PT003 MDI Cardiovascular Safety Study

Pearl Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: PT003 MDI; Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®); Drug: PT001 MDI; Drug: PT005 MDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01349803

PT003003

Details and patient eligibility

About

This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.

Enrollment: 237 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
• Acceptable baseline (Visit 2) Holter monitor recording

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
• Clinically significant abnormal findings during the baseline Holter recording
• Patients with a pacemaker or ICD/CRT/CRT_D devices

Other inclusion/exclusion criteria as defined by the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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237 participants in 4 patient groups

PT005 MDI

Experimental group

Description:

PT005 MDI

Treatment:

Drug: PT005 MDI

PT001 MDI

Experimental group

Description:

PT001 MDI

Treatment:

Drug: PT001 MDI

PT003 MDI

Experimental group

Description:

PT003 MDI

Treatment:

Drug: PT003 MDI

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Active Comparator group

Description:

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Treatment:

Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)