BronchiectasisPhase 3FORZANCT03846570

Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial

A Phase 3 study testing Formoterol-beclomethasone in people with Bronchiectasis, run by Erasmus Medical Center at 3 sites in Netherlands.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Randomized, double-blind, placebo-controlled study comparing formoterol-beclometason 12/200 mcg BID versus placebo to evaluate the clinical effect on coughing in patients with non-cystic fibrosis (non-CF) bronchiectasis, native to inhaled corticosteroid (ICS) therapy and no history of asthma or chronic obstructive… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bronchiectasis
What is being tested?: Formoterol-beclomethasone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 3 sitesNetherlands
Study dates: 29 Jan 2019to 5 Jul 2022
Phase: Phase 3
Are there results?: None posted in the registry

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptomatic patient (wheezing, cough and dyspnoea);
Proven and documented diagnosis of BE by high resolution computed tomography ;
Stable pulmonary status as indicated by FEV1 (percent of predicted) ≥30%
Stable clinically phase (ie, subjects free from acute exacerbation for at least 6 weeks prior to the start of the study);
Stable regimen of standard treatment as chronic treatment for BE, at least for the past 4 weeks prior to screening. And/or macrolides if used as chronic treatment for BE at least for the past 6 months prior to screening;
Coughing on the majority of days for more than 8 weeks;

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Ability to follow the inhaler device instructions;
Ability to complete questionnaires;
Written informed consent.

Who cannot join

Possible asthma according to the definition of the Global Initiative for Asthma (GINA);
Positive histamine provocation test
Known intolerance for ICS or LABA;
Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
Expected to die within 72 hours after enrolment;
Cigarette smoking history of > 10 pack-years or current smokers;
Other cardiopulmonary conditions (other than bronchiectasis) that could modify spirometric values.

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

Tjeerd van der Veer
Rotterdam, 3015GD
Franciscus Gasthuis & Vlietland
Rotterdam
HagaZiekenhuis
The Hague

Other trials in Netherlands

About this study

Read the detailed description

In the management of non-CF bronchiectasis, bronchodilator treatment (LABA)and use of inhaled corticosteroids (ICS) is still a matter of debate. Previous studies have claimed beneficial effects of ICS (with or without bronchodilator), such as improvement of the HRQL, a reduction in daily sputum volume and/or exacerbation frequency. However, in all previous studies there was no clear exclusion of patients with asthma or COPD, or no use of placebo. The current study will be the first study evaluating the effect of ICS/LABA treatment in non-CF bronchiectasis excluding patients with asthma and COPD.

This is a prospective double-blind randomized controlled trial comparing Formoterol-beclomethasone 12/200 mcg BID versus placebo to evaluate the reduction in cough measured by the Leicester cough questionnaire. Secondary objectives are the improvement of health-related quality of life and symptoms, reduction in sputum production, pulmonary function (FEV1) and the frequency of exacerbation. Furthemore, we will assess the inflammatory response in serum and sputum.

After a wash-out period of 1 month, eligible subjects will be randomized to treatment with formoterol-beclomethasone or matching placebo. All subjects will be treated with the regimen of medication for 3 months. An end-of-study (EOS) visit will be performed after completion of the follow-up period.

Conditions: Bronchiectasis
Being tested: Formoterol-beclomethasone, Placebo
Keywords: Randomized Controlled Trial, Inhaled corticosteroids, Placebo, Cough
Medical subject headings: Bronchiectasis, Cough

What participants receive

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

Formoterol-beclomethasoneDrug
formoterol (fumarate dihydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler
PlaceboDrug
Matching placebo (identically package) administered BID

Study groups in NCT03846570
Study group	Role	What they receive
Formoterol-beclomethasone	Active comparator	Formoterol (fumarate dehydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler. Receives: Drug: Formoterol-beclomethasone
Placebo	Placebo comparator	Matching placebo (identically package) administered BID Receives: Drug: Placebo

What is being measured

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

Clinical effect on coughing
Using the Leicester Cough Questionnaire (LCQ) at baseline and 3 months. The LCQ is a valid, repeatable 19 item self-completed quality of life measure of chronic cough which is responsive to change. Score range: 19-133 (Higher values represent a better outcome.)
Measured: 3 months

Secondary outcomes (7)

Quality of life in patient with bronchiectasis
Mean Change From Baseline in Patient Reported Outcome Quality of Life Questionnaire for Bronchiectasis (QoL-B) Respiratory Symptoms Domain Score (measured at baseline and 3 months).
The QoL-B was a disease-specific questionnaire developed for non-Cystic fibrosis Bronchiectasis. It covers 8 dimensions: physical functioning, role functioning, emotional functioning, social functioning, vitality, treatment burden, health perceptions, and respiratory symptoms. Each dimension was scored separately on a scale of 0 to 100, and higher scores represent better outcomes. For this outcome measure, the respiratory symptoms domain score was reported.
Measured: 3 months
Pulmonary function
Spirometry: FEV1
Measured: 3 months
Exacerbation frequency
The frequency of exacerbation requiring an intervention with systemic antibiotics (oral/intravenous [i.v.])
Measured: 3 months
Sputum production
in mL
Measured: 3 months
Dyspnea score
mMRC (Modified Medical Research Council) Dyspnea Scale. This stratifies severity of dyspnea in respiratory diseases.
Grading from 0 to 4, respectively from 'no dyspnea' to 'very severe dyspnea'.
Measured: 3 months
Incidence of Adverse Events [Safety and Tolerability]).
Incidence of Adverse Events [Safety and Tolerability]).
Measured: 3 months
Sputum culture
Micro organisms isolated during study
Measured: 3 months

Timeline

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

29 Jan 20195 Jul 2022

First posted19 Feb 2019
Study start29 Jan 2019
Primary completion5 Jul 2022
Study completion5 Jul 2022

Why it stopped: Insufficient inclusion rate (due to COVID-19 pandemic)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BronchiectasisStudies of the same condition, open and under way.
More trials run by Erasmus Medical CenterThe 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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03846570
Sponsor's protocol ID: NL61630.078.18
Acronym: FORZA
Status last verified: Feb 2023
First submitted: 14 Feb 2019
Last updated: 1 Mar 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

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

RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
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THERMotherapy Against Persistent Bacterial LUNG Infections
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RecruitingObservational study
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Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Renal Impairment
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Not yet recruitingPhase 3
A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)
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All Bronchiectasis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03846570
Acronym / sponsor ID: FORZA / NL61630.078.18
Conditions: Bronchiectasis
Keywords: Randomized Controlled Trial, Inhaled corticosteroids, Placebo, Cough
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient inclusion rate (due to COVID-19 pandemic)
Enrolment: 34 participants (actual)
Lead sponsor: Erasmus Medical CenterUniversity, hospital or other
Collaborators: Chiesi Farmaceutici S.p.A.
Study start: 29 Jan 2019 (actual)
Primary completion: 5 Jul 2022 (actual)
Study completion: 5 Jul 2022 (actual)
First posted: 19 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Formoterol-beclomethasone	Active comparator	Drug: Formoterol-beclomethasoneFormoterol (fumarate dehydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler.
Placebo	Placebo comparator	Drug: PlaceboMatching placebo (identically package) administered BID

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Symptomatic patient (wheezing, cough and dyspnoea);
Proven and documented diagnosis of BE by high resolution computed tomography ;
Stable pulmonary status as indicated by FEV1 (percent of predicted) ≥30%
Stable clinically phase (ie, subjects free from acute exacerbation for at least 6 weeks prior to the start of the study);
Stable regimen of standard treatment as chronic treatment for BE, at least for the past 4 weeks prior to screening. And/or macrolides if used as chronic treatment for BE at least for the past 6 months prior to screening;

Key exclusion criteria (7 listed)

Possible asthma according to the definition of the Global Initiative for Asthma (GINA);
Positive histamine provocation test
Known intolerance for ICS or LABA;
Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
Expected to die within 72 hours after enrolment;

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
Formoterol-beclomethasoneformoterol (fumarate dihydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler	Drug	Formoterol-beclomethasone
PlaceboMatching placebo (identically package) administered BID	Drug	Placebo

Primary outcome

Clinical effect on coughing
Time frame: 3 months
Using the Leicester Cough Questionnaire (LCQ) at baseline and 3 months. The LCQ is a valid, repeatable 19 item self-completed quality of life measure of chronic cough which is responsive to change. Score range: 19-133 (Higher values represent a better outcome.)

7 secondary outcomes

Quality of life in patient with bronchiectasis
Time frame: 3 months
Pulmonary function
Time frame: 3 months
Exacerbation frequency
Time frame: 3 months
Sputum production
Time frame: 3 months
Dyspnea score
Time frame: 3 months
Incidence of Adverse Events [Safety and Tolerability]).
Time frame: 3 months
Sputum culture
Time frame: 3 months

Results and safety

The study was stopped early (reason given: Insufficient inclusion rate (due to COVID-19 pandemic)). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
Individual participant dataSharing planned: Yes

Related trials for Bronchiectasis

RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
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Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
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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.

Menno M Van der Eerden principal investigator

Erasmus Medical Center

Tjeerd Van der Veer principal investigator

Erasmus Medical Center

3 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 Formoterol-beclomethasone in people with Bronchiectasis, run by Erasmus Medical Center at 3 sites in Netherlands.

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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. 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. Some participants in this study may receive a placebo. 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?

The study was stopped early (reason given: Insufficient inclusion rate (due to COVID-19 pandemic)). Results are not available in the source record.

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?

Clinical effect on coughing (time frame: 3 months). 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 NCT03846570.

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 1 Mar 2023.