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 study about?

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.

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

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Alergologia Plus Sp. z o.o. Poznan Poland
Geniko Nosokomeio Thessalonikis George Papanikolaou Thessaloniki Greece
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o. Szczecin Poland
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Hospital De Merida Merida Spain
Hospital General De Granollers Granollers Spain
Centrum Medycyny Oddechowej Mroz Sp. j. Bialystok Poland
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR Marburg Germany
Policum Berlin Studien GmbH Berlin Germany
Pneumo Studien Darmstadt GmbH Darmstadt Germany
Athens Naval Hospital Athens Greece
Asclepius Medical Center OOD Dupnitsa Bulgaria
Infer-Med Kft. Pecs Hungary
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR Berlin Germany
Thermi Clinic S.A. Thessaloniki Greece
Pro Familia Altera Sp. z o.o. Katowice Poland
POIS Sachsen GmbH Leipzig Germany
Romed Klinikum Rosenheim Rosenheim Germany
Medical Center New Rehabilitation Center EOOD Stara Zagora Bulgaria
Medical center Tara Ltd. Veliko Tirnovo Bulgaria
Balassagyarmati Dr. Kenessey Albert Korhaz Rendelointezet Balassagyarmat Hungary
Erzsebet Gondozohaz Kft. Godollo Hungary
University Of Debrecen Debrecen Hungary
Velocity Clinical Research Luebeck GmbH Luebeck Germany
University General Hospital Of Ioannina Ioannina Greece
Ospedale S G Moscati Statte Italy
Odense University Hospital Odense Denmark
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Aalborg University Hospital Aalborg Denmark
Pratia S.A. Skorzewo Poland
Siteworks GmbH Hanover Germany
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Region Midtjylland Aarhus Denmark
Hospital Vithas Xanit Internacional Benalmadena Spain
Koch Robert Korhaz Es Rendelointezet Edeleny Hungary
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Roskilde University Roskilde Denmark
Hospital Universitario Virgen De La Victoria Malaga Spain
Uztq Cyxggoea Tldifn Svm z ozov Lodz Poland
Cwmy Ayaqct Pnbvjh Ssk z oppa Warsaw Poland
Pphdl Pdzcxrs Kjsn Budapest Hungary
Hddaugxv Uhjdtbdfaedxa Mcosckk Dj Vwisrtfjtp Santander Spain
Cqn Mdk Cukdbk Plock Poland
Eyb Pjjspoxhu Stm z obon Piaseczno Poland
Cjetald Mdyimktd Kgkmgvlba Sqq z oqne Komorniki Poland
Ryoqkc &gceb Dwgvb Sjxpzom Gtvx Obertshausen Germany
Mkrrjbd Cmcqic Dgniycho 2edw Erus Yambol Bulgaria
Dtuojmlewpnnv Kmixetijvlsjl Tiwztth 1 Hehlzha Euzs Haskovo Bulgaria
Mscndwa Cpaadq Poymrwbkmkw Lvoe Sofia Bulgaria
Vrpgdyp Kdgw Szombathely Hungary
Lrmtm Gndznmf Hdtwzrzc Oj Actkkq Athens Greece
Ccobfkj Iykmmrhmefeee Thhwvoz Sfq z oxqy Piaseczno Poland
Wjuwoqqlsg Spdcwit Sxtd iif soz Rrxuta w Caexjukvm Gyncf Srxicyremzodjf Cuabpgo Czgcdg Pykm Checiny Poland
Eqbktasq Sml z oonq Karczew Poland
Pijlbqumeixkgbd Sjyvfsbvgbsudy Mro dojwuntgxmvetic Berlin Germany
Stprjy Jabpo Rywbhemcrmpfwm Hajdunanas Hungary
Hqizmo Hyyjonkv Herlev Denmark
Aujykv Mgnvayt Ckgkbw Sbul Thessaloniki Greece
Uivkjgexjh Dcozo Sbbep Dv Rnor Lk Spjmenjt Rome Italy
Pggraynzbbpuq Hhjdj Halle (Saale) Germany
Pethvvrg Pcomkjyc Lvicfvpk &stbsxy Aion Sqrdzmmejk Itnzuzxi Ktecizjh Ksawerow Poland
Kwik Gaxy Bendorf Germany
Ahakklj Sakxg Slishjgre Taziizoxxpkl Djskc Vyjpe Opcye Saronno Italy
Esbe Cnjhafj Ucffa Mnwvexwaww Eti Śfalrif Rzeszow Poland
Aoflpelvr Mgk Bibxqv Gswg Landsberg Am Lech Germany
Cocdeot Bvxso Kumhmcomiwd Afyagmerx Msema Elblag Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
10.10.2025
Denmark Denmark
Recruiting
10.10.2025
Germany Germany
Recruiting
10.10.2025
Greece Greece
Recruiting
10.10.2025
Hungary Hungary
Recruiting
10.10.2025
Italy Italy
Recruiting
10.10.2025
Poland Poland
Recruiting
10.10.2025
Spain Spain
Recruiting
10.10.2025

Trial locations

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.

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.

Trial ID:
2025-520473-40-00
Protocol code:
D7860C00006
Trial Phase:
Therapeutic exploratory (Phase II)

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