- A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT07082738.
- This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.
- Sponsor: AstraZeneca.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
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This Phase IIb dose-ranging study will evaluate the efficacy and safety of 3 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.
- : * Participant must be ≥40 years of age at the time of signing the informed consent. * Documented primary diagnosis of COPD for at least 12 months prior to enrolment. * Pre-BD FEV1/FVC < 0.7 at Visit 1 and pre- and post-BD FEV1/FVC < 0.7, and post-BD FEV1 ≥ 25% to < 80% of predicted normal at Visit 2. * Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations in the 12 months prior to screening. * Documented stable regimen of inhaled triple maintenance therapy or inhaled dual maintenance therapy for ≥ 3 months prior to screening. * CAT score ≥ 10 at Visit 1. * Current or ex-smokers with a cigarette smoking history of ≥ 10 pack-years. * Participants who are clinically stable and free from an exacerbation of COPD for 4 weeks prior to Visit 1 and are also exacerbation free for at least 4 weeks (28 days) prior to Visit 3 (randomisation). * Negative pregnancy test at Visit 1 and Visit 3 for Women Of Child-Bearing Potential (WOCBP).
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.