Open label, non-randomized, single dose PK/PD study in adolescent asthmatic patients and adult asthmatic patients
- Conditions
- asthmaMedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-002238-35-PL
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 80
1. Patient’s and / or patient legal representative’s/parents’ (where applicable) written informed consent obtained prior to any study related procedure.
2. Ability to understand the study procedures, the risks involved, and ability to be trained to use the pMDI device correctly with AIM™ (Aerosol Inhalation Monitor) Vitalograph®.
3. Male and female adolescents, aged = 12 and < 18 years or male and female adults, aged = 18 and < 65 years.
4. Body mass index (BMI) within the range of 18.0 to 30.0 kg/m2 inclusive.
5. A diagnosis of asthma as defined in the GINA guidelines (updated 2019) 6 months before the screening visit.
6. Male/female adolescent and adult patients with controlled asthma according to GINA guidelines (updated 2019) to allow a wash out period from inhaled BDP of 2 days before study treatment visit.
7. Male/female adolescents and adults with controlled asthma on regular treatment with medium doses of ICS according to GINA guideline alone or in fixed dose combinations with LABA and using short-acting inhaled ß2-agonists as a reliever. Inhaled Corticosteroid Adults and adolescents
8. Adolescents and adults with a forced expiratory volume in one second (FEV1)> 70% of predicted values (% pred) after withholding short acting ß2-agonist treatment for a minimum of 6h prior to screening or 24 hours in case of long acting ß2-agonist.
9. Non-smokers or ex-smokers who smoked < 5 pack years (packyears= the number of cigarette packs per day, times the number of years) and stopped smoking > 1 year prior to screening.
10. Good physical and mental status, determined on the basis of the medical history and a general clinical examination, at screening and at Visit 1 before dosing.
11. Female patients of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile) and female patients of childbearing potential (WOCBP) fulfilling one of the following
criteria:
a. 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
b. WOCBP with non-fertile male partners (contraception is not required in this case).
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Blood donation (equal or more than 450 ml) or blood loss, less than 2 months prior to screening or prior to Visit 1.
2. Abnormal haemoglobin level defined as < 12,0 g/dl in females and < 14,0 g/dl in males.
3. For females only: pregnant and lactating female patients, confirmed by a positive serum pregnancy test at screening or urine pregnancy test at Visit 1 before dosing.
4. Diagnosis of COPD, in adult patients, as defined by the current GOLD guidelines (2019 Report).
5. Positive to HIV1 or HIV2 or positive results for Hepatitis which
indicates acute or chronic Hepatitis B (i.e. positive HB surface antigen HBsAg, positive HB core antibody anti-HBc) or Hepatitis C (positive HCV antibody).
6. Unsuitable veins for repeated venepuncture.
7. Documented history of alcohol abuse within 12 months prior to screening.
8. Documented history of drug abuse within 12 months prior to screening, or positive urine drug test performed at screening or before dosing.
9. Patients who have a positive urine test for cotinine at screening or before dosing.
10. Clinically relevant abnormal laboratory values, suggesting an unknown disease and requiring further clinical investigation.
11. Clinically relevant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol.
12. Known intolerance/hypersensitivity to any of the excipients/components contained in any of the formulations used in the trial.
13. Patients with medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the investigator would prevent use of an anticholinergic.
14. Abnormal 12-lead digitized Electrocardiogram (12-lead ECG) parameter (i.e.: QRS > 120 msec and/or PR > 210 msec and/or HR < 40 bpm and/or HR > 110 bpm and/or QTcF > 450 ms for males or QTcF > 470 ms for females, considering the average from triplicate) or 12-lead ECG evaluated as abnormal clinically significant by the investigator, at screening.
15. Abnormal Blood Pressure (i.e.: Diastolic Blood Pressure > 90 mmHg and/or Systolic Blood Pressure > 140 mmHg, considering the average from triplicate) at screening.
16. Participation in another clinical trial with an investigational drug in the 30 days or 5 half-lives of that investigational drug (whichever is longer) preceding the administration of the study drug; a longer and more appropriate time could be considered by the principal investigator based on the elimination half-life and/or
long-term toxicity of the previous investigational drug.
17. Patients taking enzyme-inducing drugs, enzyme-inhibiting drugs, biologic drugs or any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) in the 3 months before screening or Visit 1.
18. Patients who have a high caffeine intake (> 5 caffeinated beverages e.g., coffee, tea, cola per day).
19. Patients who have had a lower respiratory tract infection (LRTI) within 4 weeks prior to screening or Visit 1.
20. Patients who are night shift workers with night shifts within 8 weeks prior to screening or Visit 1 and during the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method