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PT005 MDI Dose Ranging Versus Foradil Aerolizer Study

Information source: Pearl Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: PT005 MDI (Drug); Formoterol Fumarate 12 μg (Foradil® Aerolizer®) (Drug); Formoterol Fumarate 24 μg (Foradil® Aerolizer®) (Drug); Placebo MDI (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Pearl Therapeutics, Inc.

Summary

The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Clinical Details

Official title: A Randomized, Double-Blind, Single Dose, Six-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Three Doses of PT005, in Patients With Moderate to Severe COPD, Compared With Foradil® Aerolizer® (12 and 24 µg Open-Label) as Active Controls

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in FEV1 AUC0-12 from test day baseline across the three doses of inhaled PT005 compared with placebo

Secondary outcome:

Characterize the dose-response curve of PT005 MDI

Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events

Eligibility

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Signed written informed consent

- 40 - 80 years of age

- Clinical history of COPD with airflow limitation that is not fully reversible

- 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- bronchodilator FEV1/FVC ratio of < or = 0. 70

- A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of

predicted normal values

- Able to change COPD treatment as required by protocol

- Demonstratead reversibility to short acting beta agonist (Ventolin HFA) (> 12% and

>150 mL improvement in baseline FEV1 approximately 30 minutes following administration of 4 puffs of Ventolin HFA or > 200 mL improvement in baseline FEV1 30 minutes following administration of 2 puffs of Ventolin HFA) Key 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 3 months of Screening

- Clinically significant medical conditions that preclude participation in the study

(e. g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)

- Cancer that has not been in complete remission for at least 5 years

- Treatment with investigational study drug or participation in another clinical trial

or study within the last 30 days or 5 half lives Other inclusion/exclusion criteria as defined by the protocol

Locations and Contacts

Pearl Investigative Site, Clearwater, Florida, United States

Pearl Investigative Site, Tampa, Florida, United States

Pearl Investigative Site, Spartanburg, South Carolina, United States

Additional Information

Starting date: May 2011
Last updated: September 10, 2012

Page last updated: August 23, 2015

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