NoAL (HPMC) in Combination With Oxymetazoline in Patients With Allergic Rhinitis

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Oxymetazoline; Other: Hydroxyl-propyl-methyl cellulose powder; Other: Placebo (lactose powder)

• Registration Number: NCT01986582
• Lead Sponsor: Association Asthma, Bulgaria

Brief Summary

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.

Detailed Description

The main objective of the trial is to test the synergy between HPMC and oxymetazoline (both applied nasally) on the increase of peak nasal inspiratory flow in patients suffering from moderately severe / severe persistent allergic rhinitis.

The design of the trial is parallel-groups, double blind, randomized, placebo controlled, single centre study.

Forty patients are randomly assigned to receive either oxymetazoline followed by HPMC (Group A) or oxymetazoline followed by placebo (Group B).

Each patient is followed up for 15 days. Day 1 is the screening and inclusion visit. Data will then be collected on day 8 \& 15. Patients will fill in diaries their everyday symptoms, adverse events and applied medications.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-18
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-21
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Hydroxyl-propyl-methyl cellulose powder	One puff of oxymetazoline immediately followed by one puff of hydroxyl-propyl-methyl cellulose powder, morning \& evening, for 8 days.
Group B	Placebo (lactose powder)	One puff of oxymetazoline immediately followed by one puff of placebo, morning \& evening, for 8 days.
Group A	Oxymetazoline	One puff of oxymetazoline immediately followed by one puff of hydroxyl-propyl-methyl cellulose powder, morning \& evening, for 8 days.
Group B	Oxymetazoline	One puff of oxymetazoline immediately followed by one puff of placebo, morning \& evening, for 8 days.

Primary Outcome Measures

Name	Time	Method
Peak nasal inspiratory flow (PNIF) area under the curve (AUC) change between the placebo and active NoAl treatment on day 1	PNIF on Day 1, 8 and 15

Secondary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS) for the separate rhinitis symptoms between the two groups	On D1, D8 and D15
Difference between the PNIF AUC D1-D8 differences between the two groups	PNIF on D1 and D8
Difference in the applied rescue decongestant (total number of additional puffs of oxymetazoline or any other medications indicated for the treatment of allergic rhinitis) as needed between the two groups	For 15 days
Differences in nasal mucociliary clearance (Saccharine test) between both groups.	Performed on D1, D8 and D15
Change of total rhinitis symptom score (TRSS) over 8 days	From D1 to D8
Number and severity of adverse events	15 days
Change of each symptom score for congestion over 8 days	From D1 to D8

Trial Locations

Locations (1)

Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma; 🇧🇬 Sofia, Bulgaria