A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)

ConditionAsthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

About this trial

This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant must be aged greater than equal to (>=)18 years at the time of signing the informed consent.

Documented history of asthma, as defined by Global Initiative for Asthma (GINA)

Short-Acting beta2-Adrenoreceptor Agonists (SABA) as needed (prn) only

Inhaled corticosteroid (ICS)/SABA prn only

Disqualifiers

Participants with a history of life-threatening asthma.

Participants with other significant pulmonary diseases, including (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other significant respiratory abnormalities other than asthma.

Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening.

Participants with severe asthma exacerbation: Defined as any asthma exacerbation requiring >=3 days systemic corticosteroids or that resulted in overnight hospitalization or Emergency Department visit requiring additional treatment for asthma within the 3 months prior to screening.

Trial design

Design model

Crossover

Treatments tested in this trial

  • HFA-152a

    Drug

    HFA-152a will be administered.

  • HFA-134a

    Drug

    HFA-134a will be administered.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Participants receiving HFA-152a followed by HFA-134aExperimental treatment 2 interventions
Group B: Participants receiving HFA-134a followed by HFA-152aExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to 8 weeks

Secondary outcomes

1

Number of participants with serious adverse events (SAEs)

Time frame
Up to 8 weeks
2

Absolute values for vital sign parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Millimeters of mercury [mmHg])

Time frame
At Days 1 and 15
3

Absolute values for vital sign parameter: Pulse rate

Time frame
At Days 1 and 15
4

Change from Baseline in vital sign parameters: SBP and DBP (mmHg)

Time frame
Baseline and Day 15

Other outcomes

Sponsors and contacts

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