Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lupin, Inc.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and non-pregnant female subjects (40 years of age and older).
Patients with diagnosis of COPD according to the GOLD guidelines.
Post-bronchodilator FEV1 \<80% of the predicted value at the screening visit.
Post-bronchodilator FEV1/FVC ratio ≤0.70 at the screening visit.
Current or former smokers (e.g., with history of = 10 pack-years).
Written informed consent.
You may not be if
Known respiratory disorder other than COPD including, but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
Hospitalization for COPD or pneumonia within 12 weeks prior to the screening visit.
Treatment for COPD exacerbation within 12 weeks prior to the screening visit.
Viral or bacterial upper or lower respiratory tract infection, sinusitis, sinus infection, rhinitis, pharyngitis, middle ear infection, urinary tract infection, or illness within 6 weeks prior to the screening visit.
Abnormal and significant ECG finding prior to the screening, during the run-in and treatment periods.
