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Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control

P

Pearl Therapeutics

Status and phase

Withdrawn
Phase 2

Conditions

COPD

Treatments

Drug: Inhaled PT005
Drug: Inhaled Placebo
Drug: Formoterol Fumarate 12 µg (Foradil Aerolizer)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01043601
PT0051002

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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- 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
  • Competent at using the inhalation device

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 12 weeks of Screening
  • Poorly controlled COPD, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician within 6 weeks of screening or between screening and visit 2
  • Lower respiratory tract infection requiring antibiotics within 6 weeks of screening
  • Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG or 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 prohibited medications prior to screening and during the study as specified in the protocol
  • Receiving long-term-oxygen or nocturnal oxygen therapy for >12 hours a day
  • Participation in acute phase of pulmonary rehabilitation within 4 weeks of screening or will enter acute phase of pulmonary rehabilitation program during study
  • Unable to comply with study procedures
  • Prior participation in a Pearl PT005 study
  • Requires use of a spacer due to poor hand-to-breath coordination

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

0 participants in 4 patient groups, including a placebo group

Inhaled PT005 7.2 µg
Experimental group
Treatment:
Drug: Inhaled PT005
Inhaled PT005 9.6 µg
Experimental group
Treatment:
Drug: Inhaled PT005
Inhaled Placebo
Placebo Comparator group
Treatment:
Drug: Inhaled Placebo
Formoterol Fumarate 12 µg (Foradil Aerolizer)
Active Comparator group
Treatment:
Drug: Formoterol Fumarate 12 µg (Foradil Aerolizer)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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