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

NCT ID: NCT06506266

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-29
• Study Completion Date: 2024-10-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HFA-152a followed by HFA-134a

Group Type: EXPERIMENTAL

HFA-152a

Intervention Type: OTHER

HFA-152a is administered via oral inhalation

HFA-134a

Intervention Type: OTHER

HFA-134a is administered via oral inhalation

Radiolabeled saline solution

Intervention Type: OTHER

Radiolabeled saline solution is administered via oral inhalation

HFA-134a followed by HFA-152a

Group Type: EXPERIMENTAL

HFA-152a

Intervention Type: OTHER

HFA-152a is administered via oral inhalation

HFA-134a

Intervention Type: OTHER

HFA-134a is administered via oral inhalation

Radiolabeled saline solution

Intervention Type: OTHER

Radiolabeled saline solution is administered via oral inhalation

Interventions

HFA-152a

HFA-152a is administered via oral inhalation

Intervention Type: OTHER

HFA-134a

HFA-134a is administered via oral inhalation

Intervention Type: OTHER

Radiolabeled saline solution

Radiolabeled saline solution is administered via oral inhalation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.
• Capable of giving written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Capable of using inhaler device with no physical or other issues which would impair the participant's ability to successfully use a metered dose inhaler (MDI) inhaler as instructed in this study.
• Ability to comply with the protocol. Participants have capacity and no issues which would impair their ability to comply with all aspects of the protocol during the study

Exclusion Criteria

• 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

221781

Identifier Type: -

Identifier Source: org_study_id