Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients with Chronic Obstructive Pulmonary Disease (COPD)

Study identifier:PT0050801

ClinicalTrials.gov identifier:NCT00880490

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-blind, Five-period, Placebo and Active-controlled,Cross-over, Multi-centre, Study Evaluating Single Administration of Three Doses of inhaled PT005 in Patients with Moderate-to-Severe COPD, Compared to Open- Label Marketed Formoterol (FORADIL® AEROLIZER®) as an Active Control

Medical condition

Chronic Obstructive Pulmonary Disease

Phase

Phase 1/2

Healthy volunteers

Study drug

Inhaled PT005, Inhaled placebo, Formoterol Fumarate 12 mcg (Foradil Aerolizer)

Sex

All

Actual Enrollment

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 01 Nov 2008

Primary Completion Date: 01 May 2009

Study Completion Date: 01 May 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2016 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Signed written informed consent
- 40 - 80 years of age
- Fluency in written and spoken English
- 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-salbutamol FEV1/FVC ratio of < or = 0.70
- A measured post-salbutamol FEV1 > or = 40 and < or = 80% of
predicted normal values
- Demonstrated reversibility to a short acting beta agonist by either >12% and >150 ml improvement in baseline FEV1, 30 minutes following administration of
4 puffs of salbutamol MDI or an absolute improvement of >200 ml in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol MDI.
- Competent at using the inhalation device

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
- 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
- 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 any study drug component
- History of severe milk protein allergy
- Known or suspected history of alcohol or drug abuse
- Medically unable to withhold short acting bronchodilators for 8-hours
- Use of the medications below in specified time interval prior to Screening: 12-weeks: depot corticosteroids, intra-articular corticosteroids; 4 weeks: ICS >1000 μg/day of fluticasone propionate or equivalent, non-potassium sparing diuretics, P-glycoprotein inhibitors, CYP3A4 inhibitors; 1 week: tiotropium; 48 hours: oral beta agonists, long acting beta agonists, theophylline, zariflukast, montelukast, zileuton; 8 hours: ipratropium or ipratropium/salbutamol combination product, inhaled short acting beta agonists, xanthine containing foods
- 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 or will enter acute phase of pulmonary rehabilitation program during study
- Unable to comply with study procedures
- Affiliated with Investigator site
- Questionable validity of consent
- A positive drug of abuse test at Screening
lives prior to Screening, whichever is longer

No locations available

Arms	Assigned Interventions
Experimental: 1 Inhaled PT005 2.4 mcg	Drug: Inhaled PT005 single dose, inhaled
Experimental: 2 Inhaled PT005 4.8 mcg	Drug: Inhaled PT005 single dose, inhaled
Experimental: 3 Inhaled PT005 9.6 mcg	Drug: Inhaled PT005 single dose, inhaled
Placebo Comparator: 4 Inhaled Placebo	Drug: Inhaled placebo single dose, inhaled
Active Comparator: 5 Formoterol Fumarate 12 mcg (Foradil Aerolizer)	Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer) single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer Other Name: Foradil Aerolizer

Documents available

Trial Results Summaries
Available here

Contacts

Contact

Caron Hookway

+61 7 3331 3933

[email protected]

Investigators

Principal Investigator

Colin Reisner

Pearl Therapeutics, Inc.