Clinical trial NCT04078126: 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.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-09-04
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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

Eligibility 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.

Primary outcomes:
measure: Peak Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Within 4 Hours Post-dose Following 1 Week of Treatment
timeFrame: baseline and 4 hours post dose after 1 week of treatment
Secondary outcomes:
measure: Area Under the Curve for Change From Baseline in FEV1 From Area Under the Curve 0 to 4 Hours (AUC0-4 h) Following 1 Week of Treatment
timeFrame: baseline and 4 hours post dose after 1 week of treatment
measure: Change From Baseline in Pre-dose FEV1 Following 1 Week of Treatment
timeFrame: baseline and after 1 week of treatment
measure: Change From Baseline in 2-hour Post-dose Inspiratory Capacity (IC) Following 1 Week of Treatment
timeFrame: baseline and 2 hours post dose after 1 week of treatment
measure: Change From Baseline in Pre-dose Peak Inspiratory Flow (PIF; InCheck Device Set to no Resistance) Following 1 Week of Treatment
timeFrame: baseline and after 1 week of treatment
measure: Change From Baseline in Pre-dose PIF (Resistance Set Equal to Turbuhaler S) Following 1 Week of Treatment
timeFrame: baseline and after 1 week of treatment
measure: Change From Baseline in Pre-dose PIF (Resistance Set Equal to ELLIPTA) Following 1 Week of Treatment
timeFrame: baseline and after 1 week of treatment
measure: Change From Baseline in 2-hour Post-dose FEV1 Following the First Dose
timeFrame: baseline and 2 hours post dose after the first dose of treatment
measure: Change From Baseline in 2-hour Post-dose IC Following the First Dose
timeFrame: baseline and 2 hours post dose after the first dose of treatment
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: Research Site
city: Gauting
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Landsberg
country: Germany
facility: Research Site
Study officials:
affiliation: 2601
name: Bärbel Huber, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: 2602
name: Heiner Steffen, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: 2603
name: Claus Keller, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: 2604
name: Martin Hoffmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huber B, Keller C, Jenkins M, Raza A, Aurivillius M. Effect of inhaled budesonide/formoterol fumarate dihydrate delivered via two different devices on lung function in patients with COPD and low peak inspiratory flow. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107312. doi: 10.1177/17534666221107312.