Seasonal Allergic RhinitisPhase 4NCT00488176
Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
A Phase 4 study testing montelukast, cetirizine and montelukast and cetirizine in people with Seasonal Allergic Rhinitis, run by Medical University of Lodz at 1 site in Poland.
Trial summary
The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- montelukast, cetirizine and montelukast and cetirizine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2007to Dec 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- clinical symptoms of seasonal allergic rhinitis during last two seasons, moderate and severe according to ARIA guidelines
Who cannot join
- diagnosis of bronchial asthma
- allergy to perennial allergens
- specific immunotherapy
- other chronic diseases
- tobacco smoking
- acute respiratory tract infection
- excluded drugs: inhaled and systemic glucocorticosteroids
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatrics and Allergy, Medical University of Lodz Lodz, Poland
Lodz, 93-513
Violetta Ścibiorek, MD, 00 48 42 689 59 72, alergol@kopernik.lodz.pl
Iwona Stelmach, MD, PhD, Prof
About this study
Official title: Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation Measured by Exhaled Nitric Oxide Concentration in Children With Seasonal Allergic Rhinitis
The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.
Read the detailed description
During the pollen season children with seasonal allergic rhinitis without concomitant asthma are at risk of having allergic inflammation in the lower respiratory tract. About 60% of children with seasonal allergic rhinitis present bronchial hyperresponsiveness and signs and symptoms of asthma.
The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- montelukast, cetirizine, montelukast and cetirizine, placebo
- Keywords
- seasonal allergic rhinitis, children, montelukast, cetirizine
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukastDrug
Also called montelukast sodium
montelukast sodium
cetirizineDrug
cetirizine
montelukast and cetirizineDrug
montelukast and cetirizine
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | monteluksat sodium Receives: Drug: montelukast |
| 2 | Active comparator | cetirizine Receives: Drug: cetirizine |
| 3 | Active comparator | montelukast sodium and cetirizine Receives: Drug: montelukast and cetirizine |
| 4 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
exhaled nitric oxide concentration
Measured: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)
Secondary outcomes (1)
symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements
Measured: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionNov 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iwona Stelmach, Medical University of Lodz
- Investigators
- Violetta Ścibiorek, MD, Principal investigator, Department of Pediatrics and Allergy, Medical University of Lodz, PolandIwona Stelmach, MD PhD Prof, Study chair, Department of Pediatrics and Allergy, Medical University of Lodz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488176
- Sponsor's protocol ID
- RNN/94/07KE
- Status last verified
- Feb 2013
- First submitted
- 19 Jun 2007
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation Measured by Exhaled Nitric Oxide Concentration in Children With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00488176
- Acronym / sponsor ID
- RNN/94/07KE
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- seasonal allergic rhinitis, children, montelukast, cetirizine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 Jun 2007 (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 aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.
Detailed description
During the pollen season children with seasonal allergic rhinitis without concomitant asthma are at risk of having allergic inflammation in the lower respiratory tract. About 60% of children with seasonal allergic rhinitis present bronchial hyperresponsiveness and signs and symptoms of asthma.
The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: montelukastmonteluksat sodium |
| 2 | Active comparator | Drug: cetirizinecetirizine |
| 3 | Active comparator | Drug: montelukast and cetirizinemontelukast sodium and cetirizine |
| 4 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- clinical symptoms of seasonal allergic rhinitis during last two seasons, moderate and severe according to ARIA guidelines
Key exclusion criteria (7 listed)
- diagnosis of bronchial asthma
- allergy to perennial allergens
- specific immunotherapy
- other chronic diseases
- tobacco smoking
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 |
|---|---|---|
| montelukastAlso: montelukast sodiummontelukast sodium | Drug | 1 |
| cetirizinecetirizine | Drug | 2 |
| montelukast and cetirizinemontelukast and cetirizine | Drug | 3 |
| placeboplacebo | Drug | 4 |
Primary outcome
exhaled nitric oxide concentration
Time frame: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)
1 secondary outcome
symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements
Time frame: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
Violetta Ścibiorek, MD principal investigator
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Iwona Stelmach, MD PhD Prof study chair
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing montelukast, cetirizine and montelukast and cetirizine in people with Seasonal Allergic Rhinitis, run by Medical University of Lodz at 1 site in Poland.
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 7 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 7 Feb 2013. 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 Poland. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Violetta Ścibiorek, MD (00 48 42 6895972, alergol@kopernik.lodz.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exhaled nitric oxide concentration (time frame: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)). 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 7 Feb 2013.