A Phase 2 interventional study of Oxymetazoline and Hydroxyl-propyl-methyl cellulose powder in Allergic Rhinitis, sponsored by Association Asthma, Bulgaria. Completed at 1 site in Bulgaria. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-09-23.
Sponsored by Association Asthma, Bulgaria · Phase 2, Interventional, and Treatment
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.
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.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's planned enrollment of 40 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Association Asthma, Bulgaria is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
One puff of oxymetazoline immediately followed by one puff of placebo, morning \& evening, for 8 days.
Drug: Oxymetazoline · Other: Placebo (lactose powder)
Intranasal application
Also known as: Afrin
Intranasal application
Also known as: NoAl
Intranasal application
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
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Association Asthma, Bulgaria