Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-24 @ 1:56 PM
NCT ID:
NCT05046795
Eligibility Criteria:
Inclusion Criteria:
* Key inclusion criteria include:
* Males and females of Chinese ethnicity, at least 40 years of age. Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be using an acceptable, highly effective method of contraception and have a negative pregnancy test at screening.
* A clinical diagnosis for at least 6 months prior to screening of COPD according to Global Initiative for Chronic Obstructive Lung Disease(GOLD) guidelines.
* Subject is capable of performing reproducible spirometry maneuvers as described by current American Thoracic Society/European Respiratory Society (ATS/ERS) Guidelines and has a post-ipratropium (500 mcg nebulized) Forced Expiratory Volume in
1 second(FEV1)/Forced Vital Capacity(FVC) ratio \<0.7 at Visit 2.
* Subject has moderate to very severe COPD with a post-ipratropium (500 mcg nebulized) FEV1 less than 80% of predicted normal (using the Global Lung Function Initiative reference range; ) and an absolute FEV1 \>700 mL at Visit 2
* Current smoker or ex-smoker, with a history of at least 10 pack-years of tobacco smoking. Ex-smokers must have stopped smoking \>6 months prior to Visit 1.
Exclusion Criteria:
* Key exclusion criteria include:
* Previously dosed with Revefenacin.
* Current diagnosis of asthma.
* Alpha-1 anti-trypsin deficiency.
* Other chronic or active respiratory disorder (e.g., clinically significant \[as determined by the Investigator\] bronchiectasis, pulmonary fibrosis, sarcoidosis, pneumoconiosis, active tuberculosis).
* Symptoms of, or treatment for an Acute Exacerbation of COPD(AECOPD) requiring antibiotics and/or oral/systemic corticosteroids or in-patient hospitalization during the 28 days preceding screening or during the screening period between Visit 1 and Visit 3.
* Pneumonia requiring hospitalization within 28 days prior to screening or during the screening period between Visit 1 and Visit 3.
* Lower respiratory tract infection requiring treatment with antibiotics during the 28 days preceding screening or during the screening period between Visit 1 and Visit 3.
* History or presence of pulmonary hypertension, respiratory failure, cor pulmonale or right ventricular failure which may impact the safety of the subject in the clinical judgement of the Investigator.
* History of pulmonary lobectomy, lung volume reduction surgery, or lung transplantation.
* Use of supplemental oxygen therapy for more than 15 hours per day (includes night-time use).
* Subjects with hepatic impairment.
* Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention.
* Subjects who are unable to stop any of the following medications, and refrain from their use throughout the study until the final dose of study drug:
* Short-acting β2 agonists (except study-supplied salbutamol).
* Short-acting anticholinergic agents (except those used for reversibility testing).
* Long-acting anticholinergics (except study supplied medication).
* Combination β2 agonists/anticholinergic agents.
* Combination β2 agonists/inhaled corticosteroids/anticholinergic agents.
* Phosphodiesterase 4 inhibitors.
* Theophyllines.
* Leukotriene inhibitors.
* Orally inhaled nedocromil or cromolyn sodium.
* Oral or parenteral corticosteroids.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05046795
Study Brief:
Protocol Section:
NCT05046795