Demonstration of Equivalence and Early Onset of a Novel Anti-allergic Nasal Spray Compared to Marketed Nasal Spray
Status:
Completed
Trial end date:
2019-04-05
Target enrollment:
Participant gender:
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.