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.

NCT04155047 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: SUN101-402
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Residual Volume (RV) at 6 Hours Postdose

  Change from baseline in Residual Volume (Residual Volume is defined as the volume of gas that remains in lungs after maximal exhalation) at 6 hours postdose.

  6 hours post dose

Study Arms (2)

Glycopyrrolate Inhalation Solution

ACTIVE COMPARATOR

Glycopyrrolate Inhalation Solution 25mcg administered by Magnair

Combination Product: Glyocopyrrolate Inhalation Solution administered by Magnair

Placebo

PLACEBO COMPARATOR

Placebo Inhalation Solution administered by Magair

Drug: Placebo administered by Magnair

Interventions

Glyocopyrrolate Inhalation Solution administered by Magnair COMBINATION_PRODUCT

glycopyrrolate Inhalation Solution 25mcg, single dose

Also known as: LONHALA

Glycopyrrolate Inhalation Solution

Placebo administered by Magnair DRUG

Placebo Inhalation Solution

Placebo

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunovion Respiratory Development Inc.: lead

Study Sites (1)

Midwest Chest Consultants

Saint Charles, Missouri, 63301, United States

Location

Related Publications (1)

• Siler TM, Hohenwarter C, Xiong K, Sciarappa K, Sanjar S, Sharma S. Efficacy of Nebulized Glycopyrrolate on Lung Hyperinflation in Patients with COPD. Pulm Ther. 2021 Dec;7(2):503-516. doi: 10.1007/s41030-021-00166-5. Epub 2021 Jul 7.

  PMID: 34232493 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Respiratory Medical Director
• Organization: Sunovion Respiratory Development Inc.

clinicaltrialdisclosure@sunovion.com

1-866-503-6351

Study Officials

• Respiratory Medical Director

  Sumitomo Pharma America, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Double-blind, Placebo-controlled, 2-Way Crossover Study

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: November 7, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: May 10, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)