Demonstration of Equivalence and Early Onset of a Novel Anti-allergic Nasal Spray Compared to Marketed Nasal Spray

Launched by MARINOMED BIOTECH AG · Nov 27, 2018

Keywords

ClinConnect Summary

This is a randomized, placebo controlled, three way cross over, double-blind, single site trial in adult subjects (18 years of age and older) who demonstrate grass specific Immunglobulin E (IgE) reactivity and have a history of grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma. In the cross-over setting three treatments, namely placebo, Budesolv 10 or Rhinocort® aqua 64 will be evaluated.

The primary objective of the trial is to demonstrate therapeutic equivalence/non-inferiority between Budesolv 10 and Rhinocort® aqua 64, a marketed comparator co...

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• A subject will be eligible for inclusion in this study only if all of the following criteria apply:
• • Written informed consent obtained before any trial related procedures are performed
• • Healthy male or female subjects aged 18 years or older
• • 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
• • A documented clinically relevant allergic history of moderate to severe SAR to grass pollen for the previous two years
• • 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.
• • 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.
• • 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.
• • Patients with a body weight of ≥ 50kg and a body mass index within the range of 19-30kg/m2.
• • Non-smoking subjects (smoked \<10 packs years in their lifetime and had not smoked in the last 6 months)
• • Asthma patients only if the asthma condition is mild or intermittent, and if those are not treated with steroids
• • Subject has a forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value (ECCS) at the screening.
• • 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.
• • Subject is able to adhere to dose and visit schedules.
• • Subject is able to read, understand and complete questionnaires and diaries.
• • Exclusion Criteria
• A subject will not be eligible for inclusion in this study if any of the following criteria apply:
• • 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).
• • A clinical history of uncontrolled asthma within 3 months prior to screening.
• • Subjects with asthma requiring treatment with inhaled corticosteroids on a regular basis judged by the investigator.
• • Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross-reacting allergen within the past 3 years.
• • Ongoing treatment with any allergen-specific immunotherapy product.
• • Subjects with a current oral candidiasis infection or treatment for oral candidiasis during the last 30 days before starting the study.
• • Subjects with history of tuberculosis.
• • Subjects with any fungal/viral/bacterial respiratory or systemic infections during the last 30 days.
• • Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization.
• • Clinically relevant nasal polyps, medical history of paranasal sinus surgery and/or medical history of surgery of nasal turbinates judged by the investigator.
• • Subjects with glaucoma or a family history of glaucoma.
• • Subjects using any ophthalmic steroids during the last 30 days.
• • Subjects treated with nasal, inhaled or systemic steroids during the last 30 days.
• • History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction).
• • Any clinically relevant chronic disease judged by the investigator.
• • Systemic disease affecting the immune system judged by the investigator.
• • Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening.
• • History of allergy, hypersensitivity or intolerance to any ingredients of the IMP.
• • History of alcohol or drug abuse.
• • Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild.
• • Subjects with previous SAR that has proven unresponsive to steroid therapy.
• • 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).
• • Subjects with an acute or chronic sinusitis judged by the investigator.
• • Subjects with hypersensitivity to corticosteroids judged by the investigator.
• • Subjects with ocular herpes simplex infections.
• • Subjects with cataracts and with cataract history.