Allergic RhinitisPhase 4NCT02507635
Anti-inflammatory H1 Antihistamines Allergic Rhinitis
A Phase 4 study testing Levocetirizine and Desloratadine in people with Allergic Rhinitis, run by Iuliu Hatieganu University of Medicine and Pharmacy.
Trial summary
The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and patients' quality of life and prevent the development of asthma. Therapeutic strategies also target a reduction of pro-inflammatory mediators released from activated cells, including mast cells and epithelial cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Levocetirizine and Desloratadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to May 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- persistent allergic rhinitis
Who cannot join
- the presence of asthma or nasal polyps,
- acute and chronic upper respiratory infections,
- administration of intranasal or systemic corticosteroids or H1 antihistamines in the past 30 days.
About this study
Official title: In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis
The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and patients' quality of life and prevent the development of asthma. Therapeutic strategies also target a reduction of pro-inflammatory mediators released from activated cells, including mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may increase the risk of asthma occurrence, especially in patients with persistent allergic rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis, regardless of symptom severity or persistence. They control all of the symptoms, but to a lesser extent nasal congestion. New generation agents, such as levocetirizine and desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.
Read the detailed description
Allergic rhinitis is characterized by a chronic inflammation of nasal mucosa and represents a risk factor for asthma occurrence. H1 antihistamines reduce the rhinitis' symptoms, but some compounds may have anti-inflammatory properties.
We evaluated the plasmatic level of some cytokines in patients with persistent allergic rhinitis (PAR) and their evolution after 4-week treatment with H1 antihistamines and the risk of asthma after 1.5 year.
Eighty-five patients with PAR and 30 healthy volunteers were included in the study. The patients with PAR were randomly divided into 2 groups: 41 patients treated with desloratadine 5 mg/day and 44 patients under levocetirizine 5 mg/day for 4 weeks.
The clinical evaluation include the presence and severity of allergic rhinitis' symptoms: rhinorrhea, nasal congestion, sneezing, nasal and ocular itching and duration of the disease.
Each symptom was evaluated on scale from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe) and after that we calculated the total symptoms score (TSS).
A TSS<6 means a mild rhinitis, while a TSS> 6 represented a moderate severe one.
The patients were clinically evaluated after 1.5 year to determine the possible onset of bronchial asthma.
The biological evaluation means determination of total IgE and plasmatic level of IL-1 beta, IL-6, IL-8 and TNF alpha.
Clinical and biological evaluation were performed before and after treatment
- Conditions
- Allergic Rhinitis
- Being tested
- Levocetirizine, Desloratadine
- Keywords
- cytokines, persistent allergic rhinitis, H1 antihistamines
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
Also called Xyzal
administration of Levocetirizine 5 mg/day for 4 weeks
DesloratadineDrug
Also called Aerius
administration of Desloratadine 5 mg/day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | No intervention | healthy volunteers |
| Desloratadine | Active comparator | patients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks Receives: Drug: Desloratadine |
| Levocetirizine | Active comparator | patients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks Receives: Drug: Levocetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of H1 antihistamines (patients evaluation)
patients evaluation before and after 4-weeks treatment
Measured: 4 weeks
Secondary outcomes (1)
asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion)
incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startFeb 2009
- Primary completionNov 2011
- Study completionMay 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Cristian Vesa, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507635
- Sponsor's protocol ID
- 535
- Status last verified
- Jul 2015
- First submitted
- 17 Jul 2015
- Last updated
- 24 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bocsan CI, Bujor AI, Miron N, Vesa SC, Deleanu D, Buzoianu AD. In Vivo Anti-Inflammatory Effect of H1 Antihistamines in Allergic Rhinitis: A Randomized Clinical Trial. Balkan Med J. 2015 Oct;32(4):352-8. doi: 10.5152/balkanmedj.2015.15884. Epub 2015 Oct 1.
PubMed 26740893
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT02507635
- Acronym / sponsor ID
- 535
- Conditions
- Allergic Rhinitis
- Keywords
- cytokines, persistent allergic rhinitis, H1 antihistamines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Jul 2015 (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.
The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and patients' quality of life and prevent the development of asthma. Therapeutic strategies also target a reduction of pro-inflammatory mediators released from activated cells, including mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may increase the risk of asthma occurrence, especially in patients with persistent allergic rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis, regardless of symptom severity or persistence. They control all of the symptoms, but to a lesser extent nasal congestion. New generation agents, such as levocetirizine and desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.
Detailed description
Allergic rhinitis is characterized by a chronic inflammation of nasal mucosa and represents a risk factor for asthma occurrence. H1 antihistamines reduce the rhinitis' symptoms, but some compounds may have anti-inflammatory properties.
We evaluated the plasmatic level of some cytokines in patients with persistent allergic rhinitis (PAR) and their evolution after 4-week treatment with H1 antihistamines and the risk of asthma after 1.5 year.
Eighty-five patients with PAR and 30 healthy volunteers were included in the study. The patients with PAR were randomly divided into 2 groups: 41 patients treated with desloratadine 5 mg/day and 44 patients under levocetirizine 5 mg/day for 4 weeks.
The clinical evaluation include the presence and severity of allergic rhinitis' symptoms: rhinorrhea, nasal congestion, sneezing, nasal and ocular itching and duration of the disease.
Each symptom was evaluated on scale from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe) and after that we calculated the total symptoms score (TSS).
A TSS<6 means a mild rhinitis, while a TSS> 6 represented a moderate severe one.
The patients were clinically evaluated after 1.5 year to determine the possible onset of bronchial asthma.
The biological evaluation means determination of total IgE and plasmatic level of IL-1 beta, IL-6, IL-8 and TNF alpha.
Clinical and biological evaluation were performed before and after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | No intervention | –healthy volunteers |
| Desloratadine | Active comparator | Drug: Desloratadinepatients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks |
| Levocetirizine | Active comparator | Drug: Levocetirizinepatients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persistent allergic rhinitis
Key exclusion criteria (3 listed)
- the presence of asthma or nasal polyps,
- acute and chronic upper respiratory infections,
- administration of intranasal or systemic corticosteroids or H1 antihistamines in 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 |
|---|---|---|
| LevocetirizineAlso: Xyzaladministration of Levocetirizine 5 mg/day for 4 weeks | Drug | Levocetirizine |
| DesloratadineAlso: Aeriusadministration of Desloratadine 5 mg/day for 4 weeks | Drug | Desloratadine |
Primary outcome
efficacy of H1 antihistamines (patients evaluation)
Time frame: 4 weeks
patients evaluation before and after 4-weeks treatment
1 secondary outcome
asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion)
Time frame: 1.5 years
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 24 Jul 2015.
- Derived from this study: PubMed 26740893Bocsan CI, Bujor AI, Miron N, Vesa SC, Deleanu D, Buzoianu AD. In Vivo Anti-Inflammatory Effect of H1 Antihistamines in Allergic Rhinitis: A Randomized Clinical Trial. Balkan Med J. 2015 Oct;32(4):352-8. doi: 10.5152/balkanmedj.2015.15884. Epub 2015 Oct 1.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levocetirizine and Desloratadine in people with Allergic Rhinitis, run by Iuliu Hatieganu University of Medicine and Pharmacy.
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 1 inclusion and 3 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 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
efficacy of H1 antihistamines (patients evaluation) (time frame: 4 weeks). 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 NCT02507635, 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 24 Jul 2015.