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

Allergic Rhinitis Clinical Trial

— NOPAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986582
• Other study ID #: NoAL001
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2013
• Last updated: September 21, 2015
• Start date: October 2013
• Est. completion date: February 2014

Study information

• Verified date: September 2015
• Source: Association Asthma, Bulgaria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Ethics committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• Oxymetazoline
Intranasal application

Other:
• Hydroxyl-propyl-methyl cellulose powder
Intranasal application
• Placebo (lactose powder)
Intranasal application

Locations

Country	Name	City	State
Bulgaria	Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma	Sofia

Sponsors (2)

Lead Sponsor	Collaborator
Association Asthma, Bulgaria	Nasaleze

Country where clinical trial is conducted

Bulgaria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Difference between the PNIF AUC D1-D8 differences between the two groups		PNIF on D1 and D8	No
Secondary	Differences in nasal mucociliary clearance (Saccharine test) between both groups.		Performed on D1, D8 and D15	No
Secondary	Visual analogue scale (VAS) for the separate rhinitis symptoms between the two groups		On D1, D8 and D15	No
Secondary	Change of each symptom score for congestion over 8 days		From D1 to D8	No
Secondary	Change of total rhinitis symptom score (TRSS) over 8 days		From D1 to D8	No
Secondary	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	No
Secondary	Number and severity of adverse events		15 days	Yes