Asthma
Conditions
Keywords
HFA-152a, HFA-134a, Crossover, MCC
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).
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
Healthy volunteers
Yes
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
Participants who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Percent Radiolabeled Particle Retention-time Curve up to 4 Hours [AUC(0-4h)] After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 | At 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, and 240 minutes 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Radiolabeled Particle Retention at 1 Hour After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 | 1 hour after inhalation on Day 7 | Gamma scintigraphy was utilized to conduct assessments. |
| 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 | Gamma scintigraphy was utilized to conduct assessments. |
| Percentage of Radiolabeled Particle Retention at 3 Hours After Nebulized 99mTechnetium (99mTc) Inhalation on Day 7 | 3 hours after inhalation on Day 7 | Gamma scintigraphy was utilized to conduct assessments. |
| Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Up to approximately 13 weeks | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect, abnormal pregnancy outcomes. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. The AE data presented below is of frequency threshold - 0%. |
Countries
United Kingdom
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.3 YEARS STANDARD_DEVIATION 7.09 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 22 |
| other Total, other adverse events | 2 / 24 | 4 / 22 |
| serious Total, serious adverse events | 0 / 24 | 0 / 22 |
Outcome results
None listed