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

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ClinicalTrials.gov Identifier: NCT03795350
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief 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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Asthma Drug: Beclometasone dipropionate Formoterol Fumarate Glycopyrronium Bromide Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: TRIMBOW

Experimental: BDP/FF/GB

4 puffs of 99mTc Radiolabelled Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide administered via pMDI

Drug: Beclometasone dipropionate Formoterol Fumarate Glycopyrronium Bromide
single inhalation of 99mTc radiolabelled TRIMBOW pMDI (4 puffs for a total dose of 400mcg BDP, 24mcg FF, 50 mcg GB)




Primary Outcome Measures :
  1. intrapulmonary lung deposition [ Time Frame: immediately after dosing ]
    calculated using individual Gamma camera images


Secondary Outcome Measures :
  1. Intrapulmonary lung distribution of deposition: C/P ratio [ Time Frame: immediately after dosing ]
  2. extrathoracic deposition [ Time Frame: immediately after dosing ]
  3. amount of exhaled drug [ Time Frame: immediately after dosing ]
  4. TRIMBOW pharmacokinetics - (AUC0-t) [ Time Frame: up to 24 hours post dose ]
    Area Under plasma Concentration from 0 to last quantifiable concentration (AUC0-t) for BDP, B17MP, FF and GB

  5. lung function assessment - FEV1, FVC, FEV1/FVC, FEF25%, FEF50%, FEF75% [ Time Frame: up to 24 hours post dose ]
    FEV1, FVC, FEV1/FVC, FEF25%, FEF50%, FEF75%

  6. TRIMBOW pharmacokinetics - (AUC0-30) [ Time Frame: up to 24 hours post dose ]
    area under plasma concentration from 0 to 30 min (AUC0-30) for B17MP, FF and GB

  7. TRIMBOW pharmacokinetics - (Cmax) [ Time Frame: up to 24 hours post dose ]
    Maximum plasma concentration (Cmax) for BDP, B17MP, FF and GB

  8. TRIMBOW - (tmax) [ Time Frame: up to 24 hours post dose ]
    time of the maximum plasma concentration (tmax) for BDP, B17MP, FF and GB

  9. TRIMBOW pharmacokinetics - (AUC0-∞) [ Time Frame: up to 24 hours post dose ]
    area under curve extrapolated to infinity (AUC0-∞) for B17MP, FF and GB

  10. TRIMBOW pharmacokinetics - (t1/2) [ Time Frame: up to 24 hours post dose ]
    terminal half-life (t1/2) for B17MP, FF and GB



Information from the National Library of Medicine

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Ages Eligible for Study:   28 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for all subjects:

  1. Subject's written informed consent obtained prior to any study-related procedure;
  2. 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®
  3. Body Mass Index (BMI) between 18 and 32 kg/m2 extremes inclusive;
  4. Good physical status, determined on the basis of the medical history and a general clinical examination, at screening;
  5. Vital signs within normal limits: Diastolic BP 40-90 mmHg, Systolic BP 90-140 mmHg or 90-160 mmHg if >45 yrs
  6. Males fulfilling one of the following criteria:

    1. 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
    2. 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
    3. Non-fertile male subjects (contraception is not required in this case) or
    4. Males with partner not of childbearing potential (contraception is not required in this case).
  7. WOCBP fulfilling one of the following criteria:

    1. 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
    2. WOCBP with non-fertile male partners (contraception is not required in this case).
  8. 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)
  9. 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:

  1. Male and female subjects aged 28-55 years inclusive;
  2. 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:

  1. Diagnosis of asthma: Established diagnosis of permanent asthma for at least 12 months according to GINA guidelines
  2. Patients with a pre-bronchodilator 60%≤ FEV1 < 80% of the predicted normal value
  3. 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:

  1. Male and female patients aged 40-80 years inclusive
  2. A smoking history of at least 10 pack-years
  3. Current or ex-smokers are eligible.
  4. Established diagnosis of COPD
  5. 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.

Exclusion Criteria:

Inclusion criteria for all subjects:

  1. Pregnant or lactating women;
  2. Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders
  3. Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation
  4. Subjects with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction
  5. Positive HIV1 or HIV2 serology at screening
  6. Blood donation or blood loss less than 2 months prior screening
  7. Participation to another clinical trial where investigational drug was received and last investigations were performed less than 90 days prior to screening;
  8. Documented history of alcohol abuse within 12 months prior to screening or a positive alcohol breath test
  9. Documented history of drug abuse within 12 months prior to screening
  10. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C at screening
  11. 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
  12. Unsuitable veins for repeated venepuncture/cannulation
  13. Intake of non-permitted concomitant medications in the predefined period prior to screening
  14. Radiation exposure, including that from the present study, in the last 12 months
  15. Known intolerance/hypersensitivity or contra-indication to treatment

Additional exclusion Criteria only for Healthy volunteers and Asthmatic patients:

  1. Positive urine test for cotinine at screening or prior Day 1
  2. Current use of any nicotine or nicotine replacement product

Additional exclusion criteria only for Asthmatic and COPD patients:

  1. 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
  2. A diagnosis of lung cancer or a history of lung cancer
  3. A history of lung volume reduction surgery
  4. 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:

  1. History of near fatal asthma, hospitalization for asthma in intensive care unit
  2. 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
  3. Non-persistent asthma:
  4. Treatment with chronic systemic corticosteroids or anti IgE or other monoclonal antibodies
  5. Known respiratory disorders other than asthma

Additional exclusion Criteria only for COPD patients:

  1. Any change in dose, schedule or formulation in the treatment for COPD in the 4 weeks prior to the screening
  2. A concurrent diagnosis of asthma, in the opinion of the investigator
  3. Known respiratory disorder other than COPD that in the Investigator's opinion would affect efficacy and safety evaluation or place the patient at risk.
  4. Oxygen therapy: patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.
  5. Change in dose or type of any medications for COPD within 4 weeks prior to the screening visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795350


Contacts
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Contact: Clinical Trial Info 0039 0521 279715 clinicaltrials_info@chiesi.com

Locations
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United Kingdom
Simbec Research Ltd Recruiting
Merthyr Tydfil, United Kingdom
Contact: Samuel Israel, Dr.         
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.

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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT03795350     History of Changes
Other Study ID Numbers: CLI-05993AA1-20
2017-005030-29 ( EudraCT Number )
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chiesi Farmaceutici S.p.A.:
Lung deposition
Gamma scintigraphy

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Anti-Asthmatic Agents
Respiratory Tract Diseases
Formoterol Fumarate
Beclomethasone
Glycopyrrolate
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents