Allergic RhinitisPhase 2NOPARNCT01986582
NoAL (HPMC) in Combination With Oxymetazoline in Patients With Allergic Rhinitis
A Phase 2 study testing Oxymetazoline and Hydroxyl-propyl-methyl cellulose powder in people with Allergic Rhinitis, run by Association Asthma, Bulgaria at 1 site in Bulgaria.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Oxymetazoline and Hydroxyl-propyl-methyl cellulose powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBulgaria
- Study dates
- Oct 2013to Feb 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma
Sofia, 1431
About this study
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
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.
Read the 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Oxymetazoline, Hydroxyl-propyl-methyl cellulose powder, Placebo (lactose powder)
- Keywords
- Allergic Rhinitis, Congestion, Mucoadhesive Treatment, Nasal Decongestant
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxymetazolineDrug
Also called Afrin
Intranasal application
Hydroxyl-propyl-methyl cellulose powderOther
Also called NoAl
Intranasal application
Placebo (lactose powder)Other
Intranasal application
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | One puff of oxymetazoline immediately followed by one puff of hydroxyl-propyl-methyl cellulose powder, morning \& evening, for 8 days. Receives: Drug: Oxymetazoline; Other: Hydroxyl-propyl-methyl cellulose powder |
| Group B | Placebo comparator | One puff of oxymetazoline immediately followed by one puff of placebo, morning \& evening, for 8 days. Receives: Drug: Oxymetazoline; Other: Placebo (lactose powder) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak nasal inspiratory flow (PNIF) area under the curve (AUC) change between the placebo and active NoAl treatment on day 1
Measured: PNIF on Day 1, 8 and 15
Secondary outcomes (7)
Difference between the PNIF AUC D1-D8 differences between the two groups
Measured: PNIF on D1 and D8
Differences in nasal mucociliary clearance (Saccharine test) between both groups.
Measured: Performed on D1, D8 and D15
Visual analogue scale (VAS) for the separate rhinitis symptoms between the two groups
Measured: On D1, D8 and D15
Change of each symptom score for congestion over 8 days
Measured: From D1 to D8
Change of total rhinitis symptom score (TRSS) over 8 days
Measured: 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
Measured: For 15 days
Number and severity of adverse events
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Asthma, Bulgaria
- Sponsor type
- University, hospital or other
- Collaborators
- Nasaleze
- Responsible party
- Principal investigator, Prof. Todor Popov, Association Asthma, Bulgaria
- Investigators
- Todor A Popov, MD, PhD, Principal investigator, Medical University Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986582
- Sponsor's protocol ID
- NoAL001
- Acronym
- NOPAR
- Status last verified
- Sep 2015
- First submitted
- 12 Nov 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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. doi: 10.1046/j.0306-5251.2001.01525.x.
PubMed 11849202Valerieva A, Popov TA, Staevska M, Kralimarkova T, Petkova E, Valerieva E, Mustakov T, Lazarova T, Dimitrov V, Church MK. Effect of micronized cellulose powder on the efficacy of topical oxymetazoline in allergic rhinitis. Allergy Asthma Proc. 2015 Nov-Dec;36(6):e134-9. doi: 10.2500/aap.2015.36.3879. Epub 2015 Jun 29.
PubMed 26133030
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01986582
- Acronym / sponsor ID
- NOPAR / NoAL001
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Congestion, Mucoadhesive Treatment, Nasal Decongestant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Association Asthma, BulgariaUniversity, hospital or other
- Collaborators
- Nasaleze
- Study start
- Oct 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 18 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Oxymetazoline, Other: Hydroxyl-propyl-methyl cellulose powderOne puff of oxymetazoline immediately followed by one puff of hydroxyl-propyl-methyl cellulose powder, morning \& evening, for 8 days. |
| Group B | Placebo comparator | Drug: Oxymetazoline, Other: Placebo (lactose powder)One puff of oxymetazoline immediately followed by one puff of placebo, morning \& evening, for 8 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxymetazolineAlso: AfrinIntranasal application | Drug | Group A, Group B |
| Hydroxyl-propyl-methyl cellulose powderAlso: NoAlIntranasal application | Other | Group A |
| Placebo (lactose powder)Intranasal application | Other | Group B |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Background: PubMed 11849202Tzachev 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. doi: 10.1046/j.0306-5251.2001.01525.x.
- Derived from this study: PubMed 26133030Valerieva A, Popov TA, Staevska M, Kralimarkova T, Petkova E, Valerieva E, Mustakov T, Lazarova T, Dimitrov V, Church MK. Effect of micronized cellulose powder on the efficacy of topical oxymetazoline in allergic rhinitis. Allergy Asthma Proc. 2015 Nov-Dec;36(6):e134-9. doi: 10.2500/aap.2015.36.3879. Epub 2015 Jun 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todor A Popov, MD, PhD principal investigator
Medical University Sofia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxymetazoline and Hydroxyl-propyl-methyl cellulose powder in people with Allergic Rhinitis, run by Association Asthma, Bulgaria at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01986582, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.