Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03097432
Other study ID # Oralvac Compact Bäume
Secondary ID
Status Completed
Phase N/A
First received March 17, 2017
Last updated October 24, 2017
Start date October 20, 2016
Est. completion date October 19, 2017

Study information

Verified date October 2017
Source University Hospital of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective open multi-centre non-interventional study initiated to document the up-dosing period of children and adults with allergic rhinoconjunctivitis and/or allergic asthma treated with a SLIT containing purified, aqueous extracts of birch, alder, and hazel pollen. The following up-dosing schemes are freely selectable: scheme A consists of an up-dosing period of 12 days at the patient´s home using the standardized pollen extract in three different solution strengths to reach the maximum dose; scheme B is performed only with the highest solution strength at the physician's office within 2 hours; and the new scheme C which is a regimen for initiation at the physician`s office and continuation at the patient`s home also exclusively using the highest solution strength and takes 4 days. Data are documented by physicians and in patients´ diaries.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date October 19, 2017
Est. primary completion date October 19, 2017
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria:

- Patients of the age of 2 years and older suffering from a tree pollen induced seasonal allergic rhinitis

Exclusion Criteria:

- Patients suffering from acute or chronic infections or inflammations

- Patients suffering from secondary modifications of the target organ with function impairment (emphysema, bronchiectasis)

- Patients suffering from severe and uncontrolled asthma

- Patients with a known severe autoimmune disease

- Patients with active malignant disease

- Patients requiring beta-blockers

- Patients having any contraindication for the use of adrenaline

- Patients with a hypersensitivity to the excipients of the drug

Study Design


Intervention

Drug:
ORALVAC COMPACT BÄUME


Locations

Country Name City State
Germany UHCologne Cologne

Sponsors (2)

Lead Sponsor Collaborator
University Hospital of Cologne Bencard Allergie GmbH, Munich, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events (Safety and Tolerability) Tolerability and safety will be assessed by the frequency and intensity of local reactions (mouth, lips, pharynx/throat, gastrointestinal tract) and systemic reactions (skin, airways, others) during the up-dosing phase. up to 12 days of the up-dosing phase
Primary Improvement of rhinoconjunctivitis symptoms and intake of rescue medication (efficacy) Efficacy will be assessed by the improvement of rhinoconjunctivitis symptoms and intake of rescue medication during the tree pollen season 2017 through study completion, tree pollen season 2017
Secondary Evaluation of tolerability and safety Tolerability and safety of the treatment with ORALVAC COMPACT BĂ„UME will be evaluated by the frequency and intensity of miscellaneous adverse events during the up-dosing phase. up to 12 days of the up-dosing phase
See also
  Status Clinical Trial Phase
Terminated NCT01337323 - Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns Among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting N/A
Completed NCT01171664 - Clinical Trial of STAHIST in Seasonal Allergic Rhinitis (SAR) Subjects Phase 2
Completed NCT00784732 - A Study to Compare the Efficacy of QAV680 Against Placebo in Treating Seasonal Allergic Rhinitis in an Environmental Exposure Chamber Phase 2
Completed NCT00619827 - Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract Phase 1
Completed NCT00578929 - Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients Phase 3
Completed NCT00209365 - The Role of Pollen Starch Granules in Pollen Challenge Studies in the Fraunhofer Environmental Exposure Unit N/A
Terminated NCT00223587 - Seasonal Allergic Rhinitis and Driving Ability Phase 4
Completed NCT00637455 - Single Center, Randomized, Double-Blind,Crossover Study Comparing Effects Of Single-Dose Fexofenadine HCl 180 mg, Cetirizine 10 mg, and Placebo on Cognitive Performance in Naval Flight Personnel Phase 4
Completed NCT00963599 - Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117) Phase 3
Recruiting NCT05346718 - Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis N/A
Completed NCT06126952 - Azelastine Allergen Chamber - Onset of Action Study Phase 2
Completed NCT01940146 - Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis Phase 2
Completed NCT02245360 - Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis Phase 3
Completed NCT01230619 - Vienna Challenge Chamber Study Using RV658 in Subjects With Allergic Rhinitis Phase 2
Completed NCT00561717 - A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis Phase 4
Completed NCT00574210 - PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm) Phase 2
Completed NCT00420082 - A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Phase 2
Completed NCT00443495 - Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis Phase 1/Phase 2
Completed NCT00405899 - Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections N/A
Completed NCT05540717 - Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen Phase 3