Allergic RhinitisNCT05896241
EVALUATION OF THE EFFECTIVENESS AND SAFETY OF DOSPRAY® NAZAL SPRAY IN THE SYMPTOMATIC TREATMENT OF PERSISTENT ALLERGIC RHINITIS: A POST-REGISTRATION OBSERVATION STUDY
An observational study of Allergic Rhinitis, run by LeKos LLP at 2 sites in Kazakhstan.
Trial summary
The combined use of dexamethasone and oxymetazoline has a vasoconstrictive, anti-inflammatory and anti-allergic effect when applied topically in diseases of the upper respiratory tract. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- non-interventional study
- How many people
- 126 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 15 May 2023to 15 Dec 2023
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons aged ≥18 to 65 years inclusive with a diagnosis of persistent allergic rhinitis who are under outpatient observation.
Who may be able to join
- Persons aged 18 to 65 years
- Total TNSS score on the day of inclusion in the study equal to or greater than 4.
- Patients who were prescribed the drug Dospray® or other symptomatic treatment as part of routine medical practice outside the study.
- Voluntary desire to provide informed consent to participate in the study.
Who cannot join
- Objective symptoms suggestive of renal, hepatic, or heart failure;
- Pregnant and lactating women;
- Patients taking systemic steroids within 30 days prior to inclusion in the study;
- Use of nasal sprays containing corticosteroids within 30 days prior to enrollment in the study;
- Patients receiving immunomodulatory therapy (including Allergen specific immunotherapy (ASIT));
- Patients taking drugs for the treatment of bronchial asthma;
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- Patients with polyps in the nasal cavity and / or deformity of the nasal septum requiring surgical correction;
- Infectious diseases of the upper respiratory tract within 14 days before enrollment in the study;
- Patients prone to nosebleeds, having glaucoma, convulsive syndrome or other neuropsychiatric pathologies.
Trial locations and contacts
2 sites in 1 country.
Kazakhstan2 sites, 2 recruiting
- Recruiting
Allergo Clinic Medical Center
Almaty, 050043
Danara Artygalieva, MD, 77019383408, artdanara77@gmail.com
chief physician, +77782496666, allergoclinic@mail.ru
- Recruiting
LLP LOR-Center Ai-Medicus
Almaty
Indira Dzhusupova, MD, 77770956788, jussupova.indira@mail.ru
Adilet Duisenbaev, MD
About this study
The combined use of dexamethasone and oxymetazoline has a vasoconstrictive, anti-inflammatory and anti-allergic effect when applied topically in diseases of the upper respiratory tract.
The main goal of this research is Evaluation of the effectiveness of Dospray® nasal spray in the treatment of persistent allergic rhinitis.
The study will involve 126 patients diagnosed with allergic rhinitis:
- Patients taking Dospray = 63
- Patients on other alternative treatment = 63 Duration of Patient Participation - 7-10 days (duration of treatment for an individual patient).
Read the detailed description
Primary task: Overall assessment of the effectiveness of Dospray® nasal spray in the treatment of persistent allergic rhinitis.
Secondary Tasks:
- Symptomatic evaluation of the effectiveness of Dospray® nasal spray in the treatment of persistent allergic rhinitis;
- Evaluation of the effect of Dospray® nasal spray on conjunctive symptoms in the treatment of persistent allergic rhinitis;
- Evaluation of the effect of Dospray® nasal spray on the severity and frequency of nasal symptoms in the treatment of persistent allergic rhinitis;
- Assessment of the quality of life before and after the use of Dospray® nasal spray in the treatment of persistent allergic rhinitis;
- Safety assessment of the use of nasal spray Dospray®.
Study Endpoints:
- Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS) [Time: 7 days]
- Dynamics of scores on the scale of the individual reflective Total nasal symptoms score (iTNSS) [Time: 7 days]
- Dynamics of scores on the scale of the reflective Total ocular symptom score (rTOSS)
- Changes in Visual Analogue Scale (VAS) scores for the severity and frequency of nasal symptoms [Time: 7 days].
- Dynamics of scores on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores [Time: 7 days]
- Adverse reactions [Time: 7 days] Number of yellow cards.
- Conditions
- Allergic Rhinitis
- Being tested
- non-interventional study
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventional studyOther
non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Patients taking Dospray = 63 | Patients who were prescribed Dospray as part of routine medical practice Receives: Other: non-interventional study | |
| Рatients on other alternative treatment = 63 | Patients who have been prescribed other alternative treatment as part of routine medical practice Receives: Other: non-interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS)
Measured: [Time: 7 days]
Secondary outcomes (5)
Dynamics of scores on the scale of the individual reflective Total nasal symptoms score (iTNSS)
Measured: [Time: 7 days]
Dynamics of scores on the scale of the reflective Total ocular symptom score (rTOSS)
Measured: [Time: 7 days]
Changes in Visual Analogue Scale (VAS) scores for the severity and frequency of nasal symptoms.
Measured: [Time: 7 days]
Dynamics of scores on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores
Measured: [Time: 7 days]
Adverse reactions - Number of yellow cards.
Measured: [Time: 7 days]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start15 May 2023
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- LeKos LLP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896241
- Sponsor's protocol ID
- № LK-01-D
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECTIVENESS AND SAFETY OF DOSPRAY® NAZAL SPRAY IN THE SYMPTOMATIC TREATMENT OF PERSISTENT ALLERGIC RHINITIS: A POST-REGISTRATION OBSERVATION STUDY
- ClinicalTrials.gov ID
- NCT05896241
- Acronym / sponsor ID
- № LK-01-D
- Conditions
- Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- LeKos LLPIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 9 Jun 2023 (actual)
- 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.
The combined use of dexamethasone and oxymetazoline has a vasoconstrictive, anti-inflammatory and anti-allergic effect when applied topically in diseases of the upper respiratory tract.
The main goal of this research is Evaluation of the effectiveness of Dospray® nasal spray in the treatment of persistent allergic rhinitis.
The study will involve 126 patients diagnosed with allergic rhinitis:
- Patients taking Dospray = 63
- Patients on other alternative treatment = 63 Duration of Patient Participation - 7-10 days (duration of treatment for an individual patient).
Detailed description
Primary task: Overall assessment of the effectiveness of Dospray® nasal spray in the treatment of persistent allergic rhinitis.
Secondary Tasks:
- Symptomatic evaluation of the effectiveness of Dospray® nasal spray in the treatment of persistent allergic rhinitis;
- Evaluation of the effect of Dospray® nasal spray on conjunctive symptoms in the treatment of persistent allergic rhinitis;
- Evaluation of the effect of Dospray® nasal spray on the severity and frequency of nasal symptoms in the treatment of persistent allergic rhinitis;
- Assessment of the quality of life before and after the use of Dospray® nasal spray in the treatment of persistent allergic rhinitis;
- Safety assessment of the use of nasal spray Dospray®.
Study Endpoints:
- Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS) [Time: 7 days]
- Dynamics of scores on the scale of the individual reflective Total nasal symptoms score (iTNSS) [Time: 7 days]
- Dynamics of scores on the scale of the reflective Total ocular symptom score (rTOSS)
- Changes in Visual Analogue Scale (VAS) scores for the severity and frequency of nasal symptoms [Time: 7 days].
- Dynamics of scores on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores [Time: 7 days]
- Adverse reactions [Time: 7 days] Number of yellow cards.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients taking Dospray = 63 | – | Other: non-interventional studyPatients who were prescribed Dospray as part of routine medical practice |
| Рatients on other alternative treatment = 63 | – | Other: non-interventional studyPatients who have been prescribed other alternative treatment as part of routine medical practice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons aged ≥18 to 65 years inclusive with a diagnosis of persistent allergic rhinitis who are under outpatient observation.
Key inclusion criteria (4 listed)
- Persons aged 18 to 65 years
- Total TNSS score on the day of inclusion in the study equal to or greater than 4.
- Patients who were prescribed the drug Dospray® or other symptomatic treatment as part of routine medical practice outside the study.
- Voluntary desire to provide informed consent to participate in the study.
Key exclusion criteria (9 listed)
- Objective symptoms suggestive of renal, hepatic, or heart failure;
- Pregnant and lactating women;
- Patients taking systemic steroids within 30 days prior to inclusion in the study;
- Use of nasal sprays containing corticosteroids within 30 days prior to enrollment in the study;
- Patients receiving immunomodulatory therapy (including Allergen specific immunotherapy (ASIT));
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 |
|---|---|---|
| non-interventional studynon-interventional study | Other | Patients taking Dospray = 63, Рatients on other alternative treatment = 63 |
Primary outcome
Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS)
Time frame: [Time: 7 days]
5 secondary outcomes
Dynamics of scores on the scale of the individual reflective Total nasal symptoms score (iTNSS)
Time frame: [Time: 7 days]
Dynamics of scores on the scale of the reflective Total ocular symptom score (rTOSS)
Time frame: [Time: 7 days]
Changes in Visual Analogue Scale (VAS) scores for the severity and frequency of nasal symptoms.
Time frame: [Time: 7 days]
Dynamics of scores on the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores
Time frame: [Time: 7 days]
Adverse reactions - Number of yellow cards.
Time frame: [Time: 7 days]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by LeKos LLP at 2 sites in Kazakhstan.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aigul Medeulova, MD (+7 701 421 77 65, medeulova@bk.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamics of scores on the scale of the reflective Total nasal symptoms score (TNSS) (time frame: [Time: 7 days]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2023.