At a glance
ClinicalIndex Comparison Record- ✓Age 40 to 80 years (both inclusive) at Screening
- ✓Established COPD diagnosis for >1 year per GOLD 2016 guidelines
- ✓Current or former smoker with ≥10 pack-year history; former smokers must have quit ≥6 months prior to Screening
- ✓Post-bronchodilator FEV1/FVC ratio <70% after salbutamol 400 µg at Visit 2 (re-testable through Day 14)
- ✕Current diagnosis of asthma (in the Investigator's opinion)
- ✕Alpha-1 antitrypsin deficiency as the cause of COPD
- ✕Other active pulmonary diseases: active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnoea (allergic rhinitis allowed)
- ✕Lung volume reduction surgery, lobectomy, or bronchoscopic lung volume reduction within 1 year of Screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIa, Randomised, Multi-Centre, Double-Blind, Placebo-Controlled, 3 Periods, Crossover Study to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability of Inhaled AZD8871 Administered Once Daily for 2 Weeks in Patients With Moderate to Severe COPD.
In Brief
A Phase 2 clinical trial evaluating AZD8871 100 µg, AZD8871 600 µg, and 1 other intervention for Chronic Obstructive Pulmonary Disease COPD. Completed, enrolled 42 participants across 2 sites in 2 countries.
Detailed Summary
This is a study to evaluate the effects of AZD8871 in patients with COPD. Adult male or female patients with moderate to severe COPD, who agree to be in this study, will receive 3 treatments, i.e. 2 different doses of AZD8871 and placebo (dummy medication containing no drug) at once a day for 2 weeks, in a random order. To make the comparison between AZD8871 and placebo as fair as possible, this study is "double blinded." This means that neither patient nor the study doctor will know in which order the 3 treatments will be given. This study will include patients who are between 40 and 80 years of age. In total there will be 42 patients participating in this study at two study centers in the United Kingdom and Germany. The study will have a total of 12 visits for each patient spanning for a period of 4 to 6 months. The study is anticipated to run for approximately 8 months and should not exceed 10 months.
Study Details
Timeline
Interventions
The subjects will receive one dose of AZD8871 100 µg single dose DPI.
The subjects will receive AZD8871, 600 µg single dose DPI.
The subject will receive Placebo single dose DPI.