Allergic Airway DiseasePhase 4NCT00779636
Effectiveness and Safety of Desloratadine in Patients With Allergic Airway Disease During the Pollen Season (Study P03284)
A Phase 4 study testing Desloratadine in people with Allergic Airway Disease, run by Organon and Co.
Trial summary
This was a placebo controlled study designed to evaluate the effectiveness of desloratadine in relieving symptoms of allergic airway disease during the pollen season. Patients received desloratadine 10 mg or placebo once daily for 28 days, and had their allergy symptoms and side effects to medication measured on Day… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Airway Disease
- What is being tested?
- Desloratadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 506 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2003to 1 Nov 2004
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 65 years old
- at least a two-year history of seasonal allergic rhinitis and the presence of chest symptoms (cough, wheezing, difficulty breathing) associated with the allergy season
- FEV1 was greater than or equal to 70% of predicted
- skin test positive (skin prick test)
- Total Nasal Symptom Severity Score of >= 6 at the Screening Visit.
- Total Chest Symptom Severity Score of >= 3 at the Screening Visit.
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- Total Frequency of Chest Symptoms and/or Total Frequency of Bronchodilator Use of at least 2 at the Screening Visit
- Total Nasal Symptom Severity Score was >= 6 on 7 of the 15 run-in diary timepoints.
- Total Chest Symptom Severity Score was >= 3 on 7 of the 15 run-in diary timepoints
- Free of any clinically significant disease that would interfere with the study evaluations.
Who cannot join
- Subjects who:
- demonstrated a change in FEV1 of >= 20% between Visit 2 and Visit 3.
- used >12 puffs of Proventil® HFA (or other beta-2-agonist) on any 2 consecutive days or treatment with nebulized beta-2 agonists during the screening period - between Visit 2 and Visit 3.
- required chronic use of inhaled or systemic corticosteroids.
- required regular treatment with nebulized beta2-agonists.
- required short acting beta-2 agonists use before every exercise session or exposure to an animal.
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- have current or history of frequent (2 or more episodes per year for the past 2 years), clinically significant sinusitis or chronic purulent postnasal drip.
- have rhinitis medicamentosa or chronic obstructive pulmonary disease (COPD).
- had an upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose 14 days prior to Screening, or who have had a upper or lower viral respiratory infection within 7 days prior to Screening.
- had nasal structural abnormalities, including large nasal polyps and marked septal deviation that significantly interfered with nasal air flow.
- in the opinion of the Investigator, were dependent upon nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids.
- are on immunotherapy (desensitization therapy), unless on a regular maintenance schedule prior to the Screening visit and staying on this schedule for the remainder of the study. Subjects could not receive desensitization treatment within 24 hours prior to a study visit.
- smoke, or ex-smokers who had smoked within the previous six months.
- had current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subject's participation in the study or with the subject's ability to complete the diary cards.
- were morbidly obese (BMI >= 35).
- were night-shift workers and those who did not have a standard asleep at night / awake during the day cycle.
- had any history of life threatening asthma attacks or subjects who had been treated in the emergency room or been admitted to the hospital for asthma control within the previous 3 months or more than once in the previous 6 months.
About this study
Official title: Efficacy and Safety of Desloratadine 10 mg Daily vs. Placebo in Subjects With Allergic Airway Disease During the Pollen Season
This was a placebo controlled study designed to evaluate the effectiveness of desloratadine in relieving symptoms of allergic airway disease during the pollen season. Patients received desloratadine 10 mg or placebo once daily for 28 days, and had their allergy symptoms and side effects to medication measured on Day 1, Day 15, and Day 29 (one day after stopping study drug).
- Conditions
- Allergic Airway Disease
- Being tested
- Desloratadine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesloratadineDrug
Also called Clarinex, SCH 034117
Desloratadine 10 mg daily x 28 days
PlaceboDrug
Placebo daily x 28 days
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine 10 mg | Experimental | Not described Receives: Drug: Desloratadine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 averaged over weeks 1 to 4.
Measured: Over weeks 1 to 4
Secondary outcomes (9)
Change from Baseline in chest symptoms, nasal symptoms, and eye symptom scores
Measured: Day 15 and Day 29
Interference with sleep and daily activities
Measured: Day 15 and Day 29
Number of nocturnal awakenings due to chest symptoms
Measured: Day 15 and Day 29
Overall Therapeutic Response to therapy of allergic airway disease symptoms (investigator and joint evaluation)
Measured: Day 15 and Day 29
Change from Baseline in chest symptoms, nasal symptoms, and eye symptom scores
Measured: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29)
Change in FEV1, FVC, FEF(25%-75%), PEFR
Measured: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29)
Use of Proventil® HFA rescue medication
Measured: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29)
Interference with sleep and daily activities
Measured: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29)
Number of nocturnal awakenings due to chest symptoms
Measured: ALL TREATMENT VISITS (Day 1, 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 posted24 Oct 2008 (estimated)
- Study start1 Jul 2003
- Primary completion1 Nov 2004
- Study completion1 Nov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Airway DiseaseStudies 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
- 506 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
- NCT00779636
- Sponsor's protocol ID
- P03284
- Status last verified
- Feb 2022
- First submitted
- 23 Oct 2008
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Desloratadine 10 mg Daily vs. Placebo in Subjects With Allergic Airway Disease During the Pollen Season
- ClinicalTrials.gov ID
- NCT00779636
- Acronym / sponsor ID
- P03284
- Conditions
- Allergic Airway Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2003 (actual)
- Primary completion
- 1 Nov 2004 (actual)
- Study completion
- 1 Nov 2004 (actual)
- First posted
- 24 Oct 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.
This was a placebo controlled study designed to evaluate the effectiveness of desloratadine in relieving symptoms of allergic airway disease during the pollen season. Patients received desloratadine 10 mg or placebo once daily for 28 days, and had their allergy symptoms and side effects to medication measured on Day 1, Day 15, and Day 29 (one day after stopping study drug).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desloratadine 10 mg | Experimental | Drug: Desloratadine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 - 65 years old
- at least a two-year history of seasonal allergic rhinitis and the presence of chest symptoms (cough, wheezing, difficulty breathing) associated with the allergy season
- FEV1 was greater than or equal to 70% of predicted
- skin test positive (skin prick test)
- Total Nasal Symptom Severity Score of >= 6 at the Screening Visit.
Key exclusion criteria (17 listed)
- demonstrated a change in FEV1 of >= 20% between Visit 2 and Visit 3.
- used >12 puffs of Proventil® HFA (or other beta-2-agonist) on any 2 consecutive days or treatment with nebulized beta-2 agonists during the screening period - between Visit 2 and Visit 3.
- required chronic use of inhaled or systemic corticosteroids.
- required regular treatment with nebulized beta2-agonists.
- required short acting beta-2 agonists use before every exercise session or exposure to an animal.
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, SCH 034117Desloratadine 10 mg daily x 28 days | Drug | Desloratadine 10 mg |
| PlaceboPlacebo daily x 28 days | Drug | Placebo |
Primary outcome
Change in FEV1 averaged over weeks 1 to 4.
Time frame: Over weeks 1 to 4
9 secondary outcomes
Change from Baseline in chest symptoms, nasal symptoms, and eye symptom scores
Time frame: Day 15 and Day 29
Interference with sleep and daily activities
Time frame: Day 15 and Day 29
Number of nocturnal awakenings due to chest symptoms
Time frame: Day 15 and Day 29
Overall Therapeutic Response to therapy of allergic airway disease symptoms (investigator and joint evaluation)
Time frame: Day 15 and Day 29
Change from Baseline in chest symptoms, nasal symptoms, and eye symptom scores
Time frame: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29)
Change in FEV1, FVC, FEF(25%-75%), PEFR
Time frame: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29)
Use of Proventil® HFA rescue medication
Time frame: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29)
Interference with sleep and daily activities
Time frame: ALL TREATMENT VISITS (Day 1, Day 15, and Day 29)
Number of nocturnal awakenings due to chest symptoms
Time frame: ALL TREATMENT VISITS (Day 1, 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 15 Aug 2024.
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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 Allergic Airway Disease, 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 10 inclusion and 17 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 15 Aug 2024. 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. 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?
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?
Change in FEV1 averaged over weeks 1 to 4. (time frame: Over weeks 1 to 4). 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 15 Aug 2024.