A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease.
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Glyocopyrrolate Inhalation Solution administered by Magnair; Placebo administered by Magnair
Intervention description: glycopyrrolate Inhalation Solution 25mcg, single dose; Placebo Inhalation Solution
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Randomized, Double-blind, Placebo-controlled, 2-Way Crossover Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 40 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD)

Summary:

      A clinical study to investigate if a single dose of an approved drug product (glycopyrrolate
      Inhalation Solution) reduces trapped air in the lungs of participants with chronic
      obstructive pulmonary disease. This study is accepting male and female participants over the
      age of 40. The study will be conducted at one site located in the United States.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is male or female and ≥ 40 years of age at Screening with a confirmed
             diagnosis of COPD.

        Subject must have the ability to comprehend the informed consent form and be willing to
        provide informed consent.

        Subject must possess an educational level and degree of understanding of English that
        enables them to communicate suitably with the Investigator and the study coordinator.

        Subject has a postbronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 30%
        and < 80% of predicted normal at Screening.

        Subject has a postbronchodilator (following inhalation of ipratropium bromide) FEV1/FVC
        ratio of < 0.70 at Screening.

        Subject has a RV ≥ 130% predicted value at Screening (prior to reversibility testing)
        Subject is a current or former smoker with at least 10 pack-years of cigarette smoking
        history at Screening.

        Subject has a score of ≥ 2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at
        Screening.

        Subject, if female of child bearing potential, must have a negative serum pregnancy test at
        Screening. Females of childbearing potential must be instructed to and agree to avoid
        pregnancy during the study and must use an acceptable method of birth control: a) an oral
        contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or
        injectable contraceptive for at least 30 days prior to entering the study with continued
        use throughout the study and for thirty days following participation; b) barrier method of
        contraception, eg, condom and /or diaphragm with spermicide while participating in the
        study; and/or c) abstinence. A follicle stimulating hormone (FSH) test will be used to
        confirm menopause in postmenopausal females.

        Subject is willing and able to attend all study visits and adhere to all study assessments
        and procedures.

          -  Exclusion Criteria:

        Subject is female who is pregnant or lactating or are planning on becoming pregnant during
        the study.

        Subject has a history of asthma. Subject has a blood eosinophil count > 5% of total white
        blood cell count. Subject has life-threatening/unstable respiratory status, including upper
        or lower respiratory tract infection, within the previous 30 days prior to Screening.

        Recent history of COPD exacerbation requiring hospitalization or need for increased
        treatments for COPD within 12 weeks prior to Screening.

        Use of daily oxygen therapy > 12 hours per day Subject is unable to perform
        plethysmography. Subject is unable to use the Magnair Nebulizer System. Subject has history
        of narrow angle glaucoma Subject has history of or clinically significant ongoing bladder
        outflow obstruction or history of catheterization for relief of bladder outflow obstruction
        within the previous 6 months prior to screening.

        subject has history of long QT syndrome. subject has a QTcF > 450 msec (males) or > 470
        msec (females) at Screening, unless discussed with and approved by the Medical Monitor.

        Subject has a cardiac implanted device (internal defibrillator, pacemaker). Current severe
        heart failure (New York Heart Association Class IV) [New York Heart Association, 1994].

        Subject has history of malignancies within the past 5 years, with the exception of basal
        cell carcinoma.

        Subject has known comorbidities including unstable cardiac, pulmonary, or psychiatric
        disease, or any other medical conditions that would, in the opinion of the Investigator,
        preclude the subject from safely completing the required tests or the study, or is likely
        to result in disease progression that would require withdrawal of the subject.

        Subject has participated in another investigational drug study (within 30 days prior to
        Screening).

        Subjects who are study site staff members or relatives of study site staff members.

        Subjects with a history of allergic reaction to glycopyrrolate, tiotropium, albuterol, or
        any components of the study medications.

        Subjects with a known allergy to hydrocolloid gel adhesive are excluded from wearing the
        VitalPatch Biosensor.

        -Continuation Criteria Subject has not had an exacerbation of COPD. Subject completes the
        7-day washout period and continues to withhold restricted medications.

        In the opinion of the Investigator, the subject has not had any change that would put the
        safety of the subject at risk through participation.