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.

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Combination Product: Symbicort Turbuhaler; Combination Product: BFF

Study type: Interventional

Funder types: Industry

Identifiers

NCT04078126

D5980C00023

2019-001801-26 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 35 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Budesonide and formoterol fumarate (MDI BFF)

Experimental group

Description:

Subject treated with MDI BFF followed by washout period

Treatment:

Combination Product: BFF

Symbicort Turbuhaler

Active Comparator group

Description:

Subject treated with Symbicort followed by washout period

Treatment:

Combination Product: Symbicort Turbuhaler