A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

Pearl Therapeutics

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disorder

Treatments: Drug: FF MDI (PT005) 9.6 μg; Drug: BFF MDI (PT009) 320/9.6 μg; Drug: BFF MDI (PT009) 160/9.6 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02727660

PT009003

Details and patient eligibility

About

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

Full description

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.

Enrollment: 1,876 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Give their signed written informed consent to participate
2. At least 40 years of age and no older than 80 years of age
3. COPD patients who are symptomatic
4. Must be receiving one or more inhaled bronchodilators as maintenance therapy
5. Must have a documented history of COPD exacerbations

Exclusion criteria

1. Current diagnosis of asthma
2. COPD due to α1-Antitrypsin Deficiency
3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
4. Long-term-oxygen therapy (≥ 15 hours a day).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,876 participants in 3 patient groups

BFF MDI (PT009) 320/9.6 μg

Experimental group

Description:

Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Treatment:

Drug: BFF MDI (PT009) 320/9.6 μg

BFF MDI (PT009) 160/9.6 μg

Experimental group

Description:

Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Treatment:

Drug: BFF MDI (PT009) 160/9.6 μg

FF MDI (PT005) 9.6 μg

Experimental group

Description:

Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID

Treatment:

Drug: FF MDI (PT005) 9.6 μg