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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155047
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Combination Product: Glyocopyrrolate Inhalation Solution administered by Magnair Drug: Placebo administered by Magnair Phase 4

Detailed Description:

This is a single center, randomized, double-blind, placebo-controlled, single-dose, 2-way crossover study in approximately 20 adult subjects ≥ 40 years of age with COPD. The study is designed to evaluate the effect of a single dose of GIS on lung hyperinflation. The two study treatments, both administered using the Magnair device.

The study will randomize 10 subjects per treatment sequence, for a total of 20 subjects. At the Sponsor's discretion, additional subjects may be enrolled in an effort to achieve at least 20 completers, with no more than 24 subjects randomize.

The study will consist of a Screening period, a randomized 2-way cross-over treatment period during which subjects will receive two single-doses each separated by a 7-day washout period, and a follow-up 7 (± 2) days after the last study drug dose.

This study is designed to test the hypothesis that in adults with COPD subjects as characterized by the study inclusion/exclusion criteria, after 2 cross-over periods of treatment, the primary null hypothesis for this study is that the mean change of RV from baseline at 6 hours postdose for a single dose of GIS is equal to the mean change of RV from baseline at 6 hours postdose for a single dose of placebo inhalation solution (PIS). The alternative hypothesis is that these means are different.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
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)
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Placebo-controlled, 2-Way Crossover Study of the Effect of a Single Dose of Glycopyrrolate Inhalation Solution (GIS) on Lung Hyperinflation in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : November 7, 2019
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Active Comparator: Glycopyrrolate Inhalation Solution
Glycopyrrolate Inhalation Solution 25mcg administered by Magnair
Combination Product: Glyocopyrrolate Inhalation Solution administered by Magnair
glycopyrrolate Inhalation Solution 25mcg, single dose
Other Name: LONHALA

Placebo Comparator: Placebo
Placebo Inhalation Solution administered by Magair
Drug: Placebo administered by Magnair
Placebo Inhalation Solution




Primary Outcome Measures :
  1. Change from baseline in Residual Volume (RV) at 6 hours postdose [ Time Frame: 6 hours post dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155047


Locations
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United States, Missouri
Midwest Chest Consultants
Saint Charles, Missouri, United States, 63301
Sponsors and Collaborators
Sunovion Respiratory Development Inc.
Investigators
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Study Chair: Respiratory Medical Director Sunovion
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Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT04155047    
Other Study ID Numbers: SUN101-402
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study may be made available upon request via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: IPD will be made available upon request within 12 months of posting the study results on ct.gov.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Sunovion Respiratory Development Inc.:
Chronic Obstructive Pulmonary Disease (COPD)
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases