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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03755557
Recruitment Status : Completed
First Posted : November 28, 2018
Last Update Posted : October 12, 2020
Information provided by (Responsible Party):
Marinomed Biotech AG

Brief Summary:

Intranasal corticosteroids are accepted as safe and effective first-line therapy for allergic rhinitis, especially in treatment of persistent symptoms.

Budesonide, a non-halogenic glucocorticoid, is widely used in the management of inflammatory mucosal diseases like chronic obstructive pulmonary disease, asthma and allergic rhinitis. It is a highly fat-soluble substance with low water solubility and is presented as dispersion in marketed nasal sprays, like Rhinocort aqua 64. The maximum therapeutic efficacy of Rhinocort aqua is obtained after an application period of 7 to 14 days. In Budesolv, the solubility of budesonide is considerably increased suggesting that the same therapeutic efficacy can be reached with a lower dose. Better bioavailability of the dissolved drug promise an earlier onset of therapeutic efficacy. The current trial is undertaken to demonstrate these two effects. Subjects suffering from grass pollen allergic rhinitis will be challenged with grass pollen in a challenge chamber.

Allergic subjects will be treated with two actuations (50 μl) of respective study treatment into each nostril once daily for 8 days. The total daily budesonide dose will be 40 μg per subject for Budesolv 10 and 256 μg per subject for Rhinocort® aqua 64. The primary objective of the study is to show non-inferiority of Budesolv 10 to Rhinocort® aqua 64. On day 8 grass pollen allergic patients will be challenged with grass pollen over a period of 6 hours and subjective nasal symptoms (congestion, sneezing, itching, rhinorrhea) as well as objective symptoms (nasal airflow, nasal secretion) will be assessed every 15 minutes.

The second objective of the trial is to demonstrate an early on-set of therapeutic efficacy of Budesolv 10 compared to Rhinocort aqua. On day 1, grass pollen allergic patients will be challenged with grass pollen allergen in the challenge chamber over a period of 6 hours. After 1 hour 45 minutes, patients will receive their first dosage of the respective nasal spray treatment. During the 6 hour grass pollen challenge, subjective and objective endpoints will be measured every 15 minutes.

To eliminate an individual bias based on expectations, the effect and onset of action is also compared to the effects of a suitable placebo. The same set of study participants will receive all three interventions in three consecutive treatment periods.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Allergic Conjunctivitis Hayfever Drug: Rhinocort Drug: Budesolv Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 3-way crossover, randomized, prospective, placebo-controlled, double blinded study in a validated allergen exposure chamber setting using grass pollen allergen
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The visual aspects of the three treatment arms are identical. Identification of the treatment is achieved via a randomization code.
Primary Purpose: Treatment
Official Title: Demonstration of Therapeutic Equivalence/Non-inferiority as Well as Early Onset of Action of the Novel Water-soluble Budesonide Nasal Spray (Budesolv 10) Compared With Marketed Rhinocort® Aqua 64 in Patients Suffering From Grass Pollen Induced Allergic Rhinitis
Actual Study Start Date : November 19, 2018
Actual Primary Completion Date : April 5, 2019
Actual Study Completion Date : April 5, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Budesonide

Arm Intervention/treatment
Placebo Comparator: Placebo
Application of a placebo nasal spray once daily for 8 days Nasal Sprays
Other: Placebo
Application of a nasal spray
Other Name: buffered saline

Active Comparator: Rhinocort
Nasal Sprays Application of "Rhinocort Aqua 64 micrograms, nasal spray" once daily for 8 days. Daily dosage 256 µg/d
Drug: Rhinocort
Application of a nasal spray
Other Name: Budesonide

Experimental: Budesolv
Application of a Budesolv 10 micrograms, nasal spray once daily for 8 days. Daily dosage 40 µg/d Nasal Sprays
Drug: Budesolv
Application of a nasal spray
Other Name: Budesonide

Primary Outcome Measures :
  1. Total Nasal Symptom Score [ Time Frame: 2 - 6 hours of allergen challenge ]
    subjective compound score evaluating "nasal congestion", "rhinorrhea", "itchy nose" and "sneezing" from "0" (absent) to "3" (severe). The sum of sub-scores is reported as total nasal symptom score (0 - 12)

Secondary Outcome Measures :
  1. Total Ocular Symptom Score [ Time Frame: 2 - 6 hours of allergen challenge ]
    subjective compound score evaluating "ocular itching", "redness", "watery eyes" from "0" (absent) to "3" (severe). The sum of sub-scores is reported as total ocular symptom score (0 - 9)

  2. Total Asthma Symptom Score [ Time Frame: 2 - 6 hours of allergen challenge ]
    subjective compound score evaluating "cough", "wheeze", "dyspnea" from "0" (absent) to "3" (severe). The sum of sub-scores is reported as total asthma symptom score (0 - 9)

  3. Nasal airflow [ Time Frame: 0 - 6 hours of allergen challenge ]

  4. Nasal secretion [ Time Frame: 0 - 6 hours of allergen challenge ]
    tissue weight

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03755557

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Vienna Challenge Chamber
Vienna, Austria, 1140
Sponsors and Collaborators
Marinomed Biotech AG
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Study Chair: Eva E Prieschl-Grassauer, PhD Marinomed Biotech AG
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Responsible Party: Marinomed Biotech AG Identifier: NCT03755557    
Other Study ID Numbers: BDS_18_01
2018-001324-19 ( EudraCT Number )
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marinomed Biotech AG:
allergic rhinitis
allergic rhinoconjuntivitis
allergen exposure chamber
onset of action
therapeutic equivalence
total nasal symptom score
nasal congestion
Vienna Challenge Chamber
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Respiratory Tract Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists