Pittsburgh, PA

Allergy and Clinical Immunology

Asthma

Atopic Dermatitis

Alopecia Areata

Psoriasis

Vitiligo

Chronic Urticaria

Hidradenitis Suppurativa

Albuterol Sulfate

Fluticasone Propionate

Pfizer

Target PharmaSolutions

Teva Branded Pharmaceutical Products R&D LLC

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

The primary objective of the study is to assess the efficacy of high dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs).

Secondary Objectives:

To evaluate the efficacy of Fp/ABS low dose compared to ABS and the effect on systemic corticosteroid (SCS) exposure

To evaluate the safety and tolerability of Fp/A BS

The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 42 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria

A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

Allergy and Clinical Immunology | Pittsburgh, PA

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A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

Trial sponsors