Demonstration of equivalent effectiveness of a novel anti-allergic nasal spray and a marketed nasal product as well as demonstration of fast symptom reduction in allergic patients.

Phase 1

• Conditions: Allergic Rhinitis/ Rhinoconjunctivitis; MedDRA version: 20.0Level: PTClassification code 10039085Term: Rhinitis allergicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 20.0Level: LLTClassification code 10019170Term: Hay feverSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.1Level: PTClassification code 10048908Term: Seasonal allergySystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-001324-19-AT
• Lead Sponsor: Marinomed Biotech AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-14
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

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 <10 packs years in their lifetime and had not smoked in the last 6 months)
I10.Asthma patients only if the asthma condition is mild or intermittent, and if those are not treated with steroids
I11.Subject has a forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value (ECCS) at the screening.
I12.Subject is capable of understanding the study procedures and potential risks associated with the study, and voluntarily agrees to participate by giving written informed consent.
I13.Subject is able to adhere to dose and visit schedules.
I14.Subject is able to read, understand and complete questionnaires and diaries.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

E1Pregnant, 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).
E2A clinical history of uncontrolled asthma within 3 months prior to screening.
E3Subjects with asthma requiring treatment with inhaled corticosteroids on a regular basis judged by the investigator.
E4Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross-reacting allergen within the past 3 years.
E5Ongoing treatment with any allergen-specific immunotherapy product.
E6Subjects with a current oral candidiasis infection or treatment for oral candidiasis during the last 30 days before starting the study.
E7Subjects with history of tuberculosis.
E8Subjects with any fungal/viral/bacterial respiratory or systemic infections during the last 30 days.
E9Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization.
E10Clinically relevant nasal polyps, medical history of paranasal sinus surgery and/or medical history of surgery of nasal turbinates judged by the investigator.
E11Subjects with glaucoma or a family history of glaucoma.
E12Subjects using any ophthalmic steroids during the last 30 days.
E13Subjects treated with nasal, inhaled or systemic steroids during the last 30 days.
E14History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction).
E15Any clinically relevant chronic disease judged by the investigator.
E16Systemic disease affecting the immune system judged by the investigator.
E17Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening.
E18History of allergy, hypersensitivity or intolerance to any ingredients of the IMP.
E19History of alcohol or drug abuse.
E20Being immediate family of the investigator or trial staff, defined as the investigator's/staff’s spouse, parent, child, grandparent or grandchild.
E21Subjects with previous SAR that has proven unresponsive to steroid therapy.
E22Subjects 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).
E23Subjects with an acute or chronic sinusitis judged by the investigator.
E24Subjects with hypersensitivity to corticosteroids judged by the investigator.
E25Subjects with ocular herpes simplex infections.
E26Subjects with cataracts and with cataract history.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Total nasal symptom score;Timepoint(s) of evaluation of this end point: day 1 / 2h-6h