We investigate the effects of allergen and virus on patients with recurrent tonsillitis or tonsillar hypertrphy.
Conditions
Interventions
Trade Name: Grazax
Pharmaceutical Form: Tablet
Trade Name: Fluenz
Pharmaceutical Form: Nasal spray, suspension
Trade Name: Staloral® -birch
Pharmaceutical Form: Sublingual spray, solution
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -elective tonsillectomy with or without adenotomy according to clinicl indication -age >4 and 4 and 18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -systemic anti-inflammatory medication within prior 4 weeks -systemic diseases affecting the immune system e.g. autoimmune diseases, immune complex diseases or immune deficiency diseases other than allergy, asthma or atopic dermatitis -malignancy, depression, psychiatric illness or medication; planned vaccination during the study period -forced expiratory volume in 1 second (FEV1) is under 80% of normal value or asthma is in a bad balance for those patients who would participate in the immunotherapy -sublingual grass pollen will not be given for children under the age of 5 -additional exclusion criteria for Grazax® include hypersensitivity to any of the excipients (gelatin [fish source], mannitol, sodium hydroxide), inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis, patients with uncontrolled or severe asthma (in adults: FEV1 < 70% of predicted value after adequate pharmacologic treatment, in children: FEV1 < 80% of predicted value after adequate pharmacologic treatment) -addition exclusion criteria for FluMist/Fluenz® include hypersensitivity to the active substances, to any of the excipients and children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild- type influenza infection. -Additional exclusion criteria for Staloral® -birch include hypersensitivity to any of the expicients (sodium chloride, glycerol, mannitol, purified water), serious immunodefiency, malignant diseases, unstable asthma, auto-immune diseases, oral inflammation or bleeding, or ongoing treatment with beta-blockers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effects of sublingual grass pollen immunotherapy, sublingual birch immunotherapy and/or nasal live attenuated influenza vaccine on tonsillar T cell and interferon expressions and related immunogenetics.;Secondary Objective: Control group in combination with the intervention group and our previous tonsil cohort will also be used for investigation of role of tissues in immune tolerance and chronicity in allergic diseases, immunomodulatory effects of respiratory viruses main focus being on human bocavirus and human rhinovirus infections, and in the search of new respiratory viruses.;Primary end point(s): Primary end point is the tonsillectomy. After that the trial is over for that particular patient.;Timepoint(s) of evaluation of this end point: There's no need for a timepoint of evaluation of the end point because the trial will end in all cases to the tonsillectomy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None.;Timepoint(s) of evaluation of this end point: None. | — |
Countries
Finland
Contacts
Public ContactTurku University Hospital
Turku University Hospital
Outcome results
None listed