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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Randomized, Double-blind, Single Dose, Four-period, Six-treatment, Placebo-controlled, Balanced, Incomplete Block, Cross-over, Study of Four Doses of Inhaled PT001 in Patients With Mild to Moderate COPD, Compared to Open Label Tiotropium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871182
• Other study ID #: PT0010801
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 26, 2009
• Last updated: June 12, 2013
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: June 2013
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Inhaled PT001
single dose, inhaled
• Inhaled Placebo
single dose, inhaled
• Tiotropium Handihaler
single dose, tiotropium 18 mcg administered via the Handihaler

Locations

Country	Name	City	State
United States	Cincinnati VAMC	Cincinnati	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Elite Research Institute	Miami	Florida
United States	Pulmonary and Critical Care Medicine	Omaha	Nebraska
United States	Pivotal Research Centers	Peoria	Arizona
United States	Spartanburg Medical Research	Spartanburg	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak improvement in forced expiratory volume in one second (FEV1)	Day 1 serial FEV1 measured over 24 hours	Day 1	No
Secondary	Time to onset of action (>10% improvement in FEV1 from baseline)	Day 1 serial FEV1 measured over 24 hours	Day 1	No
Secondary	Time to peak FEV1	Day 1 serial FEV1 measured over 24 hours	Day 1	No
Secondary	FEV1 area under the curve (AUC) from 0 to 24 hours	Day 1 serial FEV1 measured over 24 hours	Day 1	No
Secondary	FEV1 AUC from 0 to 12 hours	Day 1 serial FEV1 measured over 24 hours	Day 1	No
Secondary	Trough FEV1 at 12 and 24 hours	Day 1 serial FEV1 measured over 24 hours	Day 1	No
Secondary	Peak Improvement in inspiratory capacity (IC)	Day 1 serial IC measured over 24 hours	Day 1	No