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Completed

NCT Number: NCT02937584

A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD

To assess the effect of treatment with Glycopyronnium (GP) MDI administered twice daily (BID) and Formoterol Fumarate (FF) MDI administered BID on specific image-based airway volumes and resistance in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) following chronic dosing after approximately two weeks treatment.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Edegem, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative urine pregnancy test at Visit 1, and agrees to use acceptable contraceptive methods used consistently and correctly
  • Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
  • Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
  • At Visit 1, FEV1/FVC ratio must be <0.70
  • At Visit 1, post-bronchodilator FEV1must be >30% and <80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (NHANES III) reference equations.

Exclusion criteria

  • Significant diseases other than COPD, i.e., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
  • Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
  • Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
  • Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).
  • Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the run-in period (Visit 1 to Visit 2).
  • Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated.
  • Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.

Treatment and study plan

GP MDI (PT001) 14.4 μg

Drug

Glycopyrronium

FF MDI (PT005) 9.6 μg

Drug

Formoterol Fumarate

Primary outcomes

  1. Specific Image-Based Airway Volume (siVaw)

    Time frame: Baseline, Day 15

    Specific image-based airway volume. Average across lobe, adjusted for lobe volume. Ratio to baseline

  2. Specific Image-based Airway Resistance (siRaw)

    Time frame: Baseline, Day 15

    Specific image-based airway resistance (siRaw). Average across lobes, adjusted for lobe volume. Ratio to baseline.

Secondary outcomes

  1. Image-based Airway Volume (iVaw)

    Time frame: Baseline, Day 15

    Image-based airway volume (iVaw) without correction for lobe volume. Ratio to baseline.

  2. Image-based Airway Resistance (iRaw)

    Time frame: Baseline, Day 15

    Image-based airway resistance (iRaw) without correction for lobe volume. Ratio to baseline.

  3. FEV1

    Time frame: Baseline, Day 15

    FEV1 Change from baseline in Forced Expiratory Volume at 1 second.

  4. Functional Residual Capacity (FRC)

    Time frame: Baseline, Day 15

    Functional residual capacity (FRC). Ratio to baseline.

Sponsors and collaborators

Lead sponsor

Pearl Therapeutics, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Multi-Center Study to Evaluate the Effects of PT001 and PT005 on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 18, 2016
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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