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Study of AZD6793 tablets to reduce flare-ups in adults with moderate to very severe chronic obstructive pulmonary disease (COPD)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with Chronic Obstructive Pulmonary Disease (COPD), specifically those with moderate to very severe forms of the condition. COPD is a long-term lung disease that makes it hard to breathe and causes coughing, mucus production, and shortness of breath. The study will test a new medication called AZD6793, which comes in the form of film-coated tablets taken by mouth.

The main purpose of this research is to determine if AZD6793 can reduce how often COPD symptoms get significantly worse (known as exacerbations) compared to placebo. The study will involve different groups of participants who will receive either different doses of AZD6793 or placebo tablets.

The treatment period will last 24 weeks, during which participants will take their assigned medication while continuing their regular breathing medications. Throughout the study, doctors will monitor participants' breathing ability, symptoms, quality of life, and overall health. They will also check how the body handles the medication and watch for any potential side effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
You will undergo an initial evaluation to confirm your eligibility for the study if you are 40 years or older and have been diagnosed with moderate to very severe COPD for at least 12 months
Your medical history will be reviewed, including confirmation that you have had at least 2 moderate or 1 severe COPD flare-ups in the past year
A breathing test will be performed to measure your lung function
Step 2
Study medication assignment
You will be randomly assigned to receive either AZD6793 tablets or a placebo (inactive tablet)
The medication will be in the form of film-coated tablets for oral use
You will continue your regular inhaled maintenance therapy throughout the study
Step 3
Treatment period
The study will last for 24 weeks (approximately 6 months)
You will take the study medication as prescribed while continuing your regular COPD treatments
Your breathing function will be measured at week 12 and week 24
Your symptoms will be monitored using standardized questionnaires about breathlessness, cough, and overall health status
Step 4
Monitoring and assessments
Regular health checks will include blood tests, vital signs measurements, and physical examinations
Any COPD flare-ups will be recorded throughout the study period
Your heart function will be monitored through ECG tests
Blood samples will be collected to measure the levels of study medication in your system
Step 5
Safety monitoring
Your health will be closely monitored for any side effects or health changes
Special attention will be paid to monitoring for chest infections confirmed by X-ray, skin changes, and blood cell counts
Any medical issues that occur during the study will be documented and evaluated

Who can join the trial?

9 criteria

Must be at least 40 years old when signing the consent form
Must have been diagnosed with moderate to very severe COPD (Chronic Obstructive Pulmonary Disease) for at least 12 months before joining the study
Must meet specific lung function measurements during breathing tests (FEV1/FVC and FEV1 - tests that measure how well you can exhale air)
Must have had at least 2 moderate episodes or 1 severe episode of COPD worsening in the past 12 months before screening
Must have been using either triple or dual inhaler therapy (medication combinations for COPD) regularly for at least 3 months before screening
Must have a CAT score of 10 or higher (CAT is a questionnaire that measures COPD symptoms)
Must be either a current smoker or former smoker with a history of smoking at least 10 pack-years (pack-years = number of packs smoked per day multiplied by years of smoking)
Must be clinically stable and free from COPD worsening for 4 weeks before first visit and remain stable until the start of the study
Women who can become pregnant must have a negative pregnancy test at first visit and at the start of the study

Who cannot join the trial?

15 criteria

History of asthma or other significant respiratory disorders besides COPD (Chronic Obstructive Pulmonary Disease)
Current active lung infections or tuberculosis
Major surgery within 3 months before starting the study
Severe heart problems or uncontrolled high blood pressure
History of cancer within the past 5 years (except treated skin cancer)
Liver disease or abnormal liver function tests
Kidney disease or severely reduced kidney function
Participation in another clinical trial within 30 days
Pregnancy or breastfeeding
Unable to use inhalers properly
Known allergic reactions to similar medications
Alcohol or drug abuse within the past year
Mental health conditions that could interfere with the study
Use of medications that could interact with the study drug
Unable to perform required breathing tests

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Verified sites

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Azienda Ospedaliero Universitaria Di Sassari
Responsive
Sassari, Italy
Region Midtjylland
Responsive
Aarhus, Denmark
Wojewodzki Szpital Spec im. sw. Rafala w Czerwonej Gorze Swietokrzyskie Centrum Chorob Pluc
Verified
Checiny, Poland

Trial locations

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Investigated drugs

AZD6793 is an investigational medication being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is being tested in tablet form to see if it can help reduce the frequency of moderate to severe COPD flare-ups (exacerbations). These flare-ups can make breathing more difficult for people with COPD. The medication is being compared to a placebo to determine how effective it is in managing COPD symptoms and preventing these flare-ups.

What is already known about the treatment

AZD6793 - An investigational medication being studied in clinical trials for the treatment of moderate to very severe Chronic Obstructive Pulmonary Disease (COPD), administered in tablet form. This drug is currently in Phase IIb trials to evaluate its efficacy in reducing the rate of moderate or severe COPD exacerbations compared to placebo. The medication belongs to a new class of therapeutic agents targeting respiratory conditions, though its specific molecular mechanism of action is not publicly disclosed in the available clinical trial data. The development of this drug represents ongoing research efforts to provide new treatment options for patients with COPD, a progressive respiratory disease that affects lung function.

Investigated diseases

Chronic Obstructive Pulmonary Disease (COPD) - A progressive respiratory condition that causes airflow blockage and breathing-related problems. The disease develops gradually, causing the airways to become inflamed and the lung tissue to become damaged. COPD makes breathing increasingly difficult over time, with symptoms including shortness of breath, chronic cough, and mucus production. The condition can vary in severity from moderate to very severe, with periods of symptom worsening known as exacerbations. People with COPD often experience reduced ability to perform daily activities due to breathing difficulties.