Trial intelligence / Profile preview

Efficacy and Safety of PT003, PT005, and PT001 in COPD (PINNACLE 2)

NCT01854658Phase 3

Key facts

Status: Completed
Start: Jul 2013
Primary completion: Mar 2015
Countries: 1
Sponsor: Pearl Therapeutics
Modality: Small Molecules

Drugs: BEVESPI AEROSPHERE
Conditions: chronic obstructive pulmonary disease (COPD)

Overview

Phase 3, randomised, double-blind trial of BEVESPI AEROSPHERE in chronic obstructive pulmonary disease (COPD) (4 arms), sponsored by Pearl Therapeutics. Primary endpoint: Change From Baseline in Morning Pre-dose Trough FEV1 at 24 weeks. Started Jul 2013; status: completed.

Design

4 arms

Study design: RandomizedDouble-blind

GFF MDI (PT003)
Glycopyrrolate/Formoterol Fumarate BID
GP MDI (PT001)
Glycopyrrolate BID
FF MDI (PT005)
Formoterol Fumarate BID
Placebo MDI
Placebo BID

Who it enrols

Patients 40-80 years old with moderate to very severe COPD, current or former smokers (>=10 pack-years), FEV1/FVC < 0.70 and FEV1 < 80% predicted. Excludes asthma, alpha-1 antitrypsin deficiency, unstable cardiac disease, and recent COPD exacerbations.

Endpoints

Primary

Change From Baseline in Morning Pre-dose Trough FEV124 weeks

Secondary

Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks24 weeks
Peak FEV124 weeks
St. George Respiratory Questionnaire Score24 weeks
Rescue Ventolin HFA Use24 weeks
Onset of Action as Assessed by FEV1Day 1

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