The Upper Airway - Allergy Clinical Trial Center

  • contributes to the development of new investigational drugs for mankind by conducting phase 1, 2 and 3 clinical trials of high quality, and in accordance with the applicable rules and legislation.
  • consists of multiple principal investigators, sub-investigators, a study coordinator, a study nurse and a study assistant/ administrator. All team members are qualified persons and are regularly trained to conduct clinical trials, according to the Good Clinical Practice Guidelines.
  • performs academic and industry sponsored studies. To accomplish this we work together with the pharmacy, the clinical laboratory and the DRUG department of the University Hospital of Ghent, each experienced and certified partners in performing clinical trials.

For participation in a number of upcoming studies we are actively looking for volunteers.

Members

Senior Principal Investigators


Study coördinator

Research Focus

  • Allergic Rhinitis
  • Acute Rhinosinusitis
  • Chronic Rhinosinusitis
  • Nasal polyps

Techniques

Randomized double-blind & placebo-controlled trials

The Upper Airway - Allergy Clinical Trial Center coordinates and conducts clinical research activities in the field of rhinology (e.g. chronic rhinosinusitis, nasal polyps,…) and allergies (e.g. pollen, House Dust Mite, ...).

Nasal Polyp Pollen Housemite

Most of the studies performed at our department are randomized, double-blind, and placebo-controlled studies (phase 1, 2 and 3).

‘Randomized’ indicates that the study participants are assigned to a particular group by chance. ‘Double blind’ means that nor the subject, nor the researchers or the people who analyze the results know the nature of this group until the clinical trial is over. The term ‘placebo-controlled’ indicates that it is possible that the volunteer is assigned to the placebo group. A placebo is an inactive drug that looks exactly like the investigational product and is administered in the same way, but has no real medical effect. The subject could receive a particular dose of the new drug or the placebo. In this way it is ensured that the different groups are similar and that the treatment is conducted in an objective way. Volunteers in the placebo group are called ‘control’ patients. The results of this group are compared to the other groups, allowing the investigators to get more insight into the actual effects of the tested dosages.

The Upper Airway-Allergy Clinical Trial Center performs a wide variety of studies. A large part is categorized as ‘immunotherapeutic treatment’.

Immunotherapy can be defined as a treatment that battles a disease/allergy by inducing, enhancing, or suppressing an immune response. The active agents of immunotherapy are called “immunomodulators”. They are a diverse array of recombinant, synthetic and natural preparations.
In the case of chronic inflammation of the nasal mucosa (nasal polyps) often humanized antibodies against cytokines or cytokine receptors are tested (anti-IL-5, anti-IgE), which have shown their benefit. in the case of allergy, allergen extracts or recombinant allergenpeptides are used. For example, patients with an allergy are desensitized using extracts of the allergen in a low dose, thereby giving the immune system a boost and the opportunity to restore itself.

Immunotherapeutic treatment tackles the origin of the problem, and not only the symptoms. Complaints can diminish or even completely disappear, which considerably improves the quality of life.

Collaborations

The Upper Airway - Allergy Clinical Trial Center performs academic and industry sponsored studies. To accomplish this we work together with the pharmacy, the clinical laboratory and the DRUG department of the University Hospital of Ghent, each experienced and certified partners in performing clinical trials.

Our research/clinical trial team works in close collaboration with different departments of the University Hospital of Ghent, such as the department of pneumology (Prof. G. Joos and Prof. B. Lambrecht), which is working on the inflammatory processes of the lower airways. This collaboration is also important for phenotyping of the patients included in our studies. Our research group is partner in a national IUAP project called AIREWAY, which is a national approach for the study basic immunopathological mechanism that is the basis of obstructive disorders of the airways like asthma, COPD and CRS. Prof. P. Van Cauwenberghe (Rector, formerly head of the department) is head of the GA2LEN project, part of the 6th European framework program which has as goal the integration of molecular, genetical and clinical knowledge on the area of asthma and allergy. Prof C. Bachert, head of a workpackage, focuses on studies in chronic rhinosinusitis together with eight other centres of excellence in Europe. This WP coordinates research in the areas of epidemiology, phenotyping of inflammation, remodelling, gene polymorphisms and impact of bacterial products on mucosal inflammation and IgE synthesis. In addition our laboratory is involved in other European projects like PREDICTA and MEDALL, which are part of the 7th European framework programs.

The Principle investigators of our team are also involved in initiatives from the World Health Organisation (WHO) in the set-up of ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines and from initiatives of European Academy of Allergology and Clinical Immunology (EAACI) for example “EPOS” (European Position Paper on Sinusitis).


Contactafbeelding poli 1

Campus UZ Gent

1P1 (ingang 69)

De Pintelaan 185

B - 9000 Gent BELGIUM

Study Coordinator: Lara Derycke 

Phone: +32 9 332 12 46

url.clinicaltrials@ugent.be