Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00880490
Last Updated: 2010-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2008-11-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
Inhaled PT005 2.4 mcg
Inhaled PT005
single dose, inhaled
2
Inhaled PT005 4.8 mcg
Inhaled PT005
single dose, inhaled
3
Inhaled PT005 9.6 mcg
Inhaled PT005
single dose, inhaled
4
Inhaled Placebo
Inhaled placebo
single dose, inhaled
5
Formoterol Fumarate 12 mcg (Foradil Aerolizer)
Formoterol Fumarate 12 mcg (Foradil Aerolizer)
single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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Pearl Therapeutics, Inc.
INDUSTRY
Responsible Party
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Pearl Therapeutics, Inc.
Principal Investigators
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Colin Reisner, M.D.
Role: STUDY_DIRECTOR
Pearl Therapeutics, Inc.
Locations
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Woolcock Institute of Medical Research
Glebe, New South Wales, Australia
Australian Clinical Research Organisation
Auchenflower, Queensland, Australia
Mater Hospital
South Brisbane, Queensland, Australia
Primorus Clinical Trials
Christchurch, , New Zealand
P3 Research
Wellington, , New Zealand
Countries
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References
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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.
Other Identifiers
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PT0050801
Identifier Type: -
Identifier Source: org_study_id