Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Pearl Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: PT001 MDI; Drug: PT003 MDI; Drug: PT005 MDI; Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®); Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®); Drug: Placebo MDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01085045

PT0031002

Details and patient eligibility

About

The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.

Enrollment: 118 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

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 protocol defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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118 participants in 8 patient groups, including a placebo group

Inhaled PT003 (Dose 1)

Experimental group

Description:

PT003 MDI Dose 1

Treatment:

Drug: PT003 MDI

Inhaled PT003 (Dose 2)

Experimental group

Description:

PT003 MDI Dose 2

Treatment:

Drug: PT003 MDI

Inhaled PT005 (Dose 1)

Experimental group

Description:

PT005 MDI Dose 1

Treatment:

Drug: PT005 MDI

Inhaled PT005 (Dose 2)

Experimental group

Description:

PT005 MDI Dose 2

Treatment:

Drug: PT005 MDI

Inhaled Placebo

Placebo Comparator group

Description:

Placebo MDI

Treatment:

Drug: Placebo MDI

Tiotropium bromide 18 μg (Spiriva Handihaler®)

Active Comparator group

Description:

Tiotropium Bromide inhalation powder

Treatment:

Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®)

Formoterol Fumarate 12 μg (Foradil® Aerolizer®)

Active Comparator group

Description:

Formoterol fumarate inhalation powder 12 μg

Treatment:

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

Inhaled PT001 (Dose 1)

Experimental group

Description:

PT001 MDI Dose 1

Treatment:

Drug: PT001 MDI