Rhinitis, Allergic, SeasonalPhase 3NCT00805324
Study of the Effectiveness and Safety of Desloratadine (Aerius) Syrup in Children With Hayfever With or Without Asthma (P03472)
A Phase 3 study testing Desloratadine in people with Rhinitis, Allergic, Seasonal and Asthma, run by Organon and Co.
Trial summary
The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with hayfever with or without asthma. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Rhinitis, Allergic, Seasonal, Asthma
- What is being tested?
- Desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Aug 2003
- Phase
- Phase 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children must be >= 6 to < 12 years of age of either sex and any race.
- Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent
- Children must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations
- Children's parent(s) or legal representative(s) must understand and be able to adhere to dosing and visit schedules, agree to report concomitant medications and adverse events to the Investigator or designee
- The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will be assessed by:
- Clinical history of sneezing, rhinorrhea (nasal discharge/running nose or post-nasal drip), nasal stuffiness/congestion and nasal itching and non-nasal symptoms (eye symptoms) as itching, burning, tearing and redness, during the previous pollen season
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- Ascertained skin prick positivity (or RAST positivity) to one of the following: grasses, parietaria, birch, hazelnut (the skin test has to be performed within the last year)
- Children must be clinically symptomatic with SAR at Visit 1 (day 1): the total (nasal + non nasal) symptoms score must be >= 8 with a nasal congestion score of >= 2, and the non-nasal symptoms severity score must be >= 2
- Asthma symptoms (wheezing, cough, difficulty breathing, chest tightness) will be evaluated at visit 1 (day 1) and graded only for child with concomitant asthma
Who cannot join
- Children who have not observed the designated washout periods for any of the prohibited medications
- Children with persistent asthma (mild, moderate or severe) or perennial allergic rhinitis (PAR)
- Children with rhinitis medicamentosa
- Children who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (day 1), or children who have had a viral upper respiratory infection within 7 days prior to Visit 1 (day 1)
- Children who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interfere with nasal airflow
- Children who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids
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- Children with a history of hypersensitivity to desloratadine or any of its excipients
- Children who have any current clinically significant metabolic, cardiovascular, hepatic, renal, immunologic, neurologic, hematologic, gastrointestinal, cerebrovascular or respiratory disease, or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect subject safety
- A known lack of response to H1-antihistamines
About this study
Official title: Evaluation of the Efficacy and Safety of Desloratadine Syrup in Children Suffering From Seasonal Allergic Rhinitis With or Without Intermittent Asthma
The purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with hayfever with or without asthma. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The doctor also rated how much relief the patient got from treatment and recorded any side effects.
- Conditions
- Rhinitis, Allergic, Seasonal, Asthma
- Being tested
- Desloratadine
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesloratadineDrug
Also called Clarinex; Aerius; SCH 34117; descarboethoxyloratadine
desloratadine syrup; 5.0 mL once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of the efficacy of desloratadine in relieving the total nasal/non-nasal symptoms of seasonal allergic rhinitis
Measured: Baseline, Day 8, Day 15, Day 29
Secondary outcomes (2)
To demonstrate that the Global Therapeutic Response is correlated with the degree of improvement of the total nasal/non-nasal symptoms severity score
Measured: Day 8, Day 15, Day 29
To evaluate the number of adverse events during the therapy
Measured: Day 8, Day 15, and Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startMay 2003
- Primary completionAug 2003
- Study completionAug 2003
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 Rhinitis, Allergic, SeasonalStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805324
- Sponsor's protocol ID
- P03472
- Status last verified
- Feb 2022
- First submitted
- 5 Dec 2008
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Rossi GA, Tosca MA, Passalacqua G, Bianchi B, Le Grazie C, Canonica GW. Evidence of desloratadine syrup efficacy and tolerability in children with pollen-induced allergic rhinitis. Allergy. 2005 Mar;60(3):416-7. doi: 10.1111/j.1398-9995.2005.00714.x. No abstract available.
PubMed 15679739
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Desloratadine Syrup in Children Suffering From Seasonal Allergic Rhinitis With or Without Intermittent Asthma
- ClinicalTrials.gov ID
- NCT00805324
- Acronym / sponsor ID
- P03472
- Conditions
- Rhinitis, Allergic, Seasonal, Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 9 Dec 2008 (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 purpose of this study was to test the effectiveness and safety of desloratadine (Aerius) syrup in children with hayfever with or without asthma. Patients took desloratadine syrup once a day for 28 days. Once a week, the doctor measured the patient's hayfever symptoms. The doctor also rated how much relief the patient got from treatment and recorded any side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Desloratadine |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children must be >= 6 to < 12 years of age of either sex and any race.
- Children's parent(s) or legal representative(s) must demonstrate their willingness to participate in the study and comply with its procedures by signing an informed consent
- Children must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations
- Children's parent(s) or legal representative(s) must understand and be able to adhere to dosing and visit schedules, agree to report concomitant medications and adverse events to the Investigator or designee
- The diagnosis of seasonal allergic rhinitis with or without intermittent asthma will be assessed by:
Key exclusion criteria (9 listed)
- Children who have not observed the designated washout periods for any of the prohibited medications
- Children with rhinitis medicamentosa
- Children who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (day 1), or children who have had a viral upper respiratory infection within 7 days prior to Visit 1 (day 1)
- Children who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interfere with nasal airflow
- Children who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids
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 |
|---|---|---|
| DesloratadineAlso: Clarinex; Aerius; SCH 34117; descarboethoxyloratadinedesloratadine syrup; 5.0 mL once daily for 28 days | Drug | Arm 1 |
Primary outcome
Demonstration of the efficacy of desloratadine in relieving the total nasal/non-nasal symptoms of seasonal allergic rhinitis
Time frame: Baseline, Day 8, Day 15, Day 29
2 secondary outcomes
To demonstrate that the Global Therapeutic Response is correlated with the degree of improvement of the total nasal/non-nasal symptoms severity score
Time frame: Day 8, Day 15, Day 29
To evaluate the number of adverse events during the therapy
Time frame: Day 8, Day 15, and Day 29
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 16 Feb 2022.
- Results publication: PubMed 15679739Rossi GA, Tosca MA, Passalacqua G, Bianchi B, Le Grazie C, Canonica GW. Evidence of desloratadine syrup efficacy and tolerability in children with pollen-induced allergic rhinitis. Allergy. 2005 Mar;60(3):416-7. doi: 10.1111/j.1398-9995.2005.00714.x. No abstract available.
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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 3 study testing Desloratadine in people with Rhinitis, Allergic, Seasonal and Asthma, run by Organon and Co.
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 9 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: finished, as of the sponsor's last update on 16 Feb 2022. 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 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?
Demonstration of the efficacy of desloratadine in relieving the total nasal/non-nasal symptoms of seasonal allergic rhinitis (time frame: Baseline, Day 8, Day 15, Day 29). 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 NCT00805324, 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 16 Feb 2022.