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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880490
• Other study ID #: PT0050801
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 9, 2009
• Last updated: October 11, 2010
• Start date: November 2008
• Est. completion date: May 2009

Study information

• Verified date: October 2010
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeNew Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 compared to placebo and Formoterol Fumarate (Foradil Aerolizer) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

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 PT005
single dose, inhaled
• Inhaled PT005
single dose, inhaled
• Inhaled PT005
single dose, inhaled
• Inhaled placebo
single dose, inhaled
• Formoterol Fumarate 12 mcg (Foradil Aerolizer)
single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer

Locations

Country	Name	City	State
Australia	Australian Clinical Research Organisation	Auchenflower	Queensland
Australia	Woolcock Institute of Medical Research	Glebe	New South Wales
Australia	Mater Hospital	South Brisbane	Queensland
New Zealand	Primorus Clinical Trials	Christchurch
New Zealand	P3 Research	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline across the three doses of inhaled PT005 compared with placebo.		Serial FEV1 measured over 12 hours	No
Secondary	Time to onset of action (>10% improvement in FEV1 from baseline)		Serial FEV1 measured over 12 hours	No
Secondary	Peak FEV1		Serial FEV1 measured over 12 hours	No
Secondary	Trough FEV1		Serial FEV1 measured over 12 hours	No
Secondary	Peak inspiratory capacity (IC)		Serial IC measured over 12 hours	No
Secondary	Peak expiratory flow rate (PEFR)		Serial PEFR measured over 12 hours	No
Secondary	Forced vital capacity (FVC)		Serial FVC measured over 12 hours	No