Skip to main content
OpenTrials
Completed

NCT Number: NCT01986582

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Sofia, 1431, Bulgaria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxymetazoline

Drug

Intranasal application

Other names: Afrin

Hydroxyl-propyl-methyl cellulose powder

Other

Intranasal application

Other names: NoAl

Placebo (lactose powder)

Other

Intranasal application

Primary outcomes

  1. Peak nasal inspiratory flow (PNIF) area under the curve (AUC) change between the placebo and active NoAl treatment on day 1

    Time frame: PNIF on Day 1, 8 and 15

Secondary outcomes

  1. Difference between the PNIF AUC D1-D8 differences between the two groups

    Time frame: PNIF on D1 and D8

  2. Differences in nasal mucociliary clearance (Saccharine test) between both groups.

    Time frame: Performed on D1, D8 and D15

  3. Visual analogue scale (VAS) for the separate rhinitis symptoms between the two groups

    Time frame: On D1, D8 and D15

  4. Change of each symptom score for congestion over 8 days

    Time frame: From D1 to D8

  5. Change of total rhinitis symptom score (TRSS) over 8 days

    Time frame: From D1 to D8

  6. 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

    Time frame: For 15 days

  7. Number and severity of adverse events

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Association Asthma, Bulgaria

Other

Collaborators

  • Nasaleze

Registry information

Official study 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

Acronym: NOPAR

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2013
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.