Mucociliary ClearancePhase 1NCT05875025

Study to Assess the Effect of the New HFA-152a Propellant on Mucociliary Clearance

A Phase 1 study of Mucociliary Clearance, run by Chiesi Farmaceutici S.p.A. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study was to assess the effect of multiple doses of the HFA-152a propellant and the HFA-134a propellant on mucociliary clearance (MCC). Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Mucociliary Clearance
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 1 siteUnited Kingdom
Study dates: 26 Jun 2023to 8 Sep 2023
Phase: Phase 1
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject's written informed consent obtained prior to any study-related procedure;
Healthy male and female subjects aged 18-55 years (inclusive);
Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly;
Body Mass Index (BMI) between 18 and 30 kg/m2 (extremes inclusive);
Non-smokers or ex-smokers who smoked < 5 pack-years and stopped smoking > 5 years prior to screening;
Good physical and mental status at screening and before randomisation;

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Vital signs within normal limits at screening; body temperature < 37.5°C;
12-lead digitised electrocardiogram (ECG) in triplicate considered as normal at screening;
Lung function measurements within normal limits at screening;
Female subjects fulfilling one of the following criteria: Women of non-childbearing potential (WONCBP). Women of childbearing potential (WOCBP) with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method preferably with low user dependency, from the signature of the informed consent form (ICF) and until the follow-up call.
Male subjects fulfilling one of the following criteria: Fertile male subjects with a pregnant or non-pregnant WOCBP partner: they must be willing to use male condom, from the signature of the ICF until the follow-up call.

Who cannot join

Participation in another clinical study with an investigational drug in the 3 months or five half-lives of that investigational drug (whichever is longer) preceding the administration of the study treatment;
Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders ;
Clinically relevant abnormal laboratory values at screening;
Subjects with history of breathing problems (i.e. history of asthma including childhood asthma);
Positive serology test for human immunodeficiency virus (HIV) 1 or HIV2 serology at screening;
Positive results from the hepatitis serology, indicating acute or chronic hepatitis B or hepatitis C at screening;

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Blood donation or blood loss (≥ 450 mL) during the 2 months prior to screening or randomisation;
Positive urine test for cotinine at screening or prior to randomisation;
Documented history of alcohol abuse within 12 months prior to screening, an average weekly alcohol intake of greater than 14 units, or a positive alcohol breath test at screening or prior to randomisation;
Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen evaluated at screening or prior to randomisation;
Intake of non-permitted concomitant medications in the predefined period prior to screening or prior to randomisation;
Presence of any current infection, or previous infection that resolved less than 1 week prior to screening or to randomisation;
Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the study;
Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 2 weeks, or associated complications/symptoms which have not resolved within 2 weeks prior to screening or prior to randomisation;
Heavy caffeine drinker;
For females only: pregnant or lactating women;
The use of any kind of smoking electronic devices (e.g. e-cigarettes), within 6 months before screening or prior to randomisation;
Subjects for whom participation in this study will exceed a total radiation exposure of 5 mSv in the last 12-month period or 10 mSv in the last 5-year period;
Subjects with a total dosimetry value (including history of exposure through occupation) which contraindicates their participation in the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

BDD Pharma - Bio-Imaging Centre
Glasgow, G4 0SF

Other trials in United Kingdom

About this study

Official title: Open-label, Randomised, Controlled, 2-way Cross-over Study to Assess the Effect of Multiple Doses of the New HFA-152a Propellant Versus the Marketed HFA-134a Propellant on Mucociliary Clearance in Healthy Volunteers

The primary objective of this study was to assess the effect of multiple doses of the HFA-152a propellant and the HFA-134a propellant on mucociliary clearance (MCC).

Read the detailed description

This clinical trial was a Phase I, single-centre, multiple-dose, randomised, open-label, controlled, 2-way cross-over study to assess the effect on MCC of the new HFA-152a propellant (5 inhalations BID for 8 days) versus the marketed HFA-134a propellant (5 inhalations BID for 8 days) in adult healthy volunteers by measuring the clearance from the lungs of inhaled radioaerosol.

A total of 20 subjects were randomised into the study.

Standard safety assessments was conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs, spirometry, and observations of any adverse events (AE).

Conditions: Mucociliary Clearance
Being tested: Placebo formulated with HFA-152a propellant via pMDI, Placebo formulated with HFA-134a propellant via pMDI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo formulated with HFA-152a propellant via pMDIOther
5 inhalations BID (morning and evening) for 8 consecutive days, starting from the morning of Day 1 until the morning of Day 8
Placebo formulated with HFA-134a propellant via pMDIOther
5 inhalations BID (morning and evening) for 8 consecutive days, starting from the morning of Day 1 until the morning of Day 8

Study groups in NCT05875025
Study group	Role	What they receive
Test Propellant	Experimental	Placebo HFA-152a propellant Receives: Other: Placebo formulated with HFA-152a propellant via pMDI
Reference Propellant	Placebo comparator	Placebo HFA-134a propellant Receives: Other: Placebo formulated with HFA-134a propellant via pMDI

What is being measured

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

Mucociliary Clearance Rate -- Right Whole Lung -- Percent Particle Retention at 2 Hours (PPR2) on Day 8
MCC rate was assessed by the percent particle retention at 2 hours (PPR2) after the inhalation of radiolabelled particles.
Results are shown as adjusted mean (95% CI) for change from baseline in PPR2 (right whole lung) on Day 8, considering either HFA-152a and HFA-134a propellants.
PPR2=Percent particle retention at 2 h after the inhalation of radiolabelled particles
Measured: 2 hours post inhalation of radiolabelled particles
Mucociliary Clearance Rate -- Right Whole Lung -- Percent Particle Retention at 4 Hours (PPR4) on Day 8
Mucociliary Clearance rate (MCC) rate, as assessed by the percent particle retention (PPR) (in right whole lung) at 4 h after the inhalation of radiolabelled particles (PPR4), on Day 8.
Results are shown as adjusted mean (95% CI) for change from baseline in PPR4 (right whole lung) on Day 8, considering either HFA-152a and HFA-134a propellants.
PPR4=Percent particle retention at 4 h after the inhalation of radiolabelled particles
Measured: 4 hours post inhalation of radiolabelled particles

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 20238 Sep 2023

First posted25 May 2023
Study start26 Jun 2023
Primary completion8 Sep 2023
Study completion8 Sep 2023

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 Mucociliary ClearanceStudies 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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05875025
Sponsor's protocol ID: CLI-05993AB6-06
Status last verified: Sep 2024
First submitted: 16 May 2023
Last updated: 12 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Asthma
Not yet recruiting
Effect of Continuous Nebulisation of Isotonic Saline Solution Combined With Heated Humidification on Mucociliary Clearance in Healthy Subjects
Healthy Subjects (HS)
Not yet recruiting
Clearance in Primary Ciliary Dyskinesia
Primary Ciliary Dyskinesia, PCD
RecruitingObservational study
Pathogenesis of Primary Ciliary Dyskinesia (PCD) Lung Disease
Kartagener Syndrome
Enrolling by invitation
Clean Air for Rare MUcociliary Clearance dIsorders
Primary Ciliary Dyskinesia (PCD), Cystic Fibrosis (CF)

All Mucociliary Clearance trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Randomised, Controlled, 2-way Cross-over Study to Assess the Effect of Multiple Doses of the New HFA-152a Propellant Versus the Marketed HFA-134a Propellant on Mucociliary Clearance in Healthy Volunteers
ClinicalTrials.gov ID: NCT05875025
Acronym / sponsor ID: CLI-05993AB6-06
Conditions: Mucociliary Clearance
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
Study start: 26 Jun 2023 (actual)
Primary completion: 8 Sep 2023 (actual)
Study completion: 8 Sep 2023 (actual)
First posted: 25 May 2023 (actual)
Results: Posted 12 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study was to assess the effect of multiple doses of the HFA-152a propellant and the HFA-134a propellant on mucociliary clearance (MCC).

Detailed description

A total of 20 subjects were randomised into the study.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test Propellant	Experimental	Other: Placebo formulated with HFA-152a propellant via pMDIPlacebo HFA-152a propellant
Reference Propellant	Placebo comparator	Other: Placebo formulated with HFA-134a propellant via pMDIPlacebo HFA-134a propellant

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Subject's written informed consent obtained prior to any study-related procedure;
Healthy male and female subjects aged 18-55 years (inclusive);
Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly;
Body Mass Index (BMI) between 18 and 30 kg/m2 (extremes inclusive);
Non-smokers or ex-smokers who smoked < 5 pack-years and stopped smoking > 5 years prior to screening;

Key exclusion criteria (19 listed)

Participation in another clinical study with an investigational drug in the 3 months or five half-lives of that investigational drug (whichever is longer) preceding the administration of the study treatment;
Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders ;
Clinically relevant abnormal laboratory values at screening;
Subjects with history of breathing problems (i.e. history of asthma including childhood asthma);
Positive serology test for human immunodeficiency virus (HIV) 1 or HIV2 serology at screening;

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 formulated with HFA-152a propellant via pMDI5 inhalations BID (morning and evening) for 8 consecutive days, starting from the morning of Day 1 until the morning of Day 8	Other	Test Propellant
Placebo formulated with HFA-134a propellant via pMDI5 inhalations BID (morning and evening) for 8 consecutive days, starting from the morning of Day 1 until the morning of Day 8	Other	Reference Propellant

Primary outcome

Mucociliary Clearance Rate -- Right Whole Lung -- Percent Particle Retention at 2 Hours (PPR2) on Day 8
Time frame: 2 hours post inhalation of radiolabelled particles
MCC rate was assessed by the percent particle retention at 2 hours (PPR2) after the inhalation of radiolabelled particles. Results are shown as adjusted mean (95% CI) for change from baseline in PPR2 (right whole lung) on Day 8, considering either HFA-152a and HFA-134a propellants. PPR2=Percent particle retention at 2 h after the inhalation of radiolabelled particles
Mucociliary Clearance Rate -- Right Whole Lung -- Percent Particle Retention at 4 Hours (PPR4) on Day 8
Time frame: 4 hours post inhalation of radiolabelled particles
Mucociliary Clearance rate (MCC) rate, as assessed by the percent particle retention (PPR) (in right whole lung) at 4 h after the inhalation of radiolabelled particles (PPR4), on Day 8. Results are shown as adjusted mean (95% CI) for change from baseline in PPR4 (right whole lung) on Day 8, considering either HFA-152a and HFA-134a propellants. PPR4=Percent particle retention at 4 h after the inhalation of radiolabelled particles

Results and safety

Results posted to the registry on 12 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HFA-152a Followed by HFA-134a	10	10
HFA-134a Followed by HFA-152a	10	10

Primary outcome: Mucociliary Clearance Rate -- Right Whole Lung -- Percent Particle Retention at 2 Hours (PPR2) on Day 8

Time frame: 2 hours post inhalation of radiolabelled particles. Mean (95% Confidence Interval). Unit: percent of particle retention

Measure	Test Propellant n = 20	Reference Propellant n = 20
Value	0.94 (-1.47 to 3.34)	-0.42 (-2.82 to 1.98)

Test Propellant vs Reference Propellant: Adjusted mean difference: 1.36 (95% CI -2.28 to 4.99), p = 0.442, ANCOVA

Population analysed: The ITT analysis set, defined as all subjects who were randomised and received at least one dose of study treatment (analysed as randomised), included 20 subjects.

Primary outcome: Mucociliary Clearance Rate -- Right Whole Lung -- Percent Particle Retention at 4 Hours (PPR4) on Day 8

Time frame: 4 hours post inhalation of radiolabelled particles. Least squares mean (95% Confidence Interval). Unit: percent of particle retention

Measure	Test Propellant n = 20	Reference Propellant n = 20
Value	-0.58 (-2.29 to 1.14)	-1.27 (-2.99 to 0.44)

Test Propellant vs Reference Propellant: Adjusted mean difference: 0.70 (95% CI -1.73 to 3.12), p = 0.553, ANCOVA

Population analysed: The ITT analysis set, defined as all subjects who were randomised and received at least one dose of study treatment (analysed as randomised), included 20 subjects.

Adverse events

Time frame: The recording of adverse events (AEs) was the period starting from the time of the Informed Consent signature (Visit 1, Day 2 to 21 before Treatment period 1 (Day-1)) and until the subject's study participation ended at either an Early termination visit or a Follow-up visit or call ( 7-10 days after last intake of study treatment).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Propellant	0 of 20 (0%)	5 of 20 (25%)	0 of 20
Reference Propellant	0 of 20 (0%)	7 of 20 (35%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Mucociliary Clearance

RecruitingPhase 4
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Asthma
Not yet recruiting
Effect of Continuous Nebulisation of Isotonic Saline Solution Combined With Heated Humidification on Mucociliary Clearance in Healthy Subjects
Healthy Subjects (HS)
Not yet recruiting
Clearance in Primary Ciliary Dyskinesia
Primary Ciliary Dyskinesia, PCD
RecruitingObservational study
Pathogenesis of Primary Ciliary Dyskinesia (PCD) Lung Disease
Kartagener Syndrome
Enrolling by invitation
Clean Air for Rare MUcociliary Clearance dIsorders
Primary Ciliary Dyskinesia (PCD), Cystic Fibrosis (CF)

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Mucociliary Clearance, 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 11 inclusion and 19 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 12 Nov 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 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?

Yes. Results are posted in the registry (first posted 12 Nov 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?

Mucociliary Clearance Rate -- Right Whole Lung -- Percent Particle Retention at 2 Hours (PPR2) on Day 8 (time frame: 2 hours post inhalation of radiolabelled particles). The study lists 2 primary outcomes in all. 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 NCT05875025.

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 12 Nov 2024.