A Study to Compare the Effects of Two Propellants in Adults With Mild Asthma
Study Details
Study Description
Brief Summary
This is a Phase IIa, multicentre, single dose, randomised, double blind, controlled, 2 way cross over study to evaluate the potential for bronchoconstriction of the new HFA-152a propellant (single dose) versus the marketed HFA-134a propellant (single dose) in adult subjects with mild asthma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Test Treatment Placebo HFA-152a propellant via pMDI: Administration: Single-dose administration. |
Drug: Placebo 152a
Placebo pMDI formulated with the 152a propellant
|
| Placebo Comparator: Reference treatment Placebo HFA-134a propellant via pMDI: Administration: Single-dose administration. |
Drug: Placebo 134a
Placebo pMDI formulated with the 134a propellant
|
Outcome Measures
Primary Outcome Measures
- Safety variable evaluating the potential for bronchoconstriction [at the 15 minutes post-dose timepoint]
Relative change from baseline in FEV1
Secondary Outcome Measures
- Safety variables completing the evaluation of the potential for bronchoconstriction [from 5 minutes to 3 hours post-dose timepoints]
Changes from baseline in FEV1
- Safety variables completing the evaluation of the potential for bronchoconstriction [From 5 minutes to 3 hours post-dose timepoints]
Number and percentage of subjects with a relative change from baseline in FEV1 <-15%;
- Safety variables completing the evaluation of the potential for bronchoconstriction [3 hours post-dose]
Change from baseline in FEV1 area under the concentration-time curve from time zero to 3 hours (AUC0-3h);
- Safety variables completing the evaluation of the potential for bronchoconstriction [From 5 minutes to 3 hours post-dose timepoints]
Changes from baseline in PEF at all post-dose timepoints;
- Safety variables completing the evaluation of the potential for bronchoconstriction [3 hours post-dose]
Number and percentage of subjects with use of rescue medication in the 3 h post dose
- Safety variables completing the evaluation of the potential for bronchoconstriction [3 hours post-dose]
Mean use (puffs) of rescue medication in the 3 h post dose
- Safety and tolerability of the product [Through study completion, an average of 1 year]
Number of subjects experiencing treatment emergent adverse events and adverse drug reactions
- Safety and tolerability of the product [3 hours post dose]
The mean absolute values and mean changes from baseline in each ECG (Electrocardiogram) parameter (Heart Rate and other parameters)
- Safety and tolerability of the product [3 hours post dose]
Vital signs (Sistolic Blood Pressure and Diastolic Blood Pressure) values at pre-dose and post-dose timepoint and change from baseline
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject's written informed consent obtained prior to any study related procedure;
-
Gender and age: Male or female adults aged from 18 to 75 years old (inclusive);
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Diagnosis of asthma: documented established diagnosis of mild asthma for at least 6 months according to Step 1 of the GINA 2021 guidelines;
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Lung function: subjects with a pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≥60% of the predicted normal value and
≥1.5 L at screening and prior to randomisation, after appropriate wash-out from bronchodilators;
-
Documented excessive variability in lung function
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Current asthma therapy: as needed low-dose inhaled corticosteroids (ICS)-formoterol, as needed short-acting β2-agonists (SABA), or low-dose ICS whenever SABA is taken; taken not more than twice a week (2 events) in the 4 weeks prior to screening or in the 6 weeks prior to randomisation
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Asthma control: controlled or partly controlled based on an Asthma Control Questionnaire© (ACQ-5) score <1.5 at screening and prior to randomisation;
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Ability to use the inhalers
-
Ability to comply with the protocol:
10: Female subjects of non-childbearing potential (defined as physiologically incapable of becoming pregnant (i.e. postmenopausal or permanently sterile) and Female subjects of childbearing potential, who accepts the use of highly effective contraceptive methods during the study or with non-fertile male partners.
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Male subjects fulfilling one of the following criteria:
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Fertile male subjects with pregnant or non-pregnant WOCBP partners: they must be willing to use male condom from the signature of the ICF and until the follow-up visit/call, or;
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Non-fertile male subjects (contraception is not required in this case), or;
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Fertile male subjects with WONCBP partner (contraception is not required in this case).
Exclusion criteria:
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History of "at risk" asthma;
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Recent exacerbation;
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Asthma requiring use of biologics;
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Respiratory disorders other than asthma;
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Lung cancer or history of lung cancer;
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Lung resection
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Lower respiratory tract infection;
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Documented coronavirus disease 2019 (COVID-19) diagnosis
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Smoking status: current smoker, or ex-smoker with a smoking history of ≥10 pack-years
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Cancer or history of cancer (other than lung cancer);subject with active cancer or a history of cancer with less than 5 years disease-free survival time
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Cardiovascular diseases:subjects who have known and clinically significant (CS) cardiovascular conditions
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Electrocardiogram (ECG) criteria: any CS abnormal 12-lead ECG that, in the Investigator's opinion, would affect safety evaluations or place the subject at risk
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Central nervous system disorders: subjects with a history of symptoms or significant neurological disease
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Other concurrent diseases: subjects with historical or current evidence of uncontrolled concurrent disease such as, but not limited to, hyperthyroidism, diabetes mellitus or other endocrine disease, haematological disease, autoimmune disorders (e.g. rheumatoid arthritis), gastrointestinal disorders (e.g. poorly controlled peptic ulcer, gastroesophageal reflux disease), significant renal impairment or other disease or condition that might, in the judgement of the Investigator, place the subject at undue risk or potentially compromise the results or interpretations of the study
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Laboratory abnormalities: subjects with CS laboratory abnormalities indicating a significant or unstable concomitant disease
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Alcohol/drug abuse
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Participation to investigational trial: subjects who have received any investigational drug within the 30 days (60 days for biologics) prior to screening
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Hypersensitivity: history of hypersensitivity to any of the study medications components 17.Subjects mentally or legally incapacitated 18. Recent eye surgery or any condition where raised intracranial pressure (caused by forceful exhalation) would be harmful; 19. For female subjects only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medicine Evaluation Unit Limited | Manchester | United Kingdom |
Sponsors and Collaborators
- Chiesi Farmaceutici S.p.A.
Investigators
- Principal Investigator: Dave Singh, MD, Medicines Evaluation Unit
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLI-05993AB6-07