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

NCT05875025 | Completed Phase 1 Results

• 1 other identifier: CLI-05993AB6-06
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Mucociliary Clearance

Outcome Measures

Primary Outcomes (2)

• 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

  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

  4 hours post inhalation of radiolabelled particles

Other Outcomes (1)

• Mucociliary Clearance -- AUC(0-4) -- Right Whole Lung Region

  Post inhalation of radiolabelled particles; baseline and 4 h after inhalation of the radiotracer on Day 8.

Study Arms (2)

Test Propellant

EXPERIMENTAL

Placebo HFA-152a propellant

Other: Placebo formulated with HFA-152a propellant via pMDI

Reference Propellant

PLACEBO COMPARATOR

Placebo HFA-134a propellant

Other: Placebo formulated with HFA-134a propellant via pMDI

Interventions

Placebo formulated with HFA-152a propellant via pMDI OTHER

5 inhalations BID (morning and evening) for 8 consecutive days, starting from the morning of Day 1 until the morning of Day 8

Test Propellant

Placebo formulated with HFA-134a propellant via pMDI OTHER

5 inhalations BID (morning and evening) for 8 consecutive days, starting from the morning of Day 1 until the morning of Day 8

Reference Propellant

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Vital signs within normal limits at screening; body temperature \< 37.5°C;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

BDD Pharma - Bio-Imaging Centre

Glasgow, G4 0SF, United Kingdom

Location

Results Point of Contact

• Title: Clinical Trial Transparency
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+ 39 0521 2791

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: June 26, 2023
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)