Allergic Rhinitis | NoAL (HPMC) in Combination With Oxymetazoline in Patients With Allergic Rhinitis
Allergic Rhinitis research study
What is the primary objective of this study?
Allergic rhinitis is treated with a variety of systemic and locally applied drugs. The effectiveness of the intranasally applied formulations is diminished by the cleaning mechanisms of the nose, rhinorrhea in particular. Slowing down of the clearance of the nasal mucosa and prolonging the contact time of locally applied drugs with the nasal mucosa would improve their efficacy. One method is creating dosage forms containing mucoadhesive polymers. We have demonstrated that a mucoadhesive solution containing HPMC enhances the clinical efficacy of oxymetazoline. However, the industrial development of fixed combinations of pharmaceutical compound and mucoadhesive carrier requires substantial investments, escalating manifold if different pharmaceutical compounds have to be rendered mucoadhesive. NoAl is a cellulose derivative powder, which forms a gel layer on contact with the mucosal surface of the nose blocking the contact of the pollen grains with the nasal mucosa in seasonal allergic rhinitis. However, there is another potential benefit of applying NoAl (HPMC) along with other commercially available drugs for local treatment of rhinitis, as the formation of a gel layer can substantially delay their clearance from the nose and thus increase their effectiveness. This hypothesis needs to be substantiated clinically.
Who is eligible to participate?
Inclusion Criteria: - Male or female patients - Age ≥ 18 and ≤ 50 years - Moderately severe / severe persistent allergic rhinitis - Positive skin prick test for perennial aero-allergens - Active symptoms with prominent congestion at the time of inclusion Exclusion Criteria: - Subjects with pollen sensitization during the respective pollen season - Subjects with arterial hypertension, arrhythmia or evidence of heart ischemia - Subjects with other serious chronic comorbidities and bad therapeutic control - Subjects with nasal polyposis - Flu-like episode during the past 30 days - Subjects unable to give informed consent - Subjects with any of the contra-indications of oxymetazoline or NoAL - Pregnant or lactating women
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Hydroxyl-propyl-methyl cellulose powderIntranasal application
Other:Placebo (lactose powder)Intranasal application
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2013
Completed Date: February 2014
Phase: Phase 2
Primary Outcome: Peak nasal inspiratory flow (PNIF) area under the curve (AUC) change between the placebo and active NoAl treatment on day 1
Secondary Outcome: Difference between the PNIF AUC D1-D8 differences between the two groups
Study sponsors, principal investigator, and references
Principal Investigator: Todor A Popov, MD, PhD
Lead Sponsor: Association Asthma, Bulgaria
Tzachev CT, Mandajieva M, Minkov EH, Popov TA. Comparison of the clinical efficacy of standard and mucoadhesive-based nasal decongestants. Br J Clin Pharmacol. 2002 Jan;53(1):107-9.