Health Trials

A Study to Investigate the Effect of AZD6793 in Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

ConditionChronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorAstraZeneca

About this trial

This Phase IIb dose-ranging study will evaluate the efficacy and safety of 2 different doses of AZD6793 compared with placebo tablets in participants with moderate to very severe chronic obstructive pulmonary disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Clinically important pulmonary disease other than COPD (eg, asthma [current diagnosis per GINA or other accepted guidelines], active pulmonary infection, clinically significant bronchiectasis when bronchiectasis is the predominant diagnosis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 antitrypsin deficiency or primary ciliary dyskinesia).

Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant's respiratory symptoms.

Any unstable disorder, including, but not limited to, CV, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric disorder, major physical and/or cognitive impairment.

Significant left heart failure.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD6793

    Drug

    Oral dosage

  • Placebo

    Other intervention

    Oral dosage

Treatment groups

987 Participants
are divided into 3 treatment groups
Group A: Dose 1 of AZD6793Experimental treatment 1 intervention
Group B: Dose 2 of AZD6793Experimental treatment 1 intervention
Group C: Matching PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Annualised rate of moderate or severe COPD exacerbations

The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 24 Weeks treatment period compared to placebo

Time frame
From baseline up to 24 Weeks

Secondary outcomes

1

Time to first moderate or severe COPD exacerbation

To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks

Time frame
From baseline up to 24 Weeks
2

Annualised rate of COPD exacerbations associated with emergency room visits, urgent care visits, or hospitalisations

To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks

Time frame
From baseline up to 24 Weeks
3

Annualised rate of severe COPD exacerbations

To evaluate the effect of AZD6793 as compared to placebo on COPD exacerbations from baseline up to 24 Weeks

Time frame
From baseline up to 24 Weeks
4

Annualised rate of COPDCompEx events

To evaluate the effect of AZD6793 as compared to placebo on COPDCompEx events from baseline up to 24 Weeks

Time frame
From baseline up to 24 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
Apply now