Rhinitis, Allergic, SeasonalPhase 4NCT00805584
Study of Nasal Symptom Relief and Side Effects in Hayfever Patients Treated With Aerius (Desloratadine)(P03442)
A Phase 4 study testing desloratadine in people with Rhinitis, Allergic, Seasonal, run by Organon and Co.
Trial summary
The purpose of this study was to test the effectiveness and side effects of desloratadine (Aerius) in patients with hayfever. Patients took desloratadine once a day for 15 days. At the end of therapy, they scored how severe their hayfever symptoms were and how they responded to therapy. Side effects were recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- 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
- 311 participants
- Where
- No sites listed yet
- Study dates
- May 2003to Jun 2003
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be >=18 years of age, of either sex and any race.
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control. Women who are not currently sexually active must agree and consent to use some sort of contraception should they become sexually active while participating in the study.
- Subjects must be in general good health, i.e., they must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations.
- Subjects must understand and be able to adhere to the dosing and visit schedules, and agree to report concomitant medications and adverse events to the Investigator or designee.
- Subjects must have at least a positive history, self-reported history of signs and symptoms is acceptable, of recurring seasonal allergic rhinitis
- Subjects must be clinically symptomatic with SAR at Visit 2 (Baseline): the total (nasal + non-nasal) symptom score must be >=8 points with a nasal congestion score of >=2, and the non-nasal symptom score must be >=2. Subjects may be rescheduled up two additional times for the qualifying visit if they do not meet the minimum symptom scores.
- Women of childbearing potential must have be negative pregnancy history at Visit 1.
Who cannot join
- Women who are pregnant or nursing.
- Subjects who have not observed the designated washout periods for any of the prohibited medications.
- Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
- Subjects with current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
- Subjects with rhinitis medicamentosa.
- Subjects who have had an upper respiratory tract or sinus infection that required antibiotic therapy within 14 days prior to Visit 1 (Screening / Consent), or subjects who have had a viral upper respiratory infection within 7 days prior to Visit 1.
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- Subjects who have nasal structural abnormalities, including nasal polyps and marked septal deviation, that significantly interferes with nasal airflow.
- Subjects who, in the opinion of the Investigator, are dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids.
- Subjects with a history of hypersensitivity to desloratadine or any of its excipients.
- Subjects who are staff personnel directly involved with the administration of this study.
- Subjects who have any current evidence of clinically significant hematopoetic, metabolic, cardiovascular, immunologic, neurologic, hematologic, gastrointestinal, hepatic, renal, psychiatric, 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.
- Subject taking prohibited drugs listed in the study protocol are excluded from participation.
About this study
Official title: A Multi-center, Open-label, Non-comparative Study of the Relief of Nasal Symptoms and Tolerability in Subjects With Seasonal Allergic Rhinitis (SAR) Treated With Aerius.
The purpose of this study was to test the effectiveness and side effects of desloratadine (Aerius) in patients with hayfever. Patients took desloratadine once a day for 15 days. At the end of therapy, they scored how severe their hayfever symptoms were and how they responded to therapy. Side effects were recorded.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- desloratadine
- 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.
desloratadineDrug
Also called Aerius, Clarinex, SCH 34117, descarboethoxyloratadine
Aerius (desloratadine) tablets; 5mg orally once a day in the morning for 15 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.
Relief of allergy symptoms
Measured: Baseline and end of therapy
Secondary outcomes (2)
Global therapeutic response
Measured: End of therapy
Adverse events
Measured: Baseline and end of therapy
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 completionJun 2003
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 311 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
- NCT00805584
- Sponsor's protocol ID
- P03442
- Status last verified
- Feb 2022
- First submitted
- 5 Dec 2008
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Non-comparative Study of the Relief of Nasal Symptoms and Tolerability in Subjects With Seasonal Allergic Rhinitis (SAR) Treated With Aerius.
- ClinicalTrials.gov ID
- NCT00805584
- Acronym / sponsor ID
- P03442
- Conditions
- Rhinitis, Allergic, Seasonal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Jun 2003 (actual)
- Study completion
- Jun 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 side effects of desloratadine (Aerius) in patients with hayfever. Patients took desloratadine once a day for 15 days. At the end of therapy, they scored how severe their hayfever symptoms were and how they responded to therapy. Side effects were recorded.
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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- Subjects must be >=18 years of age, of either sex and any race.
- Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using or agree to use an acceptable method of birth control. Women who are not currently sexually active must agree and consent to use some sort of contraception should they become sexually active while participating in the study.
- Subjects must be in general good health, i.e., they must be free of any clinically significant disease (other than SAR) that would interfere with study evaluations.
- Subjects must understand and be able to adhere to the dosing and visit schedules, and agree to report concomitant medications and adverse events to the Investigator or designee.
Key exclusion criteria (12 listed)
- Women who are pregnant or nursing.
- Subjects who have not observed the designated washout periods for any of the prohibited medications.
- Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
- Subjects with current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
- Subjects with rhinitis medicamentosa.
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: Aerius, Clarinex, SCH 34117, descarboethoxyloratadineAerius (desloratadine) tablets; 5mg orally once a day in the morning for 15 days | Drug | Arm 1 |
Primary outcome
Relief of allergy symptoms
Time frame: Baseline and end of therapy
2 secondary outcomes
Global therapeutic response
Time frame: End of therapy
Adverse events
Time frame: Baseline and end of therapy
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 17 Feb 2022.
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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 desloratadine in people with Rhinitis, Allergic, Seasonal, 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 8 inclusion and 12 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 17 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 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?
Relief of allergy symptoms (time frame: Baseline and end of therapy). 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 17 Feb 2022.