® in Subjects with Severe to Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow to assess lung function

Study Type : INTERVENTIONAL
Estimated Enrollment : 35 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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 a Spacer Compared With Symbicort® Turbuhaler® in Subjects With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow
Actual Study Start Date : 2019-09-10
Estimated Primary Completion Date : 2020-12-30
Estimated Study Completion Date : 2020-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key 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 \<0.70 and post-bronchodilator FEV1 of \<50% predicted normal value at Visit 2.
  • 5. A pre-bronchodilator PIF of \<50 L/min using the InCheck Inspiratory Flow Measurement Device set to Turbuhaler S resistance at Visit 2.
  • 6. Current or former smokers with history of at least 10 pack-years of cigarette smoking.
  • Key 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 ending within 6 weeks prior to randomization (Visit 3).
    • 4. Need for mechanical ventilation within 3 months prior to Visit 1.
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.

Location Details

NCT04078126

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Germany,

Research Site

Frankfurt/Main, Germany, 60389

Not yet recruiting

Germany,

Research Site

Gauting, Germany, 82131

Not yet recruiting

Germany,

Research Site

Hannover, Germany, D-30173

Not yet recruiting

Germany,

Research Site

Landsberg, Germany, 86899