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

NCT01986582 | Completed Phase 2 DMC

• 1 other identifier: NoAL001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis; Congestion; Mucoadhesive Treatment; Nasal Decongestant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Oxymetazoline; Other: Hydroxyl-propyl-methyl cellulose powder

Group B

PLACEBO COMPARATOR

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

Drug: Oxymetazoline; Other: Placebo (lactose powder)

Interventions

Oxymetazoline DRUG

Intranasal application

Also known as: Afrin

Group A; Group B

Hydroxyl-propyl-methyl cellulose powder OTHER

Intranasal application

Also known as: NoAl

Group A

Placebo (lactose powder) OTHER

Intranasal application

Group B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patients
• Age ≥ 18 and ≤ 50 years
• Moderately severe / severe persistent allergic rhinitis
• Positive skin prick test for perennial aero-allergens

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Asthma, Bulgaria: lead
• Nasaleze: collaborator

Study Sites (1)

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

Sofia, 1431, Bulgaria

Location

Related Publications (2)

• 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.

  PMID: 11849202 BACKGROUND

• 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.

  PMID: 26133030 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Oxymetazoline

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Todor A Popov, MD, PhD

  Medical University Sofia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 18, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

BU (1)