Study of the Effect of HFA-152a and HFA-134a Propellants on Mucociliary Clearance in Healthy Participants

NCT06506266 | Completed Phase 1 Results

• 1 other identifier: 221781
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of the study is to assess the effect of the administration of reference propellant \[HFA-134a (1,1,1,2 - Tetrafluoroethane)\] and test propellant \[HFA-152a (1 - Difluoroethane)\] in healthy adults on mucociliary clearance (MCC).

Conditions

Asthma

Keywords

HFA-152a; HFA-134a; Crossover; MCC

Outcome Measures

Primary Outcomes (1)

• Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7

  \[AUC(0-4h)\] was assessed for Mucociliary clearance (MCC) in participants following administration of nebulized 99mTc on Day 7. Gamma scintigraphy was utilized to conduct assessments.

  At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes on Day 7

Secondary Outcomes (4)

• Percentage of Radiolabeled Particle Retention at 1 Hour After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7

  1 hour after inhalation on Day 7

• Percentage of Radiolabeled Particle Retention at 1.5 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7

  1.5 hours after inhalation on Day 7

• Percentage of Radiolabeled Particle Retention at 3 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7

  3 hours after inhalation on Day 7

• Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

  Up to approximately 13 weeks

Study Arms (2)

HFA-152a followed by HFA-134a

EXPERIMENTAL

Other: HFA-152a; Other: HFA-134a; Other: Radiolabeled saline solution

HFA-134a followed by HFA-152a

EXPERIMENTAL

Other: HFA-152a; Other: HFA-134a; Other: Radiolabeled saline solution

Interventions

HFA-152a OTHER

HFA-152a is administered via oral inhalation

HFA-134a followed by HFA-152a; HFA-152a followed by HFA-134a

HFA-134a OTHER

HFA-134a is administered via oral inhalation

HFA-134a followed by HFA-152a; HFA-152a followed by HFA-134a

Radiolabeled saline solution OTHER

Radiolabeled saline solution is administered via oral inhalation

HFA-134a followed by HFA-152a; HFA-152a followed by HFA-134a

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants are eligible to be included in the study only if all following criteria apply:
• Male or Female, age 30 to 55 years
• Body Mass Index (BMI): 18.0 to 32.0 kg/m2, inclusive, at screening
• Weight: ≥50 kg
• Nonsmokers or ex-smokers for more than 6 months with a smoking history of \<10 pack years
• Status: healthy participants
• Spirometry data.
• Forced Expiratory Volume in 1 second (FEV1) ≥80% of predicted values.
• FEV1: Forced vital capacity (FVC) ratio \>70%.
• Females must be of nonchildbearing potential, and agree not to donate eggs (ova, oocytes) for the purpose of reproduction during the study intervention period and at least 30 days after the last dose of study intervention.
• Male participants are eligible to participate if they agree to:
• Refrain from donating sperm
• Either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
• Or must agree to use a male condom when having sexual intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. The female partner should additionally use a highly effective contraceptive method with a failure rate of \<1% per year.
• All prescribed medication must have been stopped at least 30 days prior to admission to the clinical research centre based on investigator judgment. An exception is made for Hormonal Replacement Therapy (HRT), and occasional paracetamol which may be used throughout the study.

You may not qualify if:

• Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker shall participate in the study.
• History or presence of any form of asthma, including childhood asthma and exercise induced asthma.
• Respiratory disorders other than asthma. A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, Chronic obstructive pulmonary disease (COPD), tuberculosis, known alpha 1 antitrypsin deficiency and other respiratory abnormalities other than asthma that, in the opinion of the investigator, could put the participant at risk through study participation or could affect the study analyses and data interpretation.
• Recent history of mild conditions potentially affecting Mucociliary clearance (MCC) (viral infections, cough, cold, active hay fever etc.) in the last 14 days.
• Recent use of drugs for treating conditions potentially affecting MCC (viral infections, cough, cold, etc.) in the last 30 days.
• Vaccine(s) within 2 weeks prior to admission or plans to receive such vaccines during the study.
• Current enrolment or past participation in this clinical study.
• Positive human immunodeficiency virus (HIV) antibody test.
• Regular use of known drugs of abuse, including Tetrahydrocannabinol (THC).
• Average intake of more than 21 units of alcohol per week in males and 14 units per week in females (clinical site standard: unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits) based on breath alcohol test.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

norflurane

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: July 29, 2024
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

GB (1)