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

September 21, 2015 updated by: Prof. Todor Popov, Association Asthma, Bulgaria

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1431
        • Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
PNIF on Day 1, 8 and 15

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Asthma, Bulgaria

Collaborators

Nasaleze

Investigators

  • Principal Investigator: Todor A Popov, MD, PhD, Medical University Sofia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

November 12, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NoAL001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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