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Clinical trial

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

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Last updated:19th Nov 2018
Identifier: NCT03755557

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.

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/Rhinoconjunctivitis With or Without Controlled Asthma
Actual Study Start Date: November 19, 2018
Estimated Primary Completion Date: April 30, 2019
Estimated Study Completion Date: April 30, 2019

- Placebo Comparator:
- Active Comparator: Rhinocort
- Experimental: Budesolv

Category Value
Date last updated at source 2019-01-23
Study type(s) Interventional
Expected enrolment 82
Study start date 2018-11-19
Estimated primary completion date 2019-04-30

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