Allergic RhinitisPhase 2/3CPARGPDBPCNCT03039816
Cellulose Powder Against Grass Pollen Allergic Rhinitis
A Phase 2/3 study testing Nasaleze in people with Allergic Rhinitis, run by Nasaleze International Ltd at 3 sites in 2 countries.
Trial summary
Background: A nasally applied cellulose powder is increasingly used in many countries as a remedy for allergic rhinitis. In 2009, a 4-week study in birch pollen-allergic children showed a reduction in nasal symptoms. The best effect occurred on days with lower pollen counts. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Nasaleze
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2013to Nov 2013
- Phase
- Phase 2/3
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with a history of typical symptoms of hay fever during late spring or early summer
- Mild or moderate severity of symptoms of seasonal allergic rhinitis.
- Positive allergy test for grass pollen allergy.
- Voluntarily given written informed consent to study participation encompassing consent to data recording and verification procedures;
- Patients are able and willing to comply with the requirements of the study protocol.
- Patients who have not received any pollen disease treatment for one week prior to the study.
Who cannot join
- Previous treatment with nasal steroids or current indications for the administration of nasal steroids.
- Nasal symptoms during all seasons of the year or during spring time preceding the grass pollen season.
- Clinical signs of predominating nasal obstruction. The patient must be judged to be able to reach the nasal cavity with the study powder.
- Other respiratory or chronic diseases.
- Previous use of the study product
- Inability to give informed consent
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Ukraine2 sites
Mechanikov Dnipropetrovsk Regional Clinical Hospital, Departmnet of Profpathology, Zhovteneva sq 14
Dnipro, 49106
Kharkiv National Medical University Department of Internal medicine propedeutics No 2 4 Lenin str
Kharkiv, 61022
Sweden1 site
Departments of Pediatrics and Biological and Environmental Sciences
Gothenburg
About this study
Official title: A Nasally Applied Cellulose Powder in Seasonal Allergic Rhinitis in Adults With Grass Pollen Allergy: A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study
Background: A nasally applied cellulose powder is increasingly used in many countries as a remedy for allergic rhinitis. In 2009, a 4-week study in birch pollen-allergic children showed a reduction in nasal symptoms. The best effect occurred on days with lower pollen counts. The present study in grass pollen-allergic adults used the same basic design. Methods: In May 2013, a double-blind, placebo-controlled study was conducted in 108 patients with allergic rhinitis due to grass pollen (18-40 years of age). SMS on mobile phones were used as reminders of treatment and reporting of symptom scores.
Read the detailed description
The study was performed at university clinics in Kharkiv and Dnepropetrovsk in Ukraine in May 2013. 108 subjects 18-40 years of age were recruited locally to 2 centres. They all had a history of typical symptoms of seasonal allergic rhinitis (SAR) during late spring - early summer. At first appointment the history was scrutinized and an assessment of the severity excluded previous use of nasal steroids or a current need for nasal steroids. They should not have perennial symptoms or a history of asthma. They were tested with a blood sample for ImmunoCAP Specific Immunoglobulin E (IgE) for timothy grass pollen and birch pollen, with >0.35 Kilounits (kU)/ml counted as positive.
The patients were randomly assigned to active or placebo in groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variations of patterns of deposition in the nose are not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder.
Rescue medication could be obtained by the investigators after emergency contacts. Oral antihistamine was loratadine 10 mg tablets and sodium chromoglycate eye drops. Each subject obtained oral and written instructions about the SMS. The SMS-reporting of symptoms started with a run in period for 3 days before the treatment and lasted for the 4 weeks of treatment during the grass pollen season
Three times a day the patients were reminded by SMS to take their nasal puffs and were asked to confirm the intake by a response SMS. In the evening, they were asked about the severity of symptoms during the preceding day from the nose, eyes and lower airways and to answer with a figure 1-6, corresponding to 1 "no trouble at all", 2"little trouble", 3"moderate trouble", 4"rather much trouble", 5"much trouble", and 6 "very much trouble" respectively. From the nose, scoring of sneezing, running nose and blocked nose were reported. For the eyes and lower airways, respectively, only a concluding figure was used.
In the registration a question was added daily on the use of rescue medication.
At a concluding appointment after the treatment period, the subjects were asked about their global opinion of the efficacy: No effect, good effect, very good effect. They also were asked whether they believed they had obtained the active substance or placebo.
The study was performed at university clinics in Kharkiv and Dnepropetrovsk in Ukraine in May 2013. 108 subjects 18-40 years of age were recruited locally to 2 centres. They all had a history of typical symptoms of SAR during late spring - early summer. At first appointment the history was scrutinized and an assessment of the severity excluded previous use of nasal steroids or a current need for nasal steroids. They should not have perennial symptoms or a history of asthma. They were tested with a blood sample for ImmunoCAP Specific IgE for timothy grass pollen and birch pollen, with >0.35 kU/ml counted as positive.
The patients were randomly assigned to active or placebo in groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variations of patterns of deposition in the nose are not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder.
Rescue medication could be obtained by the investigators after emergency contacts. Oral antihistamine was loratadine 10 mg tablets and sodium cromoglycate eye drops. Each subject obtained oral and written instructions about the SMS. The SMS-reporting of symptoms started with a run in period for 3 days before the treatment and lasted for the 4 weeks of treatment during the grass pollen season
Three times a day the patients were reminded by SMS to take their nasal puffs and were asked to confirm the intake by a response SMS. In the evening, they were asked about the severity of symptoms during the preceding day from the nose, eyes and lower airways and to answer with a figure 1-6, corresponding to 1 "no trouble at all", 2"little trouble", 3"moderate trouble", 4"rather much trouble", 5"much trouble", and 6 "very much trouble" respectively. From the nose, scoring of sneezing, running nose and blocked nose were reported. For the eyes and lower airways, respectively, only a concluding figure was used.
In the registration a question was added daily on the use of rescue medication.
At a concluding appointment after the treatment period, the subjects were asked about their global opinion of the efficacy: No effect, good effect, very good effect. They also were asked whether they believed they had obtained the active substance or placebo.
Statistical methods For each question the mean score was calculated for the whole 28 days period for every subject. Mean values for the sum of all scores as well as the sum of the nasal scores were also calculated. The scores from the two treatment groups were then compared using t-tests. The group comparison of reflective opinions and the guess on obtained medication at the follow up visit were assessed using the Chi-square test.
The concluding opinion at the follow up visit were analysed using the chi-square test.
The study was approved by the local ethics committees at the respective hospitals.
- Conditions
- Allergic Rhinitis
- Being tested
- Nasaleze, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NasalezeDevice
Also called Nasaval
Nasaleze cellulose powder
PlaceboDevice
Lactose powder in the same plastic container as Nasaleze and with the same taste
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | The patients were randomly assigned to active (Nasaleze cellulose powder) or placebo groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variation in the patterns of deposition in the nose is not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder. Receives: Device: Nasaleze |
| Placebo | Placebo comparator | The patients were randomly assigned to active or placebo groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variation in the patterns of deposition in the nose is not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of allergic rhinitis
Group total of symptoms scored retrospectively once daily
Measured: Day 1-28 of treatment period
Secondary outcomes (4)
Adverse events
Answer on daily question on Short Message Service (SMS) during treatment and supplementing interview at concluding appointment
Measured: Day 1-28 and day 32
Use of rescue medication
Daily answer on SMS question on possible use of rescue medication
Measured: Treatment period day 1-28
Global opinion of the efficacy
Questions on alternatives "No effect, good effect, very good effect
Measured: Day 32, after completed treatment
Guess on obtained treatment
Question on whether they believed they had obtained the active substance or placebo.
Measured: Day 32, after completed treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nasaleze International Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039816
- Sponsor's protocol ID
- NIL001/2013
- Acronym
- CPARGPDBPC
- Status last verified
- Jan 2017
- First submitted
- 12 Dec 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aberg N, Ospanova ST, Nikitin NP, Emberlin J, Dahl A. A nasally applied cellulose powder in seasonal allergic rhinitis in adults with grass pollen allergy: a double-blind, randomized, placebo-controlled, parallel-group study. Int Arch Allergy Immunol. 2014;163(4):313-8. doi: 10.1159/000360734. Epub 2014 Apr 29.
PubMed 24852424
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nasally Applied Cellulose Powder in Seasonal Allergic Rhinitis in Adults With Grass Pollen Allergy: A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study
- ClinicalTrials.gov ID
- NCT03039816
- Acronym / sponsor ID
- CPARGPDBPC / NIL001/2013
- Conditions
- Allergic Rhinitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Nasaleze International LtdIndustry (pharma, biotech, devices)
- Collaborators
- Göteborg University
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 1 Feb 2017 (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.
Background: A nasally applied cellulose powder is increasingly used in many countries as a remedy for allergic rhinitis. In 2009, a 4-week study in birch pollen-allergic children showed a reduction in nasal symptoms. The best effect occurred on days with lower pollen counts. The present study in grass pollen-allergic adults used the same basic design. Methods: In May 2013, a double-blind, placebo-controlled study was conducted in 108 patients with allergic rhinitis due to grass pollen (18-40 years of age). SMS on mobile phones were used as reminders of treatment and reporting of symptom scores.
Detailed description
The study was performed at university clinics in Kharkiv and Dnepropetrovsk in Ukraine in May 2013. 108 subjects 18-40 years of age were recruited locally to 2 centres. They all had a history of typical symptoms of seasonal allergic rhinitis (SAR) during late spring - early summer. At first appointment the history was scrutinized and an assessment of the severity excluded previous use of nasal steroids or a current need for nasal steroids. They should not have perennial symptoms or a history of asthma. They were tested with a blood sample for ImmunoCAP Specific Immunoglobulin E (IgE) for timothy grass pollen and birch pollen, with >0.35 Kilounits (kU)/ml counted as positive.
The patients were randomly assigned to active or placebo in groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variations of patterns of deposition in the nose are not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder.
Rescue medication could be obtained by the investigators after emergency contacts. Oral antihistamine was loratadine 10 mg tablets and sodium chromoglycate eye drops. Each subject obtained oral and written instructions about the SMS. The SMS-reporting of symptoms started with a run in period for 3 days before the treatment and lasted for the 4 weeks of treatment during the grass pollen season
Three times a day the patients were reminded by SMS to take their nasal puffs and were asked to confirm the intake by a response SMS. In the evening, they were asked about the severity of symptoms during the preceding day from the nose, eyes and lower airways and to answer with a figure 1-6, corresponding to 1 "no trouble at all", 2"little trouble", 3"moderate trouble", 4"rather much trouble", 5"much trouble", and 6 "very much trouble" respectively. From the nose, scoring of sneezing, running nose and blocked nose were reported. For the eyes and lower airways, respectively, only a concluding figure was used.
In the registration a question was added daily on the use of rescue medication.
At a concluding appointment after the treatment period, the subjects were asked about their global opinion of the efficacy: No effect, good effect, very good effect. They also were asked whether they believed they had obtained the active substance or placebo.
The study was performed at university clinics in Kharkiv and Dnepropetrovsk in Ukraine in May 2013. 108 subjects 18-40 years of age were recruited locally to 2 centres. They all had a history of typical symptoms of SAR during late spring - early summer. At first appointment the history was scrutinized and an assessment of the severity excluded previous use of nasal steroids or a current need for nasal steroids. They should not have perennial symptoms or a history of asthma. They were tested with a blood sample for ImmunoCAP Specific IgE for timothy grass pollen and birch pollen, with >0.35 kU/ml counted as positive.
The patients were randomly assigned to active or placebo in groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variations of patterns of deposition in the nose are not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder.
Rescue medication could be obtained by the investigators after emergency contacts. Oral antihistamine was loratadine 10 mg tablets and sodium cromoglycate eye drops. Each subject obtained oral and written instructions about the SMS. The SMS-reporting of symptoms started with a run in period for 3 days before the treatment and lasted for the 4 weeks of treatment during the grass pollen season
Three times a day the patients were reminded by SMS to take their nasal puffs and were asked to confirm the intake by a response SMS. In the evening, they were asked about the severity of symptoms during the preceding day from the nose, eyes and lower airways and to answer with a figure 1-6, corresponding to 1 "no trouble at all", 2"little trouble", 3"moderate trouble", 4"rather much trouble", 5"much trouble", and 6 "very much trouble" respectively. From the nose, scoring of sneezing, running nose and blocked nose were reported. For the eyes and lower airways, respectively, only a concluding figure was used.
In the registration a question was added daily on the use of rescue medication.
At a concluding appointment after the treatment period, the subjects were asked about their global opinion of the efficacy: No effect, good effect, very good effect. They also were asked whether they believed they had obtained the active substance or placebo.
Statistical methods For each question the mean score was calculated for the whole 28 days period for every subject. Mean values for the sum of all scores as well as the sum of the nasal scores were also calculated. The scores from the two treatment groups were then compared using t-tests. The group comparison of reflective opinions and the guess on obtained medication at the follow up visit were assessed using the Chi-square test.
The concluding opinion at the follow up visit were analysed using the chi-square test.
The study was approved by the local ethics committees at the respective hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Device: NasalezeThe patients were randomly assigned to active (Nasaleze cellulose powder) or placebo groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variation in the patterns of deposition in the nose is not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder. |
| Placebo | Placebo comparator | Device: PlaceboThe patients were randomly assigned to active or placebo groups using an identical device to be puffed in each nostril 3 times daily. The nasal powders were supplied in plastic containers, which deliver the powder from a nozzle when squeezed. The exact amount delivered is not standardized and the variation in the patterns of deposition in the nose is not known. The placebo was a lactose powder with the same particle size, appearance and the same tinge of mint taste as the cellulose powder. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient with a history of typical symptoms of hay fever during late spring or early summer
- Mild or moderate severity of symptoms of seasonal allergic rhinitis.
- Positive allergy test for grass pollen allergy.
- Voluntarily given written informed consent to study participation encompassing consent to data recording and verification procedures;
- Patients are able and willing to comply with the requirements of the study protocol.
Key exclusion criteria (6 listed)
- Previous treatment with nasal steroids or current indications for the administration of nasal steroids.
- Nasal symptoms during all seasons of the year or during spring time preceding the grass pollen season.
- Clinical signs of predominating nasal obstruction. The patient must be judged to be able to reach the nasal cavity with the study powder.
- Other respiratory or chronic diseases.
- Previous use of the study product
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 |
|---|---|---|
| NasalezeAlso: NasavalNasaleze cellulose powder | Device | Active |
| PlaceboLactose powder in the same plastic container as Nasaleze and with the same taste | Device | Placebo |
Primary outcome
Symptoms of allergic rhinitis
Time frame: Day 1-28 of treatment period
Group total of symptoms scored retrospectively once daily
4 secondary outcomes
Adverse events
Time frame: Day 1-28 and day 32
Use of rescue medication
Time frame: Treatment period day 1-28
Global opinion of the efficacy
Time frame: Day 32, after completed treatment
Guess on obtained treatment
Time frame: Day 32, after completed treatment
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 1 Feb 2017.
- Results publication: PubMed 24852424Aberg N, Ospanova ST, Nikitin NP, Emberlin J, Dahl A. A nasally applied cellulose powder in seasonal allergic rhinitis in adults with grass pollen allergy: a double-blind, randomized, placebo-controlled, parallel-group study. Int Arch Allergy Immunol. 2014;163(4):313-8. doi: 10.1159/000360734. Epub 2014 Apr 29.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Nasaleze in people with Allergic Rhinitis, run by Nasaleze International Ltd at 3 sites in 2 countries.
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 6 inclusion and 6 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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ukraine, Sweden. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Symptoms of allergic rhinitis (time frame: Day 1-28 of treatment period). 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 NCT03039816, which also lists 1 linked publication.
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 1 Feb 2017.