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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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).

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Inhaled PT005; Drug: Inhaled placebo; Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer)	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	34 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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
Study Start Date :	November 2008
Actual Primary Completion Date :	May 2009
Actual Study Completion Date :	May 2009

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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. [ Time Frame: Serial FEV1 measured over 12 hours ]

Secondary Outcome Measures :

1. Time to onset of action (>10% improvement in FEV1 from baseline) [ Time Frame: Serial FEV1 measured over 12 hours ]
2. Peak FEV1 [ Time Frame: Serial FEV1 measured over 12 hours ]
3. Trough FEV1 [ Time Frame: Serial FEV1 measured over 12 hours ]
4. Peak inspiratory capacity (IC) [ Time Frame: Serial IC measured over 12 hours ]
5. Peak expiratory flow rate (PEFR) [ Time Frame: Serial PEFR measured over 12 hours ]
6. Forced vital capacity (FVC) [ Time Frame: Serial FVC measured over 12 hours ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Australia, New South Wales
Woolcock Institute of Medical Research
Glebe, New South Wales, Australia, 2037
Australia, Queensland
Australian Clinical Research Organisation
Auchenflower, Queensland, Australia, 4066
Mater Hospital
South Brisbane, Queensland, Australia, 4101
New Zealand
Primorus Clinical Trials
Christchurch, New Zealand, 8014
P3 Research
Wellington, New Zealand, 6035

Sponsors and Collaborators

Pearl Therapeutics, Inc.

Investigators

Study Director:	Colin Reisner, M.D.	Pearl Therapeutics, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Quinn D, Seale JP, Reisner C, Fischer T, Golden M, Fernandez C, Darken P, St Rose E, Thomas M, Tardie G, Orevillo C. A randomized study of formoterol fumarate in a porous particle metered-dose inhaler in patients with moderate-to-severe COPD. Respir Med. 2014 Sep;108(9):1327-35. doi: 10.1016/j.rmed.2014.06.009. Epub 2014 Jul 3. Erratum in: Respir Med. 2015 Oct;109(10):1369.

Responsible Party:	Chief Medical Officer, Pearl Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00880490 History of Changes
Other Study ID Numbers:	PT0050801
First Posted:	April 13, 2009
Last Update Posted:	October 13, 2010
Last Verified:	October 2010

Keywords provided by Pearl Therapeutics, Inc.:

COPD

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Formoterol Fumarate; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs	Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action