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.
Source: ClinicalTrials.gov NCT04155047 ↗Summary
Linked Publications
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Efficacy of Nebulized Glycopyrrolate on Lung Hyperinflation in Patients with COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Residual Volume (RV) at 6 Hours Postdose |
0.004; -0.319 | 0.0987 |
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 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.
Data sourced from ClinicalTrials.gov (NCT04155047) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.