Study to Evaluate the Safety and Efficacy of Inhaled PT001 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Pearl Therapeutics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Inhaled Placebo; Drug: Tiotropium Handihaler; Drug: Inhaled PT001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871182

PT0010801

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of inhaled PT001 compared to placebo and tiotropium in patients with mild to moderate chronic obstructive pulmonary disease (COPD).

Enrollment: 33 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent
• 40 - 75 years of age
• Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
• COPD diagnosis
• Current/former smokers with at least a 10 pack-year history of cigarette smoking
• Patients with established clinical history of COPD and severity defined as a post-ipratropium FEV1/FVC ratio of ≤0.70 and FEV1 ≥50 and ≤85% of predicted normal at Screening
• Must demonstrate reversibility to ipratropium demonstrated by a >200 mL improvement over baseline and/or >12% and >150 mL improvement over baseline
• Patients willing to stay at study site for at least 24 hours on each test day

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 24 weeks of Screening
• Unable to perform acceptable spirometry
• Poorly controlled COPD in prior 6-weeks, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician
• Clinically significant medical conditions
• Symptomatic prostatic hypertrophy or bladder neck obstruction
• Known narrow-angle glaucoma
• Lower respiratory tract infection requiring antibiotics in past 6 weeks
• Clinically significant abnormal ECG
• Clinically significant uncontrolled hypertension
• Positive Hepatitis B surface antigen or Hepatitis C antibody
• Cancer that has not been in complete remission for at least 5 years
• History of hypersensitivity to any beta2-agonists or anticholinergics
• History of severe milk protein allergy
• Known or suspected history of alcohol or drug abuse
• Medically unable to withhold short acting bronchodilators for 6-hours
• Use of the medications below in specified time interval prior to Screening: 3 months: depot corticosteroids, intra-articular corticosteroids; 6 weeks: oral corticosteroids, antibiotics administered for a COPD exacerbation; and 1 month: P-glycoprotein inhibitors, CYP450 3A4 inhibitors, ICS >1000 μg/day of fluticasone propionate or equivalent
• The following COPD medications need to be stopped and switched to appropriate replacement therapies: tiotropium, oral beta2 agonists, LABAs, combination corticosteroid/LABAs, theophylline, leukotriene inhibitors,cromoglycate and nedocromil
• Use of the following medications is prohibited: tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, beta-adrenergic antagonists, anticonvulsants (barbiturates, hydantoins, and carbamazepine and phenothiazines
• Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day
• Diagnosis of sleep apnea that is uncontrolled
• Participation in acute phase of pulmonary rehabilitation in prior 4 weeks
• Will enter acute phase of pulmonary rehabilitation program during study
• Unable to comply with study procedures
• Affiliated with Investigator site
• Questionable validity of consent
• Use of investigational study drug/participation in clinical study in the last 30 days or 5 half lives prior to Screening, whichever is longer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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33 participants in 6 patient groups, including a placebo group

PT001 18 mcg

Experimental group

Description:

Inhaled PT001 18 mcg

Treatment:

Drug: Inhaled PT001

PT001 36 mcg

Experimental group

Description:

Inhaled PT001 36 mcg

Treatment:

Drug: Inhaled PT001

PT001 72 mcg

Experimental group

Description:

Inhaled PT001 72 mcg

Treatment:

Drug: Inhaled PT001

PT001 144 mcg

Experimental group

Description:

Inhaled PT001 144 mcg

Treatment:

Drug: Inhaled PT001

Inhaled Placebo

Placebo Comparator group

Description:

Inhaled Placebo

Treatment:

Drug: Inhaled Placebo

Tiotropium Handihaler

Active Comparator group

Description:

Tiotropium 18 mcg administered via Handihaler

Treatment:

Drug: Tiotropium Handihaler