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

Sponsor

Association Asthma, Bulgaria (Other)

Overall Status

Completed

CT.gov ID

NCT01986582

Collaborator

Nasaleze (Industry)

Enrollment

Location

Arms

Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: Oxymetazoline Other: Hydroxyl-propyl-methyl cellulose powder Other: Placebo (lactose powder)	Phase 2

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Stage 2, Double-blind, Randomized, Parallel Groups, One Centre Study in Patients With Allergic Rhinitis Treated With Nasal Oxymetazoline in Combination With Nasal Hydroxyl-propyl-methyl Cellulose (HPMC) or Placebo

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A One puff of oxymetazoline immediately followed by one puff of hydroxyl-propyl-methyl cellulose powder, morning & evening, for 8 days.	Drug: Oxymetazoline Intranasal application Other Names: Afrin Other: Hydroxyl-propyl-methyl cellulose powder Intranasal application Other Names: NoAl
Placebo Comparator: Group B One puff of oxymetazoline immediately followed by one puff of placebo, morning & evening, for 8 days.	Drug: Oxymetazoline Intranasal application Other Names: Afrin Other: Placebo (lactose powder) Intranasal application

Arm

Intervention/Treatment

Active Comparator: Group A

One puff of oxymetazoline immediately followed by one puff of hydroxyl-propyl-methyl cellulose powder, morning & evening, for 8 days.

Drug: Oxymetazoline

Intranasal application

Other Names:

Afrin

Other: Hydroxyl-propyl-methyl cellulose powder

Intranasal application

Other Names:

NoAl

Placebo Comparator: Group B

One puff of oxymetazoline immediately followed by one puff of placebo, morning & evening, for 8 days.

Drug: Oxymetazoline

Intranasal application

Other Names:

Afrin

Other: Placebo (lactose powder)

Intranasal application

Outcome Measures

Primary Outcome Measures

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

Difference between the PNIF AUC D1-D8 differences between the two groups [PNIF on D1 and D8]
Differences in nasal mucociliary clearance (Saccharine test) between both groups. [Performed on D1, D8 and D15]
Visual analogue scale (VAS) for the separate rhinitis symptoms between the two groups [On D1, D8 and D15]
Change of each symptom score for congestion over 8 days [From D1 to D8]
Change of total rhinitis symptom score (TRSS) over 8 days [From D1 to 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]
Number and severity of adverse events [15 days]