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

NCT00880490 | Completed Phase 1

• 1 other identifier: PT0050801
• Study Type: interventional
• Target: 34
• Locations: 2 countries
• Sites: 5

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).

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (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.

  Serial FEV1 measured over 12 hours

Secondary Outcomes (6)

• Time to onset of action (>10% improvement in FEV1 from baseline)

  Serial FEV1 measured over 12 hours

• Peak FEV1

  Serial FEV1 measured over 12 hours

• Trough FEV1

  Serial FEV1 measured over 12 hours

• Peak inspiratory capacity (IC)

  Serial IC measured over 12 hours

• Peak expiratory flow rate (PEFR)

  Serial PEFR measured over 12 hours

Study Arms (5)

1

EXPERIMENTAL

Inhaled PT005 2.4 mcg

Drug: Inhaled PT005

2

EXPERIMENTAL

Inhaled PT005 4.8 mcg

Drug: Inhaled PT005

3

EXPERIMENTAL

Inhaled PT005 9.6 mcg

Drug: Inhaled PT005

4

PLACEBO COMPARATOR

Inhaled Placebo

Drug: Inhaled placebo

5

ACTIVE COMPARATOR

Formoterol Fumarate 12 mcg (Foradil Aerolizer)

Drug: Formoterol Fumarate 12 mcg (Foradil Aerolizer)

Interventions

Inhaled PT005 DRUG

single dose, inhaled

1

Inhaled placebo DRUG

single dose, inhaled

4

Formoterol Fumarate 12 mcg (Foradil Aerolizer) DRUG

single dose, Formoterol Fumarate 12 mcg administered via the Aerolizer

Also known as: Foradil Aerolizer

5

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (5)

Woolcock Institute of Medical Research

Glebe, New South Wales, 2037, Australia

Location

Australian Clinical Research Organisation

Auchenflower, Queensland, 4066, Australia

Location

Mater Hospital

South Brisbane, Queensland, 4101, Australia

Location

Primorus Clinical Trials

Christchurch, 8014, New Zealand

Location

P3 Research

Wellington, 6035, New Zealand

Location

Related Publications (1)

• 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.

  PMID: 25060541 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Colin Reisner, M.D.

  Pearl Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 9, 2009
• First Posted: April 13, 2009
• Study Start: November 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: October 13, 2010

Record last verified: 2010-10

Locations

NZ (2); AU (3)