Study on the Effectiveness of PURETHAL Mites for Adults with Moderate to Severe Allergic Rhinitis or Rhinoconjunctivitis Due to House Dust Mite Allergy

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for people with allergic rhinitis or rhinoconjunctivitis, which are conditions that cause symptoms like sneezing, runny nose, and itchy eyes. These symptoms are triggered by an allergy to house dust mites. Some participants may also have asthma, a condition that affects breathing. The treatment being tested is called PURETHAL Mites 50,000 AUeq/mL, which is a type of subcutaneous immunotherapy. This means it is given as an injection under the skin to help the body build up a tolerance to the allergens from house dust mites.

The purpose of the study is to see how effective this treatment is in reducing the symptoms of allergic rhinitis and rhinoconjunctivitis over a period of one year. Participants will receive either the PURETHAL treatment or a placebo. The study will involve regular visits to the clinic for injections and assessments. Participants will be asked to keep a daily diary of their symptoms and any changes they notice. The study will also monitor the safety of the treatment and any side effects that may occur.

In addition to the main treatment, the study will use various tests to assess the participants’ allergic reactions. These include skin-prick tests with substances like dog epithelia, cat epithelia, and mugwort pollen extract, as well as nasal sprays and eye drops containing substances like loratadine and azelastine. These tests help to understand how the body reacts to different allergens and to measure the effectiveness of the treatment. The study aims to provide valuable information on managing allergic conditions caused by house dust mites.

1 initial visit

Upon joining the study, you will attend an initial visit where you will receive detailed information about the trial. You will be asked to sign an informed consent form, confirming your understanding and willingness to participate.

During this visit, a series of tests will be conducted to confirm your eligibility. These tests include a skin-prick test to check for allergies to house dust mites, and a nasal provocation test to assess your reaction to specific allergens.

2 baseline assessment

You will be required to complete a daily electronic diary for two weeks. This diary will record your symptoms and any medication you take. It is important to maintain at least 70% compliance with diary entries to ensure accurate baseline data.

3 treatment phase

The treatment phase involves receiving subcutaneous injections of PURETHAL Mites 50,000 AUeq/mL. These injections are administered under the skin and are designed to help your body build tolerance to house dust mites.

The dosage is 0.5 mL per injection, and the treatment will continue for approximately one year. The frequency of injections will be determined by the study protocol and communicated to you by the study team.

4 monitoring and follow-up

Throughout the treatment phase, you will have regular follow-up visits to monitor your progress and any side effects. These visits will include assessments of your symptoms and overall health.

You will continue to complete the electronic diary during specific periods, including one week after the seventh maintenance visit and for eight weeks at the end of the treatment.

5 final assessment

At the end of the treatment period, a final assessment will be conducted. This will include a review of your symptom scores, lung function tests, and any changes in your allergy-related blood markers.

The study team will evaluate the effectiveness of the treatment based on the data collected throughout the trial.

Who Can Join the Study?

Before starting, you must sign a form called the Informed Consent Form (ICF) to show you agree to participate.
You need to have a daily Total Nasal Symptom Score (TNSS) of at least 8 out of 12 points at the beginning, based on entries in an electronic diary over 2 weeks. You should fill out the diary at least 70% of the time.
If you are a woman who can have children, you must have a negative pregnancy test at the start.
Women who can have children must use two effective methods of birth control and agree to continue using them during the study.
You must be between 18 and 65 years old when you sign the consent form.
You should have a history of moderate to severe House Dust Mite (HDM) allergic rhinitis (with or without asthma) for at least one year before starting the study.
You must be willing and able to fill out daily electronic diaries for 4 weeks during the screening period, 1 week after a specific visit, and for 8 weeks at the end of the treatment.
Your Forced Expiratory Volume in 1 second (FEV1), a measure of lung function, should be more than 70% at the start.
If you have asthma, it must be controlled throughout the study. This means using only certain medications as needed.
You must have a positive Skin Prick Test (SPT) for specific dust mites, which means a reaction of a certain size on your skin when tested.
You must have a positive Nasal Provocation Test (NPT) for a specific dust mite extract, which means a certain reaction in your nose when tested.
Your blood test must show a specific level of IgE antibodies for certain dust mites, which indicates an allergy.

Who Cannot Join the Study?

Patients with any other significant health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a known allergy to the study medication or its ingredients.
Patients who are unable to comply with the study procedures.
Patients with a history of severe reactions to allergy shots.
Patients who are currently using medications that could interfere with the study results.
Patients with uncontrolled asthma, meaning their asthma symptoms are not well-managed.
Patients with a history of drug or alcohol abuse.
Patients with any condition that, in the opinion of the study doctor, makes them unsuitable for the study.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
Provita Sp. z o.o.	Katowice	Poland
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany
Ordensklinikum Linz GmbH	Linz	Austria
Santa Sp. z o.o.	Lodz	Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.	Cracow	Poland
Praxis für HNO und Allergologie Dr. Yury Yarin	Dresden	Germany
Diagnostics And Consultation Center Convex Ltd.	Sofia	Bulgaria
Diagnostic Consultative Centre Ascendent OOD	Sofia	Bulgaria
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp. z o.o.	Tarnow	Poland
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ	Lodz	Poland
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania
FutureMeds GmbH	Berlin	Germany
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Medizentrum Essen Borbeck	Essen	Germany
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.	Poznan	Poland
HNO Praxis Dresden Dr. med. Udo Schäfer	Dresden	Germany

Other Sites

Site Name	City	Country
Alergologia Plus Sp. z o.o.	Poznan	Poland
Klinische Forschung Osnabrueck	Osnabrück	Germany
IRMED Irena Wojciechowska	Warsaw	Poland
Studienzentrum Dr. Laßmann	Saalfeld	Germany
HNO Praxis Dr. Sonja Runge	Neuenhagen	Germany
Pneumologisches Forschungsinstitut Hohegeest GbR	Geesthacht	Germany
ALL-MED Specialistyczna Opieka Medyczna. Medyczny Instytut Badawczy	Wroclaw	Poland
Pratia S.A.	Skorzewo	Poland
Medical Center Teodora EOOD	Ruse	Bulgaria
Centrum Diagnostyczno Terapeutyczne Medicus Sp. z o.o.	Lubin	Poland
Igkufzks Utk	Kaunas	Lithuania
Hmq Piibat Dbmegyrb	Dreieich	Germany
Hen Pjlxgb Dyx Tqkgzq	Duisburg	Germany
Eyr Nkzdxbkoiosi Sig z onul	Warsaw	Poland
Bkunnwzkibnyj Fcsmazui Woxugru	Neu-Isenburg	Germany
Imtblaerevci Sfrepaasmfhenlg Pohfvxuj Loployvx Efdyoime Mprwcx	Gryfice	Poland
Sisszevlvfhofsd Pygmmrhw Lrmjnfbr Axxfnyiyyb Tgfcqp Pdhrlibxpr	Bialystok	Poland
Iziqulifccdi Shjelkqamtnqjrf Pgalrbni Llakvvwt Jgl Zpcqljdsh Selnpazvvzl Aiamwbjjp	Koszalin	Poland
Ghekfej Ljypmfog Brdsff Kueivulddpwqg Pxhdvegv Acbaoeesvivhdb	Tomaszow Mazowiecki	Poland
Pubjkpiirq Ctarxri Bnavp Pzfppbcfaron I Leclrzxq Slb z oarb	Warsaw	Poland
Skpeehrhheyglev Pjdfhsly Lhdtqhgc Dzu ny mnqa Jratjo Oxjbshwrqqfaxbw	Katowice	Poland
Iyjloiyowwcv Shbzitbjfsnolvf Pumoswge Lxbiaxct Euxungyf Mfgeczzhyeyxgemsjlmi	Koszalin	Poland
Aktctlvpr Sdsfzeenp Ddeukldwvpyo If Giyehv Cnsmkoc Uev	Vilnius	Lithuania
Vlmzem kufnpjj Usx	Vilnius	Lithuania
Avmqtav Gnxdy Pgcbpaikqgf Sxpzgwxbgf	Schorndorf	Germany
Sdoxunxoffneku Dyc mnow Scolituhq	Peine	Germany
Kohhbxaa Sozoiorstu Ksmfbb fts Dodgsouyasko awd Arspumtumgzvk Ayzgeepqbmslmnnzpo Atgngptl 3	Stuttgart	Germany
Fcwjyslo fei Hpchbrivcuqcsymnidtrftglkl Azfcrcirpfro aydkyuyyq uh snmzuwpbml Oqeuvvlpwbn	Mittweida	Germany
Nkvy Hlpck Mknuklt	Bialystok	Poland
Ceypiejnmh Rmvnczdg san z ouin	Skierniewice	Poland
Mwquniz Cajzen Sprvqwg Cfjmmzhw Rbjdallf Ojx	Smolyan	Bulgaria
Huvnolgtlu Aiuk Pfaj	Goettingen	Germany
Ezu Ltvvok	Lublin	Poland
Azwlnevh &bmtinp uwy Aypocb Sfuanmmysebieo	Bonn	Germany
Cjqwomb Muztfmgi Kepgik Rslctd Bkudemgaeekhdx I Exe Kmncutgwej Slx jm	Bydgoszcz	Poland
Ir Cikzsc Szl z odaf	Lodz	Poland
Pjg Zujfyvr Sjrb	Kielce	Poland
Nyhtstbirzmu Ssngxfgldkbfeqx Zfhakl Omvyrw Zmpgafvclf Ppsvphep Ajsf Bgzuhe Apyfewubb Mmiobljx Sad jb	Skarzysko-Kamienna	Poland
Chesptj Vphbb Sre z owtb	Gdansk	Poland
Cdqfnsv Afglpeiqydo Spg z ohtm	Poznan	Poland
Scpxqn Gzcdbprep Uvl	Vilnius	Lithuania
Mzfxtnlntkj Cbllofb Apkzzwzejgi Sib z ocuq	Cracow	Poland
Cyshvvv Apyxntdhmvc Spq z orqc	Lublin	Poland
Iknbvvlvwfc aoahqhrlxmntl cxtupsx Uef	Vilnius	Lithuania
Nwqxedbuegrn Zvfytf Ognhob Zsfpdlauqg Cxoxnuq Uifro Mmabkzrrug Ptqmglwc Ssv z ohpk	Wroclaw	Poland
Mloatixebrm sxsxswupff Aqljhlila Suqqznd Igzkovgdmgpt Um Abexyiszhk Chhlpo Sbd	Riga	Latvia
Lzy Kgwgtju	Riga	Latvia
Cxk kqguaoj Uor	Kaunas	Lithuania
Aihlopgbob sewou Sijnuxevbmpfwzv Cbshjpi Mvtalcsp Aixahyv Enjsyqa Mnemevzkoi Bqztaksaiduigtzzg	Lublin	Poland
Pwqqwfuo Pwcanwrq Lparvoui Gcbsjko Pomjhynfrqjylvxnkrmxpoursns Arvl Phvmpvcnl	Bialystok	Poland
Hvc rbrafhwz Gebd	Itzehoe	Germany

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.09.2024
Bulgaria	Not recruiting	01.09.2024
Germany	Not recruiting	01.09.2024
Latvia	Not recruiting	01.09.2024
Lithuania	Not recruiting	01.09.2024
Poland	Not recruiting	01.09.2024

Trial locations

Investigated Drugs:

PURETHAL Mites Mixture is a type of treatment known as subcutaneous immunotherapy. It is designed to help people who have allergies caused by house dust mites. This therapy works by gradually exposing the body to small amounts of the allergen, which in this case is a mixture of proteins from dust mites. Over time, this can help the immune system become less sensitive to the allergen, reducing symptoms like sneezing, runny nose, and itchy eyes. This treatment is given as an injection under the skin and is intended for people with moderate to severe allergic reactions, with or without asthma, due to dust mites.

Investigated Diseases:

Allergic Rhinitis – Allergic rhinitis is an inflammation of the nasal passages caused by an allergic reaction to airborne substances, such as pollen, dust mites, or pet dander. It is characterized by symptoms such as sneezing, nasal congestion, runny nose, and itching of the nose, eyes, or roof of the mouth. The condition can be seasonal, occurring at certain times of the year, or perennial, occurring year-round. Over time, exposure to allergens can lead to persistent symptoms and may affect sleep and daily activities. The inflammation can also extend to the eyes, causing allergic conjunctivitis, which results in red, itchy, and watery eyes. Chronic exposure to allergens may also contribute to the development of asthma or exacerbate existing asthma symptoms.

Trial ID:

2023-504942-75-01

Protocol code:

PM/0059

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of PURETHAL Mites for Adults with Moderate to Severe Allergic Rhinitis or Rhinoconjunctivitis Due to House Dust Mite Allergy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?