BFF MDI 160/9.6 μg

DRUG3 trials

Sponsors

Pearl Therapeutics, Inc., AstraZeneca

Conditions

AsthmaChronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary Disorder

Phase 2

Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

CompletedNCT02196077

Pearl Therapeutics, Inc.Chronic Obstructive Pulmonary Disease

Start: 2014-08-01End: 2015-03-01Updated: 2018-06-20

Phase 3

Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD

CompletedNCT02766608

Pearl Therapeutics, Inc.Chronic Obstructive Pulmonary Disorder

Start: 2016-05-31End: 2017-12-01Updated: 2019-09-24

A 24-Week Efficacy and Safety Study to Assess Budesonide and Formoterol Fumarate Metered Dose Inhaler in Adult and Adolescent Participants With Inadequately Controlled Asthma (VATHOS)

CompletedNCT05202262

AstraZenecaAsthma

Start: 2022-01-12End: 2025-02-26Updated: 2026-01-28

Related Papers

Budesonide/formoterol fumarate dihydrate vs budesonide with a novel suspension technology for uncontrolled asthma: Phase 3 VATHOS study

ERJ Open Research2026-08-06

Predictive modeling of COPD exacerbation rates using baseline risk factors

Therapeutic Advances in Respiratory Disease2022-01-0124 citations

Efficacy and safety of two doses of budesonide/formoterol fumarate metered dose inhaler in COPD

ERJ Open Research2020-04-018 citations

Pneumonia risk with budesonide-containing therapies in COPD: pooled analysis of three Phase III studies

2019-09-28

Efficacy and safety of budesonide/formoterol fumarate dihydrate metered dose inhaler (BFF MDI) using co-suspension delivery technology compared to monocomponents and an active comparator in COPD

2018-09-15

Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study

European Respiratory Journal2018-09-0121 citations

Efficacy, safety, and pharmacokinetics of budesonide/formoterol fumarate delivered via metered dose inhaler using innovative co-suspension delivery technology in patients with moderate-to-severe COPD.

2018-05-082 citations

Benefit of FDC budesonide (BUD) and formoterol fumarate (FF) FDC delivered by a novel MDI co-suspension technology (BFF MDI), in patients (pts) with moderate-to-severe COPD

2016-09-01