Allergic RhinitisNCT04561687
Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis
A study testing Montelukast, Azelastine and Budesonide in people with Allergic Rhinitis, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Comparison of Montelukast and Azelastine In treatment of Allergic Rhinitis Allergic intent is one of the most common diseases of the respiratory system that has a devastating effect on the quality of life. The importance of studying this disease can be seen from the high prevalence of this diseas. Read more about this study
- Who is it for?
- Ages 6 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Montelukast, Azelastine and Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteIran
- Study dates
- 16 Jan 2020to 15 Dec 2021
- Phase
- Interventional
- 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 6 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 6-50years
- Moderate to severe allergic rhinitis
Who cannot join
- Under any treatment
- Drug sensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of Montelukast and Azelastine In treatment of Allergic Rhinitis Allergic intent is one of the most common diseases of the respiratory system that has a devastating effect on the quality of life. The importance of studying this disease can be seen from the high prevalence of this diseas. In addition to the high prevalence, due to the reducing effect of this disease on the economy and academic performance of patients, a great burden is imposed by this disease on the country's health care system.Also finding the best treatment of allergic can help to control of Asthma if exists concurrently.
Inflammation of the nasal mucosa following the release of IgE can be shown as symptoms of runny nose, sneezing, nasal congestion.Many studies have been done in the field of allergic rhinitis to increase the cost-effectiveness of treatment of this complication. Among the treatments for this disease is the use of antihistamine nasal sprays such as Azelastine. Combination therapies such as combining Mometason furoate or fluticasone with Azelastine or Montelukast can also be mentioned. However, there is still a long way to go to find the best drug combination to reduce the economic and human costs to the global health system. Due to the high prevalence of allergic diseases such as allergic rhinitis, finding the best treatment or management of such diseases plays an important role in improving the quality of life and reducing the economic burden on society.
- Conditions
- Allergic Rhinitis
- Being tested
- Montelukast, Azelastine, Budesonide, 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.
MontelukastDrug
Montelukast and nasal budesonide
AzelastineDrug
Azelastine and nasal budesonide
BudesonideDrug
To all groups
PlaceboDrug
Placebo and nasal budesonide
| Study group | Role | What they receive |
|---|---|---|
| Azelastine and Nasal Budesonide | Active comparator | Spray nasal Azelastine 1puff daily for 6-12years old patients and 2puff for older Receives: Drug: Azelastine; Drug: Budesonide |
| Montelukast and Nasal budesonide | Active comparator | Montelukast 5mg 6-14years old and 10mg for older Receives: Drug: Montelukast; Drug: Budesonide |
| Nasal Budesonide and Placebo | Placebo comparator | Placebo once daily Receives: Drug: Budesonide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sino-Nasal Outcome Test scores (SNOT-22)
Change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be.
Measured: Baseline,month1,month3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start16 Jan 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion15 Dec 2021 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasrin Mortazavi Far, Shiraz University of Medical Sciences
- Investigators
- Nasrin Mortazavi, Principal investigator, Shiraz University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561687
- Sponsor's protocol ID
- 98-01-49-21547
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Montelukast and Azelastine in Treatment of Moderate to Severe Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT04561687
- Acronym / sponsor ID
- 98-01-49-21547
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 24 Sep 2020 (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.
Comparison of Montelukast and Azelastine In treatment of Allergic Rhinitis Allergic intent is one of the most common diseases of the respiratory system that has a devastating effect on the quality of life. The importance of studying this disease can be seen from the high prevalence of this diseas. In addition to the high prevalence, due to the reducing effect of this disease on the economy and academic performance of patients, a great burden is imposed by this disease on the country's health care system.Also finding the best treatment of allergic can help to control of Asthma if exists concurrently.
Inflammation of the nasal mucosa following the release of IgE can be shown as symptoms of runny nose, sneezing, nasal congestion.Many studies have been done in the field of allergic rhinitis to increase the cost-effectiveness of treatment of this complication. Among the treatments for this disease is the use of antihistamine nasal sprays such as Azelastine. Combination therapies such as combining Mometason furoate or fluticasone with Azelastine or Montelukast can also be mentioned. However, there is still a long way to go to find the best drug combination to reduce the economic and human costs to the global health system. Due to the high prevalence of allergic diseases such as allergic rhinitis, finding the best treatment or management of such diseases plays an important role in improving the quality of life and reducing the economic burden on society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Azelastine and Nasal Budesonide | Active comparator | Drug: Azelastine, Drug: BudesonideSpray nasal Azelastine 1puff daily for 6-12years old patients and 2puff for older |
| Montelukast and Nasal budesonide | Active comparator | Drug: Montelukast, Drug: BudesonideMontelukast 5mg 6-14years old and 10mg for older |
| Nasal Budesonide and Placebo | Placebo comparator | Drug: Budesonide, Drug: PlaceboPlacebo once daily |
Who may qualify
- Ages
- 6 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 6-50years
- Moderate to severe allergic rhinitis
Key exclusion criteria (2 listed)
- Under any treatment
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 |
|---|---|---|
| MontelukastMontelukast and nasal budesonide | Drug | Montelukast and Nasal budesonide |
| AzelastineAzelastine and nasal budesonide | Drug | Azelastine and Nasal Budesonide |
| BudesonideTo all groups | Drug | Azelastine and Nasal Budesonide, Montelukast and Nasal budesonide, Nasal Budesonide and Placebo |
| PlaceboPlacebo and nasal budesonide | Drug | Nasal Budesonide and Placebo |
Primary outcome
Change in Sino-Nasal Outcome Test scores (SNOT-22)
Time frame: Baseline,month1,month3
Change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
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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.
Nasrin Mortazavi principal investigator
Shiraz University of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Montelukast, Azelastine and Budesonide in people with Allergic Rhinitis, run by Shiraz University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 2 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 25 Sep 2020. 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 Iran. 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.
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 Nasrin Mortazavi Far (989195774656, nasrinmortazavi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sino-Nasal Outcome Test scores (SNOT-22) (time frame: Baseline,month1,month3). 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 25 Sep 2020.