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Chronic Obstructive Pulmonary DiseasePhase 1NCT02975843

Lung Deposition of Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide Administered Via pMDI in Healthy, Asthmatic and COPD Patients

A Phase 1 study testing Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium in people with Chronic Obstructive Pulmonary Disease and Asthma, run by Chiesi Farmaceutici S.p.A..

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

The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled CHF 5993 Administered via pMDI in healthy volunteers… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Obstructive Pulmonary Disease, Asthma
What is being tested?
Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
No sites listed yet
Study dates
21 Nov 2016to 11 Apr 2017
Phase
Phase 1
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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subject's written informed consent obtained prior to any study-related procedure
  • Body mass index (BMI) between 18 and 32 kg/m2
  • Ability to understand the study procedures and the risks involved and ability to be trained to use the devices correctly at screening and pre-dose.
  • Normal vital signs (Diastolic BP 60-90 mmHg, Systolic BP 90-140 mmHg or 90-150 if >45 yrs) at screening and pre-dose.
  • 12-lead digitalised ECG considered as normal: 60 ≤ heart rate ≤ 100 bpm, 120 ms ≤ PR ≤210 ms, QRS ≤ 120 ms, QTcF ≤ 450 ms (male) and ≤ 470 ms (female) at screening and pre-dose
  • Males fulfilling one of the following criteria:
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  • Males with non-pregnant Women of childbearing potential (WOCBP) partners: they and/or their partner of childbearing potential must be willing to use a highly effective birth control method in addition to the male condom from the signature of the informed consent and until 90 days after the follow-up visit. Subjects must not donate sperm during the study and for 90 days after the follow-up visit or
  • Males with pregnant WOCBP partner: they must be willing to use male contraception (condom) from the signature of the informed consent and until 90 days after the follow-up visit. Subjects must not donate sperm during the study and for 90 days after the follow-up visit or
  • Non-fertile male subjects (contraception is not required in this case) or
  • Males with partner not of childbearing potential (contraception is not required in this case).
  • 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 with low user dependency from the signature of the informed consent and until 30 days after the follow-up visit or
  • WOCBP with non-fertile male partners (contraception is not required in this case).
  • Female patients of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges)
  • Additional Inclusion criteria for Healthy /volunteers and Asthmatic patients:
  • Males and females aged 18-55
  • Non- or Ex-smokers who smoked < 5 pack years (pack-years = number of cigarette packs per day times the number of years) and stopped smoking > 1 year
  • Additional Inclusion Criteria only for Healthy volunteers:
  • Lung function within normal limits: FEV1 ≥ 80% of predicted (according to the Global Lung Function Initiative, ERS Task Force Lung Function Reference Vales) and FEV1/FVC ratio > 0.70 at screening
  • Additional Inclusion Criteria only for Asthmatic patients:
  • Pre-bronchodilator 60% ≤ FEV1 ≤ 80% of predicted (according to the Global Lung Function Initiative, ERS Task Force Lung Function Reference Vales) and FEV1/FVC ratio > 0.70 at screening. If this criterion is not met at Screening, the test can be repeated once before Day -1.
  • Positive reversibility test as defined by an increase in FEV1 ≥ 12% and at least 200 ml compared to the initial value 20-30 minutes after inhalation of 400 μg Salbutamol at screening. If this criterion is not met at Screening, the test can be repeated once before Day -1.
  • Additional Inclusion Criteria only for COPD patients:
  • Males and females aged 40-75
  • Current or ex- smokers (stopped smoking > 1 year ) minimum smoking history of 10 pack-years (packyears = number of cigarette packs per day times the number of years)
  • 30% ≤ FEV1 < 50% of predicted and FEV1/FVC < 0.70 after inhalation of 400 μg Salbutamol. If this criterion is not met at Screening, the test can be repeated once before Day -1.

Who cannot join

  • Pregnant or lactating women
  • Documented history of drug abuse (within 12 months before screening) and/or positive urine drug test at screening and/or at treatment period
  • History of hypersensitivity to M3 Antagonists, β2-agonist, corticosteroids or any of the excipients contained in any of the formulations used in the trial;
  • Any clinically relevant abnormal laboratory value at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the result of the study according to the investigator's judgment
  • Clinically relevant and uncontrolled hepatic, gastrointestinal, renal, genitourinary, endocrine, metabolic neurologic, or psychiatric disorder that may interfere with successful completion of this protocol
  • Serology at the screening positive to 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 (HCV antibody);
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  • Subjects with history of sustained and non-sustained cardiac arrhythmias (ECG demonstrated) and subjects with a family history of sudden cardiac death
  • Subjects who have 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
  • 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"
  • Significant blood loss ≥ 400 ml within 3 months prior screening and between screening and Day 1;
  • Participation in another clinical trial with an investigational drug in the previous 3 months before the administration of the study drug; a longer and more appropriate time could be considered by the principal investigator based on the elimination of the half-life and/or long term toxicity of the previous investigational drug;
  • Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
  • Unsuitable veins for repeated venipuncture
  • Any not allowed concomitant medication
  • Additional Exclusion criteria for Healthy volunteers and Asthmatic patients:
  • Current use of any nicotine or nicotine replacement product
  • Additional Exclusion criteria for Asthmatic and COPD patients:
  • Use of systemic steroids in the 4 weeks prior to screening and between screening and Day 1 (injectable depot steroids 6 weeks)
  • Life-threatening/unstable respiratory status including upper or lower respiratory tract infection, within the previous 30 days before screening and between screening and Day 1
  • Requirement for continuous oxygen therapy (supplemental oxygen not exceeding 2 l/min, at night only and/or during exercise is allowed)
  • Additional Exclusion criteria only for asthmatic patients:
  • Change in dose or type of any medications for asthma within 4 weeks prior to the screening visit
  • Asthma exacerbation within the 4 weeks prior screening and between screening and Day 1
  • History of COPD or any chronic respiratory disease other than Asthma
  • Additional Exclusion criteria only for COPD patients:
  • Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit
  • COPD exacerbation within the 4 weeks prior screening and between screening and Day 1
  • History of asthma or any chronic respiratory disease other than COPD

About this study

Official title: Open Label, Uncontrolled, Non-randomized, Single Dose, Scintigraphic Study to Investigate Lung Deposition of Inhaled 99mTc Radiolabelled CHF5993 pMDI in Healthy Volunteers, Asthmatic and COPD Patients

The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled CHF 5993 Administered via pMDI in healthy volunteers, asthmatic and COPD patients.

Being tested
Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Asthma

What participants receive

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

  • Beclometasone dipropionate/Formoterol Fumarate/GlycopyrroniumDrug

    Also called CHF5993 pMDI

    single inhalation of 99mTc radiolabelled CHF 5993 pMDI (4 puffs for a total dose of: Beclometasone diproprionate (BDP) 400 μg, Formoterol fumarate (FF) 24 μg, Glycopirronium bromide (GB) 50 μg)

Study groups in NCT02975843
Study groupRoleWhat they receive
CHF5993Experimental99mTc Radiolabelled Beclometasone 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. Intrapulmonary Lung deposition expressed as % of nominal dose

    Calculated using the individual Gamma camera images

    Measured: Immediately after dosing

Secondary outcomes (10)

  1. Distribution of lung deposition

    Calculated using the individual Gamma camera images

    Measured: Immediately after dosing

  2. Extrathoracic deposition

    Calculated using the individual Gamma camera images

    Measured: Immediately after dosing

  3. Exhaled activity

    Calculated using the individual Gamma camera images

    Measured: Immediately after dosing

  4. BDP/B17MP, Formoterol, and GB Area under curve (AUC) 0-t

    Calculated through plasma samples for PK evaluation

    Measured: the area under the plasma concentration-time curve from 0 to the last quantifiable concentration. Over 24h

  5. BDP/B17MP, Formoterol, and GB Area under curve (AUC) 0-30min

    Calculated through plasma samples for PK evaluation

    Measured: area under the plasma concentration-time curve from 0 to 30 min post-dose

  6. BDP/B17MP, Formoterol, and GB area under the curve (AUC) 0-∞

    Calculated through plasma samples for PK evaluation

    Measured: area under the curve extrapolated to infinity over 24h

  7. BDP/B17MP, Formoterol, and GB Peak Plasma Concentration (Cmax)

    Calculated through plasma samples for PK evaluation

    Measured: the value of the maximum plasma concentration will be obtained directly from the experimental data without interpolation. Over 24h

  8. BDP/B17MP, Formoterol, and GB tmax

    Calculated through plasma samples for PK evaluation

    Measured: time of the maximum plasma concentration will be obtained directly from the experimental data without interpolation. Over 24h

  9. BDP/B17MP, Formoterol, and GB t½

    Calculated through plasma samples for PK evaluation

    Measured: the terminal (apparent elimination) half-life over 24h

  10. lung function assessment

    Calculated using spirometry

    Measured: Over 24 h post dose

Timeline

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

  1. First posted29 Nov 2016 (estimated)
  2. Study start21 Nov 2016
  3. Primary completion21 Mar 2017
  4. Study completion11 Apr 2017

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02975843
Sponsor's protocol ID
CCD-05993AA1-15
Other IDs
2016-001088-35, 2016
Status last verified
Jun 2017
First submitted
15 Nov 2016
Last updated
23 Jun 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium in people with Chronic Obstructive Pulmonary Disease and Asthma, 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 26 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 23 Jun 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Intrapulmonary Lung deposition expressed as % of nominal dose (time frame: Immediately after dosing). 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 NCT02975843.

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 23 Jun 2017.

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