Trial | NCT00880490  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    formoterol ...

  • Study Participants

    34
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).
Study Started
Nov 30
2008
Primary Completion
May 31
2009
Study Completion
May 31
2009
Last Update
Oct 13
2010
Estimate

Drug Inhaled PT005

single dose, inhaled

Drug Inhaled PT005

single dose, inhaled

Drug Inhaled PT005

single dose, inhaled

Drug Inhaled placebo

single dose, inhaled

Drug Formoterol Fumarate 12 mcg (Foradil Aerolizer)

single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer

  • Other names: Foradil Aerolizer

1 Experimental

Inhaled PT005 2.4 mcg

2 Experimental

Inhaled PT005 4.8 mcg

3 Experimental

Inhaled PT005 9.6 mcg

4 Placebo Comparator

Inhaled Placebo

5 Active Comparator

Formoterol Fumarate 12 mcg (Foradil Aerolizer)

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 Results Posted