PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD

Pearl Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Tiotropium Bromide; Drug: PT001 MDI; Drug: PT001 Placebo MDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01566773

PT001003

Details and patient eligibility

About

The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.

Full description

The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.

Enrollment: 140 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 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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140 participants in 8 patient groups, including a placebo group

PT001 MDI (Dose 1)

Experimental group

Treatment:

Drug: PT001 MDI

PT001 MDI (Dose 2)

Experimental group

Treatment:

Drug: PT001 MDI

PT001 MDI (Dose 3)

Experimental group

Treatment:

Drug: PT001 MDI

PT001 MDI (Dose 4)

Experimental group

Treatment:

Drug: PT001 MDI

PT001 MDI (Dose 5)

Experimental group

Treatment:

Drug: PT001 MDI

PT001 MDI (Dose 6)

Experimental group

Treatment:

Drug: PT001 MDI

PT001 Placebo MDI

Placebo Comparator group

Treatment:

Drug: PT001 Placebo MDI

Spiriva® Handihaler® (Tiotropium Bromide)

Active Comparator group

Treatment:

Drug: Tiotropium Bromide