- ICH GCP
- US Clinical Trials Registry
- 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.
February 21, 2022 updated by: AstraZeneca
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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
35
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Frankfurt/Main, Germany, 60389
- Research Site
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Gauting, Germany, 82131
- Research Site
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Hannover, Germany, D-30173
- Research Site
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Landsberg, Germany, 86899
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Key Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Budesonide and formoterol fumarate (MDI BFF)
Subject treated with MDI BFF followed by washout period
|
Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler)
|
Active Comparator: Symbicort Turbuhaler
Subject treated with Symbicort followed by washout period
|
Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Within 4 Hours Post-dose Following 1 Week of Treatment
Time Frame: baseline and 4 hours post dose after 1 week of treatment
|
Peak change from baseline in FEV1 within 4 hours post-dose was defined as the maximum of the FEV1 assessments within 4 hours post-dosing at each visit minus baseline, provided that there were at least 2 non-missing values during the first 4 hours post dose.
|
baseline and 4 hours post dose after 1 week of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: baseline and 4 hours post dose after 1 week of treatment
|
FEV1 AUC0-4 was calculated using the trapezoidal rule and was normalized by dividing by the time in hours from dosing to the last measurement included (typically 4 hours).
|
baseline and 4 hours post dose after 1 week of treatment
|
Change From Baseline in Pre-dose FEV1 Following 1 Week of Treatment
Time Frame: baseline and after 1 week of treatment
|
Change from baseline in pre-dose FEV1 following 1 week of treatment was defined as the 45-minute pre-dose value following 1 week of treatment minus baseline.
|
baseline and after 1 week of treatment
|
Change From Baseline in 2-hour Post-dose Inspiratory Capacity (IC) Following 1 Week of Treatment
Time Frame: baseline and 2 hours post dose after 1 week of treatment
|
Change from baseline in 2-hour post-dose IC following 1 week of treatment was defined as the 2-hour post-dose assessment of IC following 1 week of treatment minus baseline IC.
|
baseline and 2 hours post dose after 1 week of treatment
|
Change From Baseline in Pre-dose Peak Inspiratory Flow (PIF; InCheck Device Set to no Resistance) Following 1 Week of Treatment
Time Frame: baseline and after 1 week of treatment
|
Change from baseline in pre-dose PIF (InCheck device set to no resistance) following 1 week of treatment was defined as the pre-dose PIF (InCheck device set to no resistance) following 1 week of treatment minus baseline PIF.
(The InCheck Inspiratory Flow Measurement Device is an inhalation airflow meter that may be set to various resistances similar to marketed inhaler products.
For this measurement, the device was set to no resistance.)
|
baseline and after 1 week of treatment
|
Change From Baseline in Pre-dose PIF (Resistance Set Equal to Turbuhaler S) Following 1 Week of Treatment
Time Frame: baseline and after 1 week of treatment
|
Change from baseline in pre-dose PIF (resistance set equal to Turbuhaler S) following 1 week of treatment was defined as the pre-dose PIF (resistance set equal to Turbuhaler S) following 1 week of treatment minus baseline PIF.
(The InCheck Inspiratory Flow Measurement Device is an inhalation airflow meter that may be set to various resistances similar to marketed inhaler products.
For this measurement, the device was set to resistance equal to the product Turbuhaler S.)
|
baseline and after 1 week of treatment
|
Change From Baseline in Pre-dose PIF (Resistance Set Equal to ELLIPTA) Following 1 Week of Treatment
Time Frame: baseline and after 1 week of treatment
|
Change from baseline in pre-dose PIF (resistance set equal to ELLIPTA) following 1 week of treatment was defined as the pre-dose PIF (resistance set equal to ELLIPTA) following 1 week of treatment minus baseline PIF.
(The InCheck Inspiratory Flow Measurement Device is an inhalation airflow meter that may be set to various resistances similar to marketed inhaler products.
For this measurement, the device was set to resistance equal to the product ELLIPTA.)
|
baseline and after 1 week of treatment
|
Change From Baseline in 2-hour Post-dose FEV1 Following the First Dose
Time Frame: baseline and 2 hours post dose after the first dose of treatment
|
Change from baseline in 2-hour post-dose FEV1 following the 1st dose of treatment was defined as the 2-hour post-dose assessment of FEV1 following the 1st dose of treatment (Visit 3 or 5) minus baseline FEV1.
|
baseline and 2 hours post dose after the first dose of treatment
|
Change From Baseline in 2-hour Post-dose IC Following the First Dose
Time Frame: baseline and 2 hours post dose after the first dose of treatment
|
Change from baseline in 2-hour post-dose IC following the 1st dose of treatment was defined as the 2-hour post-dose assessment of IC following the 1st dose of treatment (Visit 3 or 5) minus baseline IC.
|
baseline and 2 hours post dose after the first dose of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bärbel Huber, Dr., 2601
- Principal Investigator: Heiner Steffen, Dr., 2602
- Principal Investigator: Claus Keller, Dr., 2603
- Principal Investigator: Martin Hoffmann, Dr., 2604
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2019
Primary Completion (Actual)
December 30, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
September 2, 2019
First Submitted That Met QC Criteria
September 2, 2019
First Posted (Actual)
September 4, 2019
Study Record Updates
Last Update Posted (Actual)
March 18, 2022
Last Update Submitted That Met QC Criteria
February 21, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D5980C00023
- 2019-001801-26 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool .
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.
For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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