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Chronic Obstructive Pulmonary DiseasePhase 1STORMNCT03795350

Lung Deposition of TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients

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

Terminated

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

Official record
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Trial summary

The purpose of this study is to investigate the lung deposition and distribution pattern of TRIMBOW using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled TRIMBOW administered via pMDI in healthy volunteers, asthmatic and COPD patients Read more about this study

Who is it for?
Ages 28 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Obstructive Pulmonary Disease, Asthma
What is being tested?
Beclometasone dipropionate Formoterol Fumarate Glycopyrronium Bromide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited Kingdom
Study dates
14 Jan 2019to 3 Apr 2020
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 28 to 80 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;
  • Ability to understand the study procedures, the risks involved and ability to demonstrate correct use of the inhaler using the AIM™ (Aerosol Inhalation Monitor) Vitalograph®
  • Body Mass Index (BMI) between 18 and 32 kg/m2 extremes inclusive;
  • Good physical status, determined on the basis of the medical history and a general clinical examination, at screening;
  • Vital signs within normal limits: Diastolic BP 40-90 mmHg, Systolic BP 90-140 mmHg or 90-160 mmHg if >45 yrs
  • Males fulfilling one of the following criteria:
Show all 67Show fewer
  • 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).
  • Females 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)
  • 12 -lead digitised Electrocardiogram (12-lead ECG) considered as normal at screening and at Day -1
  • Additional Criteria only for Healthy Volunteers and Asthmatic patients:
  • Male and female subjects aged 28-55 years inclusive;
  • Non- or ex-smokers who smoked < 5 pack years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking > 6 months prior to screening;
  • Additional Inclusion Criteria only for Healthy Volunteers:
  • 1. Lung function measurements within normal limits at screening: FEV1 equal to or more than 80% of predicted
  • Additional Inclusion Criteria only for Asthmatic patients:
  • Diagnosis of asthma: Established diagnosis of permanent asthma for at least 12 months according to GINA guidelines
  • Patients with a pre-bronchodilator 60%≤ FEV1 < 80% of the predicted normal value
  • Patients with a documented reversibility defined as an increase ≥ 12% and 200mL over baseline within 30 min after inhalation of 400µg salbutamol pMDI
  • Additional Inclusion Criteria only for COPD patients:
  • Male and female patients aged 40-80 years inclusive
  • A smoking history of at least 10 pack-years
  • Current or ex-smokers are eligible.
  • Established diagnosis of COPD
  • A post-bronchodilator FEV1 ≤ 50% of the predicted normal value and a post-bronchodilator FEV1/FVC < 0.7 10-15 minutes after 4 puffs (4x100 µg) of Salbutamol pMDI.
  • Pregnant or lactating women;
  • Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders
  • Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation
  • Subjects with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction
  • Positive HIV1 or HIV2 serology at screening
  • Blood donation or blood loss less than 2 months prior screening
  • Participation to another clinical trial where investigational drug was received and last investigations were performed less than 90 days prior to screening;
  • Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test
  • Documented history of drug abuse within 12 months prior to screening
  • Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C at screening
  • 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
  • Unsuitable veins for repeated venepuncture/cannulation
  • Intake of non-permitted concomitant medications in the predefined period prior to screening
  • Radiation exposure, including that from the present study, in the last 12 months
  • Known intolerance/hypersensitivity or contra-indication to treatment
  • Additional exclusion Criteria only for Healthy volunteers and Asthmatic patients:
  • Positive urine test for cotinine at screening or prior Day 1
  • Current use of any nicotine or nicotine replacement product
  • Additional exclusion criteria only for Asthmatic and COPD patients:
  • Use of systemic corticosteroids medication within 4 weeks prior to the screening or slow release corticosteroids within 12 weeks before the screening or prior Day 1
  • A diagnosis of lung cancer or a history of lung cancer
  • A history of lung volume reduction surgery
  • Lower respiratory tract infection that requires use of antibiotics
  • Additional exclusion Criteria only for Healthy volunteers:
  • 1. Subjects with history of breathing problems
  • Additional exclusion Criteria only for Asthmatic patients:
  • History of near fatal asthma, hospitalization for asthma in intensive care unit
  • Any change in dose, schedule or formulation in the treatment of asthma in the 4 weeks prior to the screening visit or prior Day 1
  • Non-persistent asthma:
  • Treatment with chronic systemic corticosteroids or anti IgE or other monoclonal antibodies
  • Known respiratory disorders other than asthma
  • Additional exclusion Criteria only for COPD patients:
  • Any change in dose, schedule or formulation in the treatment for COPD in the 4 weeks prior to the screening
  • A concurrent diagnosis of asthma, in the opinion of the investigator
  • Known respiratory disorder other than COPD that in the Investigator's opinion would affect efficacy and safety evaluation or place the patient at risk.
  • Oxygen therapy: patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
  • Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Simbec Research Ltd

    Merthyr Tydfil

Other trials in United Kingdom

About this study

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

The purpose of this study is to investigate the lung deposition and distribution pattern of TRIMBOW using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled TRIMBOW administered via pMDI in healthy volunteers, asthmatic and COPD patients

Being tested
Beclometasone dipropionate Formoterol Fumarate Glycopyrronium Bromide
Keywords
Lung deposition, Gamma scintigraphy
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 Glycopyrronium BromideDrug

    single inhalation of 99mTc radiolabelled TRIMBOW pMDI (4 puffs for a total dose of 400mcg BDP, 24mcg FF, 50 mcg GB)

Study groups in NCT03795350
Study groupRoleWhat they receive
TRIMBOWExperimentalExperimental: BDP/FF/GB 4 puffs of 99mTc Radiolabelled Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide administered via pMDI
Receives: Drug: Beclometasone dipropionate Formoterol Fumarate Glycopyrronium Bromide

What is being measured

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

  1. intrapulmonary lung deposition

    calculated using individual Gamma camera images

    Measured: immediately after dosing

Secondary outcomes (10)

  1. Intrapulmonary lung distribution of deposition: C/P ratio

    Measured: immediately after dosing

  2. extrathoracic deposition

    Measured: immediately after dosing

  3. amount of exhaled drug

    Measured: immediately after dosing

  4. TRIMBOW pharmacokinetics - (AUC0-t)

    Area Under plasma Concentration from 0 to last quantifiable concentration (AUC0-t) for BDP, B17MP, FF and GB

    Measured: up to 24 hours post dose

  5. lung function assessment - FEV1, FVC, FEV1/FVC, FEF25%, FEF50%, FEF75%

    FEV1, FVC, FEV1/FVC, FEF25%, FEF50%, FEF75%

    Measured: up to 24 hours post dose

  6. TRIMBOW pharmacokinetics - (AUC0-30)

    area under plasma concentration from 0 to 30 min (AUC0-30) for B17MP, FF and GB

    Measured: up to 24 hours post dose

  7. TRIMBOW pharmacokinetics - (Cmax)

    Maximum plasma concentration (Cmax) for BDP, B17MP, FF and GB

    Measured: up to 24 hours post dose

  8. TRIMBOW - (tmax)

    time of the maximum plasma concentration (tmax) for BDP, B17MP, FF and GB

    Measured: up to 24 hours post dose

  9. TRIMBOW pharmacokinetics - (AUC0-∞)

    area under curve extrapolated to infinity (AUC0-∞) for B17MP, FF and GB

    Measured: up to 24 hours post dose

  10. TRIMBOW pharmacokinetics - (t1/2)

    terminal half-life (t1/2) for B17MP, FF and GB

    Measured: up to 24 hours 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 posted7 Jan 2019
  2. Study start14 Jan 2019
  3. Primary completion3 Apr 2020
  4. Study completion3 Apr 2020

Why it stopped: In light of the cessation of non-essential clinical activities at CPU due to the COVID-19 pandemic, the sponsor has determined to terminate the study early.

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
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03795350
Sponsor's protocol ID
CLI-05993AA1-20
Other IDs
2017-005030-29, 2017
Acronym
STORM
Status last verified
May 2022
First submitted
18 Dec 2018
Last updated
6 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Usmani OS, Baldi S, Warren S, Panni I, Girardello L, Rony F, Taylor G, DeBacker W, Georges G. Lung Deposition of Inhaled Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrronium Bromide in Healthy Volunteers and Asthma: The STORM Study. J Aerosol Med Pulm Drug Deliv. 2022 Aug;35(4):179-185. doi: 10.1089/jamp.2021.0046. Epub 2022 Feb 4.

    PubMed 35128939

Questions about this trial

What is this clinical trial studying?

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

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 67 inclusion and 0 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 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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 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 was stopped early (reason given: In light of the cessation of non-essential clinical activities at CPU due to the COVID-19 pandemic, the sponsor has determined to terminate the study early.). 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?

intrapulmonary lung deposition (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 NCT03795350, 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 6 May 2022.

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