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COPDPhase 4NCT04671355

TRIMBOW® and RELVAR® on Lung Stiffness Reduction Assessed Through Forced Oscillation Technique in Patients With COPD

A Phase 4 study testing Beclometasone Dipropionate / Formoterol Fumarate / Glycopyrronium 100/6/10 mcg and Fluticasone Furoate / Vilanterol Trifenatate 100/25 mcg in people with COPD, run by Chiesi Farmaceutici S.p.A..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Efficacy of TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on lung stiffness reduction assessed through area under the reactance curve (AX) using oscillometry in chronic obstructive pulmonary disease (COPD). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
COPD
What is being tested?
Beclometasone Dipropionate / Formoterol Fumarate / Glycopyrronium 100/6/10 mcg and Fluticasone Furoate / Vilanterol Trifenatate 100/25 mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
4 Oct 2021to 18 Feb 2022
Phase
Phase 4
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient's written informed consent obtained prior to any study related procedures.
  • Male or female patients aged 40 years and above.
  • Patients with established diagnosis of COPD at least 12 months prior to the screening visit (according to GOLD Report, revised 2019). Patients with a diagnosis of Asthma COPD Overlap Syndrome (ACOS) and with a current diagnosis of atopy or allergic rhinitis based on their medical history and investigator judgement will be also eligible for inclusion.
  • Current smokers or ex-smokers, who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years [pack-years = (number of cigarettes per day x number of years)/20]. If patients underwent any kind of smoking cessation therapy, it should be finished at least 2 months prior to screening.
  • A post-bronchodilator FEV1 <60 % of the predicted normal value and a post-bronchodilator FEV1/FVC < 0.7 within 30 min after 4 puffs (4 x 100 µg) of salbutamol pMDI.
  • If this criterion is not met at screening, the test can be repeated once before randomisation.
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  • Patients under double or triple therapy for at least 2 months prior to screening visit in stable doses and regimens with either:
  • inhaled corticosteroids/long-acting β2-agonist combination (ICS/LABA) (fixed or free), or
  • inhaled corticosteroids/long-acting muscarinic antagonist free combination (ICS/LAMA), or
  • Inhaled long-acting β2-agonist / long-acting muscarinic antagonist (LABA/LAMA) (fixed or free), or
  • fixed or free combination of an inhaled corticosteroid /long-acting β2-agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA)
  • A cooperative attitude and ability to correctly use the study inhalers and spacer.
  • Female patients must be either of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile) or physiologically capable of becoming pregnant (i.e. women of childbearing potential (WOCBP) fulfilling one of the following criteria:
  • WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up contact or
  • WOCBP with non-fertile male partners (contraception is not required in this case).For the definition of WONCBP, WOCBP, fertile men, and the list of highly effective birth control methods, refer to Appendix 3 (or section 4.1 of the CTFG guidance).
  • Any postmenopausal women (physiologic menopause defined as "12 consecutive months of amenorrhea") or women permanently sterilized (e.g. bilateral oophorectomy, hysterectomy or bilateral salpingectomy) may be enrolled in the Study.

Who cannot join

  • Pregnant or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential) UNLESS are willing to use one or more of the highly effective birth control method as reported in Appendix 3 (or section 4.1 of the CTFG guidance).
  • Diagnosis of asthma.
  • Patients requiring use of the following medications:
  • A course of systemic steroids longer than 3 days for COPD exacerbation in the 4 weeks prior to screening.
  • A longer than 7-day course of antibiotics for the treatment of COPD exacerbation in the 4 weeks prior to screening.
  • Use of antibiotics for a lower respiratory tract infection (e.g pneumonia) in the 4 weeks prior to screening.
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  • COPD exacerbation requiring prescriptions of systemic corticosteroids and/or antibiotics or hospitalization during the run-in period.
  • Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
  • Known respiratory disorders other than COPD which may impact the efficacy of the study drug according the investigator's judgment. This can include but is not limited to alfa-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease.
  • Patients who have clinically severe cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV, left ventricular failure, acute myocardial infarction, not controlled arrhythmia etc.), which may impact the efficacy or the safety of the study drug according to the investigator's judgement
  • An abnormal and clinically significant 12-lead ECG which may impact the safety of the patient according to investigator's judgement. Patients whose electrocardiogram (ECG) (12 lead) shows QTcF >450 ms for males or QTcF >470 ms for females at screening or at randomisation visits are not eligible. The QTcF criterion should not be applicable to patients with pacemaker or permanent atrial fibrillation.
  • Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of anticholinergic agents.
  • History of hypersensitivity to anticholinergics, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement.
  • Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator's judgement.
  • Unstable concurrent disease: e.g. fever, uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); uncontrolled neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the efficacy or the safety of the study drug according to investigator's judgment.
  • History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit.
  • Participation in another clinical trial where investigational drug was received less than 30 days or 5 half-lives whichever is longer prior to screening visit

About this study

Official title: A Phase IV, Open Label, Multicentre, Randomised, 2-way Cross-over Exploratory Clinical Trial Comparing TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on Lung Stiffness Reduction Assessed Through Area Under the Reactance Curve (AX) in COPD.

Efficacy of TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on lung stiffness reduction assessed through area under the reactance curve (AX) using oscillometry in chronic obstructive pulmonary disease (COPD).

Read the detailed description

An open label, multicentre, randomised, 2-way cross-over exploratory clinical trial comparing a fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrronium administered via pMDI (TRIMBOW®) and a fixed combination of fluticasone furoate plus vilanterol administered via DPI (RELVAR® ELLIPTA®) on lung stiffness reduction assessed through area under the reactance curve (AX) using forced oscillation technique (FOT) in patients with chronic obstructive pulmonary disease (COPD).

Conditions
COPD
Being tested
Beclometasone Dipropionate / Formoterol Fumarate / Glycopyrronium 100/6/10 mcg, Fluticasone Furoate / Vilanterol Trifenatate 100/25 mcg
Keywords
Small Airways Disorders and Forced Oscillation Technique
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.

  • Beclometasone Dipropionate / Formoterol Fumarate / Glycopyrronium 100/6/10 mcgDrug

    Pressurized metered dose inhaler

  • Fluticasone Furoate / Vilanterol Trifenatate 100/25 mcgDrug

    Dry powder inhaler

Study groups in NCT04671355
Study groupRoleWhat they receive
TrimbowExperimentalPressurized metered dose inhaler
Receives: Drug: Beclometasone Dipropionate / Formoterol Fumarate / Glycopyrronium 100/6/10 mcg
RelvarActive comparatorDry powder inhaler
Receives: Drug: Fluticasone Furoate / Vilanterol Trifenatate 100/25 mcg

What is being measured

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

  1. Oscillometry - Reactance (AX)

    Area under the curve of Reactance (AX) 5-120 minutes post-dose

    Measured: 4 weeks

Secondary outcomes (7)

  1. Oscillometry - Resistance at 5 Hertz (R5)

    Change from baseline 5-120 minutes post-dose

    Measured: 4 weeks

  2. Spirometry - Forced Expiratory Volume in the first second

    Change from baseline in pre-dose and post-dose (30, 60 and 120 minutes post-dose)

    Measured: 4 weeks

  3. Health status

    Change from baseline in COPD Assessment Test (CAT) score

    Measured: 4 weeks

  4. Safety monitoring - incidence of adverse events (AEs) and adverse drug reactions (ADRs)

    Recording of AEs and ADRs

    Measured: Overall study period and by Treatments (4 weeks)

  5. Oscillometry - Resistance at 19 Hertz (R19) and 20 Hertz (R20)

    Change from baseline 5-120 minutes post-dose

    Measured: 4 weeks

  6. Oscillometry - Resonance frequency (RF)

    Change from baseline 5-120 minutes post-dose

    Measured: 4 weeks

  7. Spirometry - Forced Vital Capacity

    Change from baseline in pre-dose and post-dose (30, 60 and 120 minutes post-dose)

    Measured: 4 weeks

Timeline

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

  1. First posted17 Dec 2020
  2. Study start4 Oct 2021 (estimated)
  3. Primary completion22 Dec 2021 (estimated)
  4. Study completion18 Feb 2022 (estimated)

Why it stopped: Continuing delays due to COVID-19 pandemic

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04671355
Sponsor's protocol ID
CLI-05993AA1-21
Other IDs
2019-002744-24, 2019
Status last verified
Jan 2022
First submitted
28 Oct 2020
Last updated
3 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Beclometasone Dipropionate / Formoterol Fumarate / Glycopyrronium 100/6/10 mcg and Fluticasone Furoate / Vilanterol Trifenatate 100/25 mcg in people with COPD, run by Chiesi Farmaceutici S.p.A..

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 16 inclusion and 17 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: withdrawn, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 withdrawn before enrolling participants, so there are no results.

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?

Oscillometry - Reactance (AX) (time frame: 4 weeks). 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 NCT04671355.

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 3 Feb 2022.

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