PT003 MDI Dose Confirmation Study

Pearl Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: PT005; Drug: PT001; Drug: PT003

Study type: Interventional

Funder types: Industry

Identifiers

NCT01349816

PT003004

Details and patient eligibility

About

The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Enrollment: 185 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Signed written informed consent
• 40 - 80 years of age
• Clinical history of COPD with airflow limitation that is not fully reversible
• Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
• Current/former smokers with at least a 10 pack-year history of cigarette smoking
• A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70
• A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
• Able to change COPD treatment as required by protocol

Key Exclusion Criteria:

• Women who are pregnant or lactating
• Primary diagnosis of asthma
• Alpha-1 antitrypsin deficiency as the cause of COPD
• Active pulmonary diseases
• Prior lung volume reduction surgery
• Abnormal chest X-ray (or CT scan) not due to the presence of COPD
• Hospitalized due to poorly controlled COPD within 3 months of Screening
• Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
• Cancer that has not been in complete remission for at least 5 years
• Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives

Other inclusion/exclusion criteria as defined in the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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185 participants in 6 patient groups

PT003 (Dose 1)

Experimental group

Description:

PT003 MDI Dose 1

Treatment:

Drug: PT003

PT003 (Dose 2)

Experimental group

Description:

PT003 MDI Dose 2

Treatment:

Drug: PT003

PT003 (Dose 3)

Experimental group

Description:

PT003 MDI Dose 3

Treatment:

Drug: PT003

PT003 (Dose 4)

Experimental group

Description:

PT003 MDI Dose 4

Treatment:

Drug: PT003

PT001

Experimental group

Description:

PT001 MDI

Treatment:

Drug: PT001

PT005

Experimental group

Description:

PT005 MDI

Treatment:

Drug: PT005