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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
Sponsor:
Collaborator:
Nasaleze
Information provided by (Responsible Party):
Prof. Todor Popov, Association Asthma, Bulgaria

Brief 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.


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Oxymetazoline Other: Hydroxyl-propyl-methyl cellulose powder Other: Placebo (lactose powder) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 Name: Afrin

Other: Hydroxyl-propyl-methyl cellulose powder
Intranasal application
Other Name: 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 Name: Afrin

Other: Placebo (lactose powder)
Intranasal application




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Bulgaria
Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma
Sofia, Bulgaria, 1431
Sponsors and Collaborators
Association Asthma, Bulgaria
Nasaleze
Investigators
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Principal Investigator: Todor A Popov, MD, PhD Medical University Sofia
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Todor Popov, Professor, Association Asthma, Bulgaria
ClinicalTrials.gov Identifier: NCT01986582    
Other Study ID Numbers: NoAL001
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Keywords provided by Prof. Todor Popov, Association Asthma, Bulgaria:
Allergic Rhinitis
Congestion
Mucoadhesive Treatment
Nasal Decongestant
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Phenylephrine
Oxymetazoline
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Cardiotonic Agents
Mydriatics
Adrenergic alpha-1 Receptor Agonists
Protective Agents