Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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ClinicalTrials.gov Identifier: NCT00880490 |
Recruitment Status
:
Completed
First Posted
: April 13, 2009
Last Update Posted
: October 13, 2010
|
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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 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 |
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
|
- 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 ]
- Time to onset of action (>10% improvement in FEV1 from baseline) [ Time Frame: Serial FEV1 measured over 12 hours ]
- Peak FEV1 [ Time Frame: Serial FEV1 measured over 12 hours ]
- Trough FEV1 [ Time Frame: Serial FEV1 measured over 12 hours ]
- Peak inspiratory capacity (IC) [ Time Frame: Serial IC measured over 12 hours ]
- Peak expiratory flow rate (PEFR) [ Time Frame: Serial PEFR measured over 12 hours ]
- Forced vital capacity (FVC) [ Time Frame: Serial FVC measured over 12 hours ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880490
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 |
Study Director: | Colin Reisner, M.D. | Pearl Therapeutics, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |