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

NCT00871182 | Completed Phase 1

• 1 other identifier: PT0010801
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; obstructive lung diseases; Tiotropium

Outcome Measures

Primary Outcomes (1)

• Peak improvement in forced expiratory volume in one second (FEV1)

  Day 1 serial FEV1 measured over 24 hours

  Day 1

Secondary Outcomes (6)

• Time to onset of action (>10% improvement in FEV1 from baseline)

  Day 1

• Time to peak FEV1

  Day 1

• FEV1 area under the curve (AUC) from 0 to 24 hours

  Day 1

• FEV1 AUC from 0 to 12 hours

  Day 1

• Trough FEV1 at 12 and 24 hours

  Day 1

Study Arms (6)

PT001 18 mcg

EXPERIMENTAL

Inhaled PT001 18 mcg

Drug: Inhaled PT001

PT001 36 mcg

EXPERIMENTAL

Inhaled PT001 36 mcg

Drug: Inhaled PT001

PT001 72 mcg

EXPERIMENTAL

Inhaled PT001 72 mcg

Drug: Inhaled PT001

PT001 144 mcg

EXPERIMENTAL

Inhaled PT001 144 mcg

Drug: Inhaled PT001

Inhaled Placebo

PLACEBO COMPARATOR

Inhaled Placebo

Drug: Inhaled Placebo

Tiotropium Handihaler

ACTIVE COMPARATOR

Tiotropium 18 mcg administered via Handihaler

Drug: Tiotropium Handihaler

Interventions

Inhaled PT001 DRUG

single dose, inhaled

PT001 144 mcg; PT001 18 mcg; PT001 36 mcg; PT001 72 mcg

Inhaled Placebo DRUG

single dose, inhaled

Inhaled Placebo

Tiotropium Handihaler DRUG

single dose, tiotropium 18 mcg administered via the Handihaler

Also known as: Spiriva

Tiotropium Handihaler

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (6)

Pivotal Research Centers

Peoria, Arizona, 85381, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Elite Research Institute

Miami, Florida, 33169, United States

Location

Pulmonary and Critical Care Medicine

Omaha, Nebraska, 68198, United States

Location

Cincinnati VAMC

Cincinnati, Ohio, 45220, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (1)

• Rennard S, Fogarty C, Reisner C, Fernandez C, Fischer T, Golden M, Rose ES, Darken P, Tardie G, Orevillo C. Randomized study of the safety, pharmacokinetics, and bronchodilatory efficacy of a proprietary glycopyrronium metered-dose inhaler in study patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2014 Jul 16;14:118. doi: 10.1186/1471-2466-14-118.

  PMID: 25027304 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Colin Reisner, M.D.

  Pearl Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2009
• First Posted: March 30, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

US (6)