Study of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) to Reduce Disease Flare-ups

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What is this study about?

This study focuses on Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that causes breathing difficulties. The research examines the effectiveness of a medication called tezepelumab, which is given as an injection under the skin, compared to placebo in adults with moderate to very severe forms of the disease.

The main purpose of this study is to determine if tezepelumab can reduce the number of COPD flare-ups (also called exacerbations) in patients. During the study, participants will receive either tezepelumab or placebo through subcutaneous injection using a pre-filled syringe. The treatment period will last for approximately 76 weeks.

The medication being tested, tezepelumab (also known as MEDI9929), is already approved for other uses and is being studied to understand if it can help people with COPD. Throughout the study, doctors will monitor how well the treatment works and check for any side effects. Participants will need to continue using their regular COPD medications during the study period.

1 Initial screening and qualification

Your eligibility for the study will be assessed based on specific health criteria

Medical tests will be performed, including lung function tests to measure your FEV1 (amount of air you can exhale in one second)

Your medical history of COPD (chronic lung disease) will be reviewed

Blood tests will check your eosinophil level (type of white blood cell)

2 Treatment assignment

You will be randomly assigned to receive either Tezspire or a placebo (inactive substance)

Neither you nor your doctor will know which treatment you are receiving

The medication will be given as an injection under the skin (subcutaneous injection)

3 Treatment period

The study will last for 76 weeks (approximately 1.5 years)

You will receive regular injections of either Tezspire 210 mg or placebo

Your current inhaled medications for COPD will be continued as prescribed

4 Monitoring and assessments

Regular clinic visits to check your lung function

Completion of questionnaires about your symptoms and quality of life

Monitoring of any breathing problems or COPD flare-ups

Blood samples will be collected to measure drug levels and check for antibodies

Your overall health and any side effects will be monitored throughout the study

5 Final evaluation

Final assessment of your lung function and symptoms at week 76

Review of any breathing problems or COPD flare-ups during the study period

Final blood tests and health checks

Completion of final quality of life questionnaires

Who Can Join the Study?

  • Age between 40 and 80 years old at the time of signing consent
  • Must have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease) by a doctor for at least 12 months before first visit
  • Must have specific lung function test results showing:
    – A reduced ratio of exhaled air volume (FEV1/FVC ratio less than 0.70)
    – Lung capacity between 20% and 70% of normal predicted value after using bronchodilator medication
  • Must be using prescribed inhalers regularly for at least 3 consecutive months, either:
    – Three different types combined (steroid + two types of bronchodilators), or
    – Two different types combined (any combination of steroid and bronchodilators)
  • History of either:
    – At least 2 moderate COPD flare-ups, or
    – At least 1 severe COPD flare-up in the past 12 months
    At least one moderate flare-up must have been treated with steroids
  • Must have a blood test showing eosinophil count of 150 cells or higher during screening
  • Must score 15 or higher on the COPD Assessment Test (CAT), which measures COPD symptoms
  • Must be either:
    – Current smoker, or
    – Former smoker who quit at least 6 months before first visit
    With history of smoking at least 10 pack-years (equivalent to smoking 20 cigarettes daily for 10 years)

Who Cannot Join the Study?

  • History of asthma or current diagnosis of asthma (a chronic condition that affects breathing and causes wheezing)
  • Current active lung infection or any other significant lung disease besides COPD
  • Use of immunosuppressive medications (drugs that lower the body’s immune response) within 3 months before the study
  • History of cancer within the past 5 years, except for successfully treated skin cancer
  • Serious heart conditions or uncontrolled high blood pressure
  • Liver disease or abnormal liver function tests
  • Kidney disease or significantly reduced kidney function
  • Current smokers or those who quit smoking less than 6 months ago
  • Participation in another clinical trial within the past 30 days
  • Previous treatment with tezepelumab or similar medications
  • History of severe allergic reactions to any medications
  • Pregnant women or women planning to become pregnant during the study
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium
Medical Center St. Ivan Rilski Chudotvorets 2010 EOOD Plovdiv Bulgaria
Simplex Kft. Nyiregyhaza Hungary
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Sofia Bulgaria
Karolinska University Hospital Solna Sweden
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
BKS Research Kft. Hatvan Hungary
Neoclinic Concept S.R.L. Timisoara Romania
Ujaxqsxonx Oe Dfffxwgp Debrecen Hungary
Odzuzzcwi Eybsgm Krxk Mosonmagyaróvár Hungary
Lurya Gxsuhsj Hzbjznbi Ow Amniag Athens Greece
Mdtwrtb Cmolhq Pujqvrpcajb Lwrt Sofia Bulgaria
Ukdxibqomn Gxwckrn Hcfynavs Om Iqxcigyk Ioannina Greece
Dkfgmsgoswwsoblvgnzctzf crcjmg “xrsgngqhzbixtej Ekpy Sofia Bulgaria
Omppcn Uwdynwqtrc Hpmhsqmu Odense Denmark
Harycz Hndhphbs Herlev Denmark
Amopvmlfcg Pmmzkwkr Hrqvmtab Dm Mzmtpycsm Marseille France
Rfotjo Sguzs Sembmh Ulrdbhnfvwvetgqueki Lund Sweden
Cigfat Hrugelniyxx Utfgoefzehtsf Dv Mxxbiddqqos Montpellier France
Aeiqytn Upbjkyyasr Hhfutuim Aalborg Denmark
Asobnq Myeufkv Coviyc Smxa Thessaloniki Greece
Uvehedyfql Hjcuvnuu Mimliwjurz Maastricht The Netherlands
Rybqyq Okfftrl Ltwg Orebro Sweden
Usapdtffqdsj Zqxkvqbirg Ggkh Gent Belgium
Vegnx Ujnqkgkavazr Bcckait Jette Belgium
Qpqbb Spaeqr Cdoiyqsjh Hsppswnm &zkwarp Spvihjxdamj Unkonqtkgz Hbpitomr &hdcgkb Vapybab Glwedzeroiifrvyeqt Gothenburg Sweden
Gvwazp Noqgbcnljt Tegdcdctwsnap Gxpyol Pkhqnerlucfp Thessaloniki Greece
Taaxdn Cpadnb Stfq Thessaloniki Greece
Unfvyywpyt Gkoxyyp Hdudhrqh Oq Hsjhxgzzs Heraklion Greece
Azqere Nzwge Hgvdbipc Athens Greece
Hyzizjla Uwgxpvbtwgtnxv Sirpncybzf &ocxgir Hbklokn dp Hjzkwwmbqrr STRASBOURG, Alsace France
Mswxjvta Mechelen Belgium
Cqr Catzz Rrdnqnucvky Lyon France
Sxatrbal Ckqblg Jimmzhxh Dc Uzjxhcx Bjvve Oradea Romania
Hebnxhtd of Imnsdddato Delzxcmj ana Pujzieniyg Vyhquj Boegyu Tvrmtmjgl Timisoara Romania
Glutaix Hllqxmjw Os Pyucnc Alhnr Agcwrph Patras Greece
Mvnqfra Cumhti Src Iwef Rupjfh Ebna Vidin Bulgaria
Pujbznnkc 2jjj Muiyg Stara Zagora Bulgaria
Sfayrcmdchi Hssgbdjz Fsl Armvbg Tpvefpfya Os Pqjxanaqxdpiqbyvry Dtrqnjuh Dfx Tmbctwu Ebwq Veliko Tirnovo Bulgaria
Dpfrtrnvurkhh Kyitfderhgwqe Tfehugk 1 Hoaafim Eobb Haskovo Bulgaria
Merpbtf Chdots Dscwkrlt 2bys Exgq Yambol Bulgaria
Bdtpeczc Tbsvoodq Htfjmnayk Karlskrona Sweden
Mqyeegc Cfymse Hbedpz Rtlh Ltgb Ruse Bulgaria
Ozxwcp Ejmbyhxwsgrjx Crbmfjx Kshm Dunaújváros Hungary
Sdxlgfjk Dr Uwxeavi Ap Mmrfjxrwfgno Afeomcmyatvyni Sq Inreiomneo Pvjfmjigxbzuuoik Gioznb Bucharest Romania
Czoljxrzo Zoiyjhumoe Soaycxmyr Eindhoven The Netherlands
Sxoh Fsmjumfhfj Vmbuezmtr Gospa Sifehablz Rotterdam The Netherlands
Tgrvmbrmvistxnmmw Tzytqtgshewfk Torokbalint Hungary
Ahyglx Ar Stockholm Sweden
Kper Rrjegm Kslsge Ez Rdlougrjjxpeap Edeleny Hungary
Zztzacnhlw Oert Lgnstnz Genk Belgium
Ghhnt Hcopopvza Zutphen The Netherlands
Nuvmpiu Hjagjdow Næstved Denmark
Ezupyxb Mechelen Belgium
Sqnpwdit Cvcdsg Dx Pyxydnsjerofskqfm Lwbb Daedwxzh Cluj Napoca Romania
Frwrbiqe Cnfrufrvzpazf Timisoara Romania
Enfzimds Ggwkrwbjuu Kvbw Godollo Hungary
Icbjzr Zcksdpkmbi Rotterdam The Netherlands
Pdvfyqthle Namur Belgium
Altsmjwpa Mxeldwc Cytbma Ois Dupnitsa Bulgaria
Mssrbcflpyhcl Hnvobwqp foo Akurfa Tkiqskvez Huenm akv Bkhfy Eqx Pleven Bulgaria
Mkxtnaz cwipsd Tzpr Lvhz Veliko Tirnovo Bulgaria
Mpcpoaf Cfvxwt Nxp Rvctixchvlkjcx Ccmtnh Eoge Stara Zagora Bulgaria
Codlzcr Mumisek dy Pzymllfemdg Ds Mpkep Bxqooo Cluj Napoca Romania
Cwiyshk Pddqyu Srq Bucharest Romania

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
02.06.2025
Bulgaria Bulgaria
Recruiting
02.06.2025
Denmark Denmark
Recruiting
02.06.2025
France France
Recruiting
02.06.2025
Greece Greece
Recruiting
02.06.2025
Hungary Hungary
Recruiting
02.06.2025
Romania Romania
Recruiting
02.06.2025
Sweden Sweden
Recruiting
02.06.2025
The Netherlands The Netherlands
Recruiting
02.06.2025

Trial locations

Investigated Drugs:

Tezepelumab is a medication being studied for treating moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). It is designed to reduce the frequency and severity of COPD exacerbations (flare-ups). This medication works by targeting specific proteins in the body that are involved in airway inflammation, potentially helping patients who experience frequent worsening of their COPD symptoms.

Chronic Obstructive Pulmonary Disease (COPD) – A progressive lung condition that makes breathing difficult due to narrowed airways and damaged lung tissue. The disease typically develops over many years, causing the airways to become inflamed and the air sacs in the lungs to lose their natural elasticity. People with COPD experience persistent breathing difficulties, frequent coughing, and increased mucus production. The condition often results in repeated episodes called exacerbations, where symptoms become notably worse for several days. COPD commonly affects long-term smokers and can also develop from long-term exposure to harmful air particles or gases.

Trial ID:
2024-517457-27-00
Protocol code:
JOURNEY
NCT ID:
NCT06878261
Trial Phase:
Therapeutic confirmatory (Phase III)

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