Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Product Name: AD 237 30 microgram
Product Code: AD 237
Pharmaceutical Form: Inhalation powder, hard capsule
INN or Proposed INN: Glycopyrronium bromide
CAS Number: 596-51-0
Current Sponsor code: AD 23
Sponsors
Arakis Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (a) Male or female subjects, aged 40 years and over. (b) Diagnosed with COPD, with symptoms of cough and chronic sputum production and/or dyspnea. Prior diagnoses of chronic bronchitis and/or emphysema will be accepted diagnoses of COPD. (c) Post-bronchodilator FEV1 less than or equal to 65% and greater than or equal to 30% of the predicted normal value. (d) Pre-bronchodilator FEV1/FVC ratio of =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: (a) Subjects who are pregnant or breast-feeding. Women of child-bearing potential must be willing and able to use an adequate method of contraception during the course of the study and must have a negative pregnancy test prior to receiving study drug. (b) History of asthma, atopy or allergic rhinitis, or a blood eosinophil cell count > 600 /mm3. (c) Subjects with an exacerbation of their COPD or who have had a viral infection (including upper respiratory tract infection) within 6 weeks of randomization. (d) Other relevant lung diseases (e.g., tuberculosis, bronchiolitis, alpha 1 antitrypsin deficiency, interstitial lung disease, fibrosis, sarcoidosis, cystic fibrosis). (e) History of narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction. (f) Subjects with heart failure leading to hospitalization within the past 12 months, myocardial infarction within the past 12 months or any history of cardiac arrhythmia requiring drug therapy. (g) Subjects with concurrent renal (creatinine > 1.5 x upper limit of normal [ULN]), hepatic (liver function tests > 3 x ULN) or unstable metabolic disease. (h) Subjects who, in the judgment of the investigator have a clinically significant condition such as (but not limited to) unstable ischemic heart disease or cancers (all) that might compromise subject safety or compliance, interfere with evaluation, or preclude completion of the study. (i) Subjects with abnormal laboratory values indicating an underlying unknown concomitant disease that requires further evaluation. (j) Subjects receiving inhaled corticosteroids (excluding 24-hour preparations) who have not maintained a stable dose in the 6 weeks before randomization and who are not considered to be able to maintain a stable dose during the treatment period. (k) Subjects receiving oral corticosteroids or who have taken oral corticosteroids within 6 weeks before randomization. (l) Subjects sensitive to anti-muscarinic agents. (m) Subjects requiring oxygen therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: to investigate the dose-response and efficacy of four different doses of AD 237 administered by oral inhalation once daily for 28 days in subjects with COPD compared with placebo. ;Secondary Objective: Secondary objectives: to assess the safety and tolerability of AD 237 over a range of doses; to determine plasma AD 237 levels following oral inhalation of four different AD 237 doses in subjects with COPD; and to profile the pharmacological effect of different AD 237 doses compared to the long-acting anticholinergic, tiotropium. ;Primary end point(s): Trough FEV1 at Day 28 compared to Baseline | — |
Countries
Hungary
Outcome results
None listed