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Chronic Obstructive Pulmonary DiseasePhase 3FRINCT03268226

Functional Respiratory Imaging Study (FRI)

A Phase 3 study testing Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 5 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effect of inhaled extrafine CHF5993 pMDI on airway volumes, and resistance, by Functional Respiratory Imaging (FRI), in COPD patients Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesin 2 countries
Study dates
20 Nov 2017to 30 Jan 2019
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject's written informed consent obtained prior to any study-related procedure.
  • Male or Female COPD patients aged ≥ 40 years.
  • Smoking history: of at least 10 pack-years (pack-year= number of cigarettes per day x number of years/20).
  • Smoking status: current or ex-smokers. Previous smokers are defined as those who have stopped smoking for at least 24 weeks prior to screening visit. (Pipe and/or cigar and/or e-cigarettes smoking cannot be used to calculate pack-year history). If the subjects undergo smoking cessation therapy, it must be completed 3 months prior to study entry.
  • Patients with documented COPD at least 12 months according to GOLD 2017.
  • Post-bronchodilator (BD) decreased Tiffeneau index: FEV1/FVC < 0.70.
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  • Patients who present post- BD FEV1 less than 50 % of predicted.
  • Patients who present (Functional residual capacity) FRC ≥120% predicted.
  • Patients who present CAT assessment ≥10.
  • Patients on stable respiratory medications for at least 3 months prior to screening with non extrafine extemporary triple combination. The possible combination therapies prior to screening are:
  • fluticasone plus salmeterol plus tiotropium
  • fluticasone plus salmeterol plus glycopyrronium
  • fluticasone plus salmeterol plus umeclidinium
  • fluticasone plus vilanterol plus tiotropium
  • fluticasone plus vilanterol plus glycopyrronium
  • fluticasone plus vilanterol plus umeclidinium;
  • Body Mass Index (BMI) between 18.0 and 32.0 kg/m2 (extremes included) at the screening visit..
  • Ability to understand the study procedures and the risks involved and ability to be trained with pMDI training inhalers to use the devices correctly.
  • 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 visit or
  • WOCBP with non-fertile male partners (contraception is not required in this case).
  • For the definition of WOCBP and of fertile men and the list of highly effective birth control methods, refer the CTFG guidance for more detailed information
  • Female patients of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile; e.g. amenorrehic for ≥12 consecutive months without alternative medical cause). Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy (40). If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).

Who cannot join

  • Pregnant or lactating women.
  • Patients with history or current diagnosis of asthma.
  • Medical history or current diagnosis of allergic rhinitis or atopy (atopy which may have risen contra-indications or impacted the efficacy of the study treatment according to Investigator's judgment).
  • Patients requiring use of the following medications:
  • Systemic steroids for COPD exacerbation in the 4 weeks prior to screening;
  • Patients with a moderate or severe COPD exacerbation [i.e. resulting in the use of systemic corticosteroids (oral/IV/IM) and/or or antibiotics or need for hospitalisation within 6 weeks prior to screening];
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  • A course of antibiotics for COPD exacerbation longer than 7 days in the 4 weeks prior to screening;
  • c-Phosphodiesterase-4 (PDE-4) inhibitors 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;
  • Patients treated with non-cardio-selective β-blockers in the week prior to screening.
  • Patients treated with long-acting anti-histamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study.
  • 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 treatment according the Investigator's judgment. (This could include but is not limited to α-1 antitrypsin deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial lung disease).
  • Lung cancer or history of lung cancer: patients with a diagnosis of lung cancer or a history of lung cancer.
  • Lung resection: subjects with a history of lung volume resection.
  • Subjects who have a cardiovascular condition such as, but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, acute ischemic heart disease in the last year prior to study screening, which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator's judgment; history of atrial fibrillation, history of sustained and non sustained cardiac arrhythmias diagnosed within 24 weeks prior to study entry not controlled with therapy.
  • ECG criteria: any clinically significant abnormal 12-lead ECG that in the Investigator's opinion would affect the efficacy or safety evaluation or place the patients at risk. Male patients with a QTcF >450ms and female patients with a QTcF >470ms at screening and/or baseline visits are not eligible.
  • Medical history or current diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy or bladder neck obstruction that in the opinion of the Investigator would have prevented use of anticholinergic agents.
  • History of hypersensitivity to M3 antagonists, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the study which may raise contra-indications or impacted the efficacy of the study treatment according to the Investigator's judgment.
  • Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may have impacted the efficacy or the safety of the study treatment according to Investigator's judgment.
  • Patients with serum potassium levels < 3.5 mEq/L (or 3.5 mmol/L).
  • Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; uncontrolled gastrointestinal disease (e.g. active peptic ulcer); uncontrolled neurological disease; uncontrolled hematological disease; uncontrolled autoimmune disorders, or other which may impact the feasibility of the results of the study according to Investigator's judgment.
  • History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening.
  • Drugs with hepatoxic potential: Patients receiving treatment with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) within the previous 3 months before the screening visit.
  • Changes in dose, schedule, formulation or product of oral xanthine derivatives (e.g. Theophylline) in the month prior screening visit.
  • Participation in an investigational trial: patients who have received any investigational drug within the 30 days (60 days for biologics) before the screening visit or a more appropriate time as determined by the investigator (e.g. approximately 5 half-lives of the investigational drug whatever is longer).
  • Treatment with strong CYP3A inhibitors (e.g. erythromycin, itraconazole) within 4 weeks prior to study entry.
  • Serology at the screening positive for HIV1 or HIV2 and positive results for Hepatitis which indicates acute or chronic Hepatitis B (i.e. positive HB surface antigen HBsAg, positive and/or positive HB core antibody anti-HBc) or Hepatitis C (positive HCV antibody).

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Belgium4 sites

  • SGS CPU Antwerpen

    Antwerp

  • AZ Saint-Maarten

    Duffel

  • Centre medical Erpent - Residence

    Erpent

  • Heilige Familie AZ

    Reet

Other trials in Belgium

Hungary1 site

  • National Koranyi Institute for TB and Pulmonology

    Budapest

Other trials in Hungary

About this study

Official title: Open Label, Prospective, Exploratory Study to Investigate the Effect of Inhaled CHF5993 pMDI on Central and Peripheral Airway Dimensions in COPD Patients by Functional Respiratory Imaging

The purpose of this study is to evaluate the effect of inhaled extrafine CHF5993 pMDI on airway volumes, and resistance, by Functional Respiratory Imaging (FRI), in COPD patients

Being tested
Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium
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/GlycopyrroniumDrug

    An inhaled dose of CHF 5993 pMDI 100+6+12.5 μg twice a day (Total daily dose: BDP 400 μg / FF 24 μg / GB 50 μg)

Study groups in NCT03268226
Study groupRoleWhat they receive
CHF5993ExperimentalBeclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide administered via pMDI
Receives: Drug: Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium

What is being measured

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

  1. Specific image-based airway volumes (siVaw)

    CT-based airway volumes normalized by the lung volume

    Measured: Change from baseline at 24 Weeks.

  2. Specific image-based airway resistance (siRaw)

    CFD-based airway resistance normalized by the lung volume

    Measured: Change from baseline at 24 Weeks.

Secondary outcomes (14)

  1. Internal Airflow Distribution

    calculated using thorax HRCT

    Measured: On Week 0, Week 12, and on Week 24

  2. Air Trapping

    calculated using thorax HRCT

    Measured: On Week 0, Week 12, and on Week 24

  3. Emphysema

    calculated using thorax HRCT

    Measured: On Week 0, Week 12, and on Week 24

  4. Airway Wall Volume

    calculated using thorax HRCT

    Measured: On Week 0, Week 12, and on Week 24

  5. Blood vessel density

    calculated using thorax HRCT

    Measured: On Week 0, Week 12, and on Week 24

  6. Ventilation/perfusion matching

    calculated using thorax HRCT

    Measured: On Week 0, Week 12, and on Week 24

  7. Aerosol Deposition

    calculated using thorax HRCT

    Measured: On Week 0, Week 12, and on Week 24

  8. Functional Dyspnea

    mMRC dyspnea scale

    Measured: On Week 0, Week 12, and on Week 24

  9. Quality of life

    Saint George Respiratory Questionnaire (SGRQ)

    Measured: On Week 0, Week 12, and on Week 24

  10. CAT score

    8-items unidimensional questionnaire

    Measured: On Week 0, Week 12, and on Week 24

  11. Dyspnea

    Borg CR10

    Measured: On Week 0, Week 12, and on Week 24

  12. Dynamic lung volumes

    calculated using spirometry

    Measured: On Week 0, Week 12, and on Week 24

  13. Static lung volumes

    calculated using body plethysmography

    Measured: On Week 0, Week 12, and on Week 24

  14. airway resistances

    calculated using body plethysmography

    Measured: On Week 0, Week 12, and on Week 24

Timeline

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

  1. First posted31 Aug 2017
  2. Study start20 Nov 2017
  3. Primary completion30 Jan 2019
  4. Study completion30 Jan 2019

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03268226
Sponsor's protocol ID
CCD-05993AA1-16
Other IDs
2017-000438-79, 2017
Acronym
FRI
Status last verified
Mar 2020
First submitted
23 Aug 2017
Last updated
4 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 5 sites in 2 countries.

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 23 inclusion and 28 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 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium, Hungary. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Specific image-based airway volumes (siVaw) (time frame: Change from baseline at 24 Weeks.). The study lists 2 primary outcomes in all. 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 NCT03268226.

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 4 Mar 2020.

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