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

NCT ID: NCT01986582

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-02-28

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Oxymetazoline

Intervention Type: DRUG

Intranasal application

Hydroxyl-propyl-methyl cellulose powder

Intervention Type: OTHER

Intranasal application

Group B

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

Group Type: PLACEBO_COMPARATOR

Oxymetazoline

Intervention Type: DRUG

Intranasal application

Placebo (lactose powder)

Intervention Type: OTHER

Intranasal application

Interventions

Oxymetazoline

Intranasal application

Intervention Type: DRUG

Hydroxyl-propyl-methyl cellulose powder

Intranasal application

Intervention Type: OTHER

Placebo (lactose powder)

Intranasal application

Intervention Type: OTHER

Other Intervention Names

Afrin; NoAl

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nasaleze

INDUSTRY

Sponsor Role: collaborator

Association Asthma, Bulgaria

OTHER

Sponsor Role: lead

Responsible Party

Prof. Todor Popov

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Todor A Popov, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University Sofia

Locations

Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma

Sofia, , Bulgaria

Countries

Bulgaria

References

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. doi: 10.1046/j.0306-5251.2001.01525.x.

Reference Type: BACKGROUND

PMID: 11849202 (View on PubMed)

Valerieva A, Popov TA, Staevska M, Kralimarkova T, Petkova E, Valerieva E, Mustakov T, Lazarova T, Dimitrov V, Church MK. Effect of micronized cellulose powder on the efficacy of topical oxymetazoline in allergic rhinitis. Allergy Asthma Proc. 2015 Nov-Dec;36(6):e134-9. doi: 10.2500/aap.2015.36.3879. Epub 2015 Jun 29.

Reference Type: DERIVED

PMID: 26133030 (View on PubMed)

Other Identifiers

NoAL001

Identifier Type: -

Identifier Source: org_study_id