NoAL (HPMC) in Combination With Oxymetazoline in Patients With Allergic Rhinitis (NOPAR)
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|ClinicalTrials.gov Identifier: NCT01986582|
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : September 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Drug: Oxymetazoline Other: Hydroxyl-propyl-methyl cellulose powder Other: Placebo (lactose powder)||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Active Comparator: Group A
One puff of oxymetazoline immediately followed by one puff of hydroxyl-propyl-methyl cellulose powder, morning & evening, for 8 days.
Other Name: Afrin
Other: Hydroxyl-propyl-methyl cellulose powder
Other Name: NoAl
Placebo Comparator: Group B
One puff of oxymetazoline immediately followed by one puff of placebo, morning & evening, for 8 days.
Other Name: Afrin
Other: Placebo (lactose powder)
- 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 ]
- Difference between the PNIF AUC D1-D8 differences between the two groups [ Time Frame: PNIF on D1 and D8 ]
- Differences in nasal mucociliary clearance (Saccharine test) between both groups. [ Time Frame: 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 ]
- Change of each symptom score for congestion over 8 days [ Time Frame: From D1 to D8 ]
- Change of total rhinitis symptom score (TRSS) over 8 days [ Time Frame: 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 ]
- Number and severity of adverse events [ Time Frame: 15 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986582
|Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma|
|Sofia, Bulgaria, 1431|
|Principal Investigator:||Todor A Popov, MD, PhD||Medical University Sofia|