Allergic Rhinitis/ Rhinoconjunctivitis MedDRA version: 20.0 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10019170 Term: Hay fever System Organ Class: 10021428 - Immune system disorders MedDRA version: 20.1 Level: PT Classification code 10048908 Term: Seasonal allergy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Budesolv 10 micrograms, nasal spray
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Current Sponsor code: n.a.
Concentration unit: µg/ml
Sponsors
Marinomed Biotech AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I1. Written informed consent obtained before any trial related procedures are performed I2. Healthy male or female subjects aged 18 years or older I3. Female subjects of child-bearing potential must have a negative pregnancy test and be willing to practice appropriate contraceptive methods until the end of treatment visit I4. A documented clinically relevant allergic history of moderate to severe SAR to grass pollen for the previous two years I5. Subjects exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as total nasal symptom score (TNSS) of at least 6 (out of 12) using standard VCC grass pollen allergen mixture. Nasal symptom score is the sum of “nasal congestion”, “rhinorrhea”, “itchy nose” and “sneezing”, each of which have been scored on a categorical scale from 0 to 3. I6. Positive Skin Prick Test (SPT) response (wheal diameter at least 3 mm larger than diluent control) to grass pollen SPT solutions (standard Allergopharma) at screening or within the last 6 months prior to study start. I7. Positive serum specific IgE against recombinant major allergen components of the used grass pollen (specific CAP IgE =0.70 kU/L) at screening or within the last 6 months prior to study start. I8. Patients with a body weight of = 50kg and a body mass index within the range of 19-30kg/m2. I9. Non-smoking subjects (smoked =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: E1 Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test). E2 A clinical history of uncontrolled asthma within 3 months prior to screening. E3 Subjects with asthma requiring treatment with inhaled corticosteroids on a regular basis judged by the investigator. E4 Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross-reacting allergen within the past 3 years. E5 Ongoing treatment with any allergen-specific immunotherapy product. E6 Subjects with a current oral candidiasis infection or treatment for oral candidiasis during the last 30 days before starting the study. E7 Subjects with history of tuberculosis. E8 Subjects with any fungal/viral/bacterial respiratory or systemic infections during the last 30 days. E9 Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization. E10 Clinically relevant nasal polyps, medical history of paranasal sinus surgery and/or medical history of surgery of nasal turbinates judged by the investigator. E11 Subjects with glaucoma or a family history of glaucoma. E12 Subjects using any ophthalmic steroids during the last 30 days. E13 Subjects treated with nasal, inhaled or systemic steroids during the last 30 days. E14 History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction). E15 Any clinically relevant chronic disease judged by the investigator. E16 Systemic disease affecting the immune system judged by the investigator. E17 Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening. E18 History of allergy, hypersensitivity or intolerance to any ingredients of the IMP. E19 History of alcohol or drug abuse. E20 Being immediate family of the investigator or trial staff, defined as the investigator's/staff’s spouse, parent, child, grandparent or grandchild. E21 Subjects with previous SAR that has proven unresponsive to steroid therapy. E22 Subjects treated with leukotriene antagonists (1 month before study start), long-lasting anti-histamines, like cetirizine, fexofenandine, loratadine, desloratadine, hydroxyzine (5 to 10 days before study start), mast cell stablizier (2 weeks before study start) or nasal decongestant (3 days before study start). E23 Subjects with an acute or chronic sinusitis judged by the investigator. E24 Subjects with hypersensitivity to corticosteroids judged by the investigator. E25 Subjects with ocular herpes simplex infections. E26 Subjects with cataracts and with cataract history.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to demonstrate therapeutic equivalence/non-inferiority between Budesolv 10 and Rhinocort® aqua 64, a marketed comparator containing the same compound (budesonide), in patients suffering from grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma on day 8 of treatment.;Secondary Objective: Secondary objective of the trial is the early onset of action of Budesolv 10 compared to Rhinocort® aqua 64, determined on day one of treatment.;Primary end point(s): Total nasal symptom score;Timepoint(s) of evaluation of this end point: day 8 / 2h-6h | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Total nasal symptom score;Timepoint(s) of evaluation of this end point: day 1 / 2h-6h | — |
Countries
Austria
Contacts
Public ContactProject manager
Marinomed Biotech AG
Outcome results
None listed