AsthmaPhase 2NCT05472662
A Study to Compare the Effects of Two Propellants in Adults With Mild Asthma
A Phase 2 study of Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.
Trial 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 adults with mild asthma. HFA=Hydrofluoroalkane Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Aug 2022to 31 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Diagnosis of asthma: documented established diagnosis of mild asthma for at least 6 months according to Step 1 of the Global Initiative for Asthma (GINA) 2021 guidelines.
- 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.
- Current asthma therapy: as needed low-dose inhaled corticosteroids (ICS)-formoterol, as needed short-acting β2-agonists (SABA), or low-dose ICS whenever SABA was 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.
- 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.
- 11. Male subjects fulfilling one of the following criteria:
- Fertile male subjects with pregnant or non-pregnant women of childbearing potential (WOCBP) partners: they must be willing to use male condom from the signature of the Informed Consent Form (ICF) and until the follow-up visit/call, or;
- Non-fertile male subjects (contraception is not required in this case), or;
- Fertile male subjects with women of non-childbearing potential (WONCBP) partner (contraception is not required in this case).
Who cannot join
- History of "at risk" asthma.
- Recent exacerbation.
- Asthma requiring use of biologics.
- Respiratory disorders other than asthma.
- Lung cancer or history of lung cancer.
- Lung resection.
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- Lower respiratory tract infection.
- Documented coronavirus disease 2019 (COVID-19) diagnosis.
- Smoking status: current smoker, or ex-smoker with a smoking history of ≥10 pack-years.
- 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.
- Cardiovascular diseases: subjects who have known and clinically significant (CS) cardiovascular conditions.
- 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.
- Central nervous system disorders: subjects with a history of symptoms or significant neurological disease.
- 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.
- Laboratory abnormalities: subjects with CS laboratory abnormalities indicating a significant or unstable concomitant disease.
- Alcohol/drug abuse.
- Participation to investigational trial: subjects who have received any investigational drug within the 30 days (60 days for biologics) prior to screening.
- 16. 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Randomised, Double-blind, Controlled, 2-way Cross-over Study to Assess the Potential for Bronchoconstriction of the New Propellant HFA-152a Versus the Marketed HFA-134a Propellant, in Adult Subjects With Mild Asthma
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 adults with mild asthma.
HFA=Hydrofluoroalkane
- Conditions
- Asthma
- Being tested
- Placebo 152a, Placebo 134a
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo 152aDrug
Placebo pressurised metered-dose inhaler (pMDI) formulated with the 152a propellant
Placebo 134aDrug
Placebo pressurised metered-dose inhaler (pMDI) formulated with the 134a propellant
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Placebo HFA-152a propellant via pressurised metered-dose inhaler (pMDI):
Administration: Single-dose administration. Receives: Drug: Placebo 152a |
| Reference | Placebo comparator | Placebo HFA-134a propellant via pressurised metered-dose inhaler (pMDI):
Administration: Single-dose administration. Receives: Drug: Placebo 134a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Relative Change From Baseline* in Forced Expiratory Volume in 1 s (FEV1) -- 15 Min Post-dose
Safety: Relative change from baseline* in forced expiratory volume in 1 s (FEV1) at the 15 min post-dose time point. Results are presented as adjusted mean and 95% confidence interval (CI.)
The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2).
T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points.
T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points.
*The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Measured: At 15 min post-dose after T1.
Secondary outcomes (13)
Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points
Safety: Relative change from baseline* in FEV1 at all the other post-dose time points (5 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1). Results are presented as adjusted mean and 95% CI.
The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2).
T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points.
T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points.
*The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Measured: At 5 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose
Safety: Absolute change from baseline* in FEV1 at all post-dose time points. Results are presented as adjusted mean and 95% CI.
The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2).
T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points.
T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points.
The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Measured: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points
Safety: Number and percentage of subjects with a relative change from baseline* in FEV1 at each post-dose time point <-15%.
The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Measured: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Change From Baseline* in FEV1 Area Under the Concentration-time Curve From Time Zero to 3 Hours (AUC0-3h)
Change from baseline* in FEV1 area under the concentration-time curve from time zero to 3 hours (AUC0-3h). Results show the change from baseline in FEV1 AUC(0-3h) corrected for Time, in litres
The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2).
T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points.
T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points.
*The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Measured: At 3 h post-dose.
Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points
Safety: Relative change from baseline* in peak expiratory flow (PEF) at all post-dose time points.
The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2).
T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points.
T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points.
The baseline PEF values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Measured: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points
Safety: Absolute change from baseline* in PEF at all post-dose time points. The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2).
T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points.
T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points.
The baseline PEF values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
Measured: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Subjects With Use of Rescue Medication -- 3 h Post Dose
Number and percentage of subjects with use of rescue medication in the 3 h post dose.
Measured: 3 h post-dose.
Safety and Tolerability: Vital Signs -- Diastolic Blood Pressure
Safety and tolerability: Mean change from baseline in the Vital Signs -- Diastolic Blood Pressure
Measured: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: Vital Signs -- Systolic Blood Pressure
Safety and tolerability: Mean change from baseline in the Vital Signs -- Systolic Blood Pressure
Measured: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- Heart Rate
Safety and tolerability: Mean change from baseline in the ECG parameter -- Heart rate
Measured: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- PR Interval
Safety and tolerability: Mean change from baseline in the ECG parameter -- PR interval.
Measured: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- QRS
Safety and tolerability: Mean change from baseline in the ECG parameter -- QRS interval.
Measured: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- QTcF Interval
Safety and tolerability: Mean change from baseline in the ECG parameter -- QTcF interval.
Measured: At 45 min, 1.75 h, 2.75 h post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start3 Aug 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, MD, Principal investigator, Medicines Evaluation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472662
- Sponsor's protocol ID
- CLI-05993AB6-07
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2022
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Randomised, Double-blind, Controlled, 2-way Cross-over Study to Assess the Potential for Bronchoconstriction of the New Propellant HFA-152a Versus the Marketed HFA-134a Propellant, in Adult Subjects With Mild Asthma
- ClinicalTrials.gov ID
- NCT05472662
- Acronym / sponsor ID
- CLI-05993AB6-07
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 3 Aug 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 adults with mild asthma.
HFA=Hydrofluoroalkane
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Placebo 152aPlacebo HFA-152a propellant via pressurised metered-dose inhaler (pMDI): Administration: Single-dose administration. |
| Reference | Placebo comparator | Drug: Placebo 134aPlacebo HFA-134a propellant via pressurised metered-dose inhaler (pMDI): Administration: Single-dose administration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
- Diagnosis of asthma: documented established diagnosis of mild asthma for at least 6 months according to Step 1 of the Global Initiative for Asthma (GINA) 2021 guidelines.
- 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.
Key exclusion criteria (20 listed)
- 16. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo 152aPlacebo pressurised metered-dose inhaler (pMDI) formulated with the 152a propellant | Drug | Test |
| Placebo 134aPlacebo pressurised metered-dose inhaler (pMDI) formulated with the 134a propellant | Drug | Reference |
Primary outcome
Safety: Relative Change From Baseline* in Forced Expiratory Volume in 1 s (FEV1) -- 15 Min Post-dose
Time frame: At 15 min post-dose after T1.
Safety: Relative change from baseline* in forced expiratory volume in 1 s (FEV1) at the 15 min post-dose time point. Results are presented as adjusted mean and 95% confidence interval (CI.) The potential of the test propellant (HFA-152a vs HFA-134a) for bronchoconstriction was evaluated using centralised spirometry assessments performed during treatment period 1 (TP1) and treatment period 2 (TP2). T0 was defined as the moment when the first inhalation took place, and was used to calculate the pre-dose time points. T1 was defined as the moment when the last inhalation took place, and was used to calculate the post-dose time points. *The baseline FEV1 values were the mean of the two pre-dose assessments (i.e., performed at 45 min and 15 min before T0).
13 secondary outcomes
Safety: Safety: Relative Change From Baseline* in FEV1 -- All Other Post-dose Time Points
Time frame: At 5 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Absolute Change From Baseline* in FEV1 -- All Time Points Post Dose
Time frame: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Subjects With a Relative Change From Baseline* in FEV1 <-15% -- All Post-dose Time Points
Time frame: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Change From Baseline* in FEV1 Area Under the Concentration-time Curve From Time Zero to 3 Hours (AUC0-3h)
Time frame: At 3 h post-dose.
Safety: Relative Change From Baseline* in Peak Expiratory Flow (PEF) -- All Post-dose Time Points
Time frame: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Absolute Change From Baseline* in PEF -- All Post-dose Time Points
Time frame: At 5 min, 15 min, 30 min, 1 h, 1 h 30 min, and 3 h after T1.
Safety: Subjects With Use of Rescue Medication -- 3 h Post Dose
Time frame: 3 h post-dose.
Safety and Tolerability: Vital Signs -- Diastolic Blood Pressure
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: Vital Signs -- Systolic Blood Pressure
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- Heart Rate
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- PR Interval
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- QRS
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Safety and Tolerability: ECG Parameter -- QTcF Interval
Time frame: At 45 min, 1.75 h, 2.75 h post dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Singh, MD principal investigator
Medicines Evaluation Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of 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 13 inclusion and 20 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 15 Oct 2024. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety: Relative Change From Baseline* in Forced Expiratory Volume in 1 s (FEV1) -- 15 Min Post-dose (time frame: At 15 min post-dose after T1.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.