Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT04078126

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.

A Phase 3 study testing BFF and Symbicort Turbuhaler in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 4 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: BFF and Symbicort Turbuhaler
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 4 sitesGermany
Study dates: 10 Sep 2019to 30 Dec 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

Germany4 sites

Research Site
Frankfurt am Main, 60389
Research Site
Gauting, 82131
Research Site
Hanover, D-30173
Research Site
Landsberg, 86899

Other trials in Germany

About this study

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 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.

Read the 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

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: BFF, Symbicort Turbuhaler
Keywords: COPD
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BFFCombination product
Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler)
Symbicort TurbuhalerCombination product
Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler)

Study groups in NCT04078126
Study group	Role	What they receive
Budesonide and formoterol fumarate (MDI BFF)	Experimental	Subject treated with MDI BFF followed by washout period Receives: Combination Product: BFF
Symbicort Turbuhaler	Active comparator	Subject treated with Symbicort followed by washout period Receives: Combination Product: Symbicort Turbuhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Within 4 Hours Post-dose Following 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.
Measured: baseline and 4 hours post dose after 1 week of treatment

Secondary outcomes (8)

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
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).
Measured: baseline and 4 hours post dose after 1 week of treatment
Change From Baseline in Pre-dose FEV1 Following 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.
Measured: baseline and after 1 week of treatment
Change From Baseline in 2-hour Post-dose Inspiratory Capacity (IC) Following 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.
Measured: 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
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.)
Measured: 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
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.)
Measured: baseline and after 1 week of treatment
Change From Baseline in Pre-dose PIF (Resistance Set Equal to ELLIPTA) Following 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.)
Measured: baseline and after 1 week of treatment
Change From Baseline in 2-hour Post-dose FEV1 Following the First Dose
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.
Measured: 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
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.
Measured: baseline and 2 hours post dose after the first dose of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 201930 Dec 2020

First posted4 Sep 2019
Study start10 Sep 2019
Primary completion30 Dec 2020
Study completion30 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04078126
Sponsor's protocol ID: D5980C00023
Other IDs: 2019-001801-26, 2019
Status last verified: Feb 2022
First submitted: 2 Sep 2019
Last updated: 18 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 35815354

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04078126
Acronym / sponsor ID: D5980C00023
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 10 Sep 2019 (actual)
Primary completion: 30 Dec 2020 (actual)
Study completion: 30 Dec 2020 (actual)
First posted: 4 Sep 2019 (actual)
Results: Posted 18 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Budesonide and formoterol fumarate (MDI BFF)	Experimental	Combination Product: BFFSubject treated with MDI BFF followed by washout period
Symbicort Turbuhaler	Active comparator	Combination Product: Symbicort TurbuhalerSubject treated with Symbicort followed by washout period

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BFFTreatment with budesonide and formoterol furmate MDI (metered-dose inhaler)	Combination product	Budesonide and formoterol fumarate (MDI BFF)
Symbicort TurbuhalerTreatment with budesonide and formoterol furmate DPI (dry-powder inhaler)	Combination product	Symbicort Turbuhaler

Primary outcome

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.

8 secondary outcomes

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
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 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 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 (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 ELLIPTA) Following 1 Week of Treatment
Time frame: 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 IC Following the First Dose
Time frame: baseline and 2 hours post dose after the first dose of treatment

Results and safety

Results posted to the registry on 18 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BFF MDI/Symbicort Turbuhaler	18	18
Symbicort Turbuhaler/BFF MDI	17	17

Primary outcome: 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. Least squares mean (95% Confidence Interval). Unit: L

Measure	BFF MDI n = 30	Symbicort Turbuhaler n = 30
Value	0.256 (0.190 to 0.322)	0.274 (0.208 to 0.340)

BFF MDI vs Symbicort Turbuhaler: Mean Difference (Final Values): -0.017 (95% CI -0.054 to 0.020), p = 0.3450, ANCOVA

Population analysed: Modified Intent-to-treat (mITT) Population included all patients who were randomized to treatment and received at least one dose of study treatment with post-baseline spirometry data from both treatment periods at Visits 4 and 6. Patients with data judged to be impacted by important protocol deviations were excluded. Patients discontinued and restarted due to the study having been put on hold for the COVID-19 pandemic used the instance of enrollment after they restarted.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Non-serious adverse events were monitored/assessed from Randomization throughout the Treatment Period and including the washout and follow-up periods, a maximum of 6 weeks. Serious adverse events were recorded from the time of signing of the informed consent, through Run-in, Treatment Period, including washout, and follow-up period, a maximum of 9 weeks.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BFF MDI	0 of 33 (0%)	1 of 33 (3%)	0 of 33
Symbicort Turbuhaler	0 of 35 (0%)	1 of 35 (2.9%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35815354Huber 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.
The CSP redacted.Link provided by the sponsor.
the SAP redacted.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bärbel Huber, Dr. principal investigator

2601

Heiner Steffen, Dr. principal investigator

2602

Claus Keller, Dr. principal investigator

2603

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BFF and Symbicort Turbuhaler in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 4 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04078126, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.