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Allergic RhinitisPhase 3NCT00405964

Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684)

A Phase 3 study testing 5-mg Desloratadine in people with Allergic Rhinitis, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis who meet the criteria for persistent allergic rhinitis (PER) Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Allergic Rhinitis
What is being tested?
5-mg Desloratadine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
716 participants
Where
No sites listed yet
Study dates
Sep 2006to Apr 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • For this study, the diagnosis of persistent allergic rhinitis (PER) is not based solely on the current episode of allergic rhinitis (AR). Subjects must have at least a 2 year history of AR consistent with PER (defined as symptoms of allergic rhinitis present more than four days per week and for more than four consecutive weeks per year); the current episode can count as the second year.
  • Subjects must be 12 years of age and older, of either sex and of any race.
  • At the Run-in Visit, subjects must be sufficiently symptomatic, with a T5SS 12-hour AM-PRIOR (Subject's Status Over Previous 12 Hours) symptoms severity score of at least 8.
  • In order for a subject to qualify at the Baseline Visit, the sum of the daily averages of the diary recordings of the 12-hour AM PRIOR + PM-PRIOR T5SS collected during Days -4 to -1 and the AM PRIOR T5SS on the morning of the Baseline Visit (Day 1) must be >=40.
  • Subjects must have a positive skin-prick test at screening to one or more allergens in the Global Allergy and Asthma European Network (GA2LEN) (or the usually used local) panel of seasonal and perennial allergens. Subjects must demonstrate an antigen-induced skin prick wheal at least 3 mm in diameter greater than diluent control. The positive tests must include the allergen(s) prevalent while this study is active.
  • Subjects must be free of any clinically significant disease, other than PER, which would interfere with the study evaluations.
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  • Subjects, or parents or legal guardians, must give written informed consent. Subjects must be able to adhere to dose, visit schedules and meet study requirements.
  • In females of childbearing potential, the urine pregnancy test (human chorionic gonadotropin [hCG]) must be negative at the Screening Visit.
  • Nonsterile or premenopausal female subjects must be using a medically accepted method of birth control, that is, oral contraceptive, hormonal implant, medically prescribed intra-uterine device (IUD), or depot injectable during the entire study. A female subject who is not currently sexually active must agree and consent to use one of the above-mentioned methods, if she becomes sexually active while participating in the study. A female subject who is not of childbearing potential must have a medical record of being surgically sterile (for example, hysterectomy, and tubal ligation), or be at least 1 year postmenopausal.

Who cannot join

  • Subjects with a history of anaphylaxis and/or severe local reactions(s) to skin testing with allergens.
  • Subjects with intolerable symptoms that would make participating in the study unbearable.
  • Subjects who have had an upper respiratory tract or sinus infection that required antibiotic therapy, and have not had at least a 14-day washout prior to the run-in period, or who have had a viral upper respiratory infection within 7 days prior to screening.
  • Subjects with asthma who require chronic use of inhaled or systemic corticosteroids.
  • Subjects with a current history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
  • Subjects on immunotherapy (desensitization therapy) unless on a regular maintenance schedule prior to Visit 1 and staying on this schedule for the remainder of the study.
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  • Subjects who, in the opinion of the investigator, are dependent on nasal, oral or ocular decongestants, nasal topical antihistamines or nasal steroids.
  • Subjects who have used any drug or device in an investigational protocol in the 30 days prior to Visit 1.
  • Female subjects who are pregnant or nursing.
  • Subjects with a history of hypersensitivity to the study drug or to their excipients or known to not tolerate any antihistamine.
  • Subject is a member of the Investigational Study Staff (currently involved with this study) or a member of the staff's family.
  • Subjects with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that preclude the subject's participation in the study.
  • Subjects whose ability to provide informed consent is compromised.
  • Subjects with a history of noncompliance with medications or treatment protocols.
  • Subjects with rhinitis medicamentosa.
  • Subjects who have, in the opinion of the investigator or designee, clinically significant nasal structural abnormalities, including large nasal polyps or marked septum deviation, that significantly interferes with nasal air flow.
  • Subjects who have not observed mediation washout times prior to visit 2

About this study

Official title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter/Multinational, Efficacy and Safety Study of Desloratadine 5 mg in the Treatment of Subjects With Allergic Rhinitis Who Meet the Criteria for Persistent Allergic Rhinitis (PER)

This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis who meet the criteria for persistent allergic rhinitis (PER)

Being tested
5-mg Desloratadine, Placebo tablet
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5-mg DesloratadineDrug

    Also called SCH 34117, Aerius

    5-mg Desloratadine tablet, once daily for 12 weeks

  • Placebo tabletDrug

    Placebo tablet, once daily for 12 weeks

Study groups in NCT00405964
Study groupRoleWhat they receive
5-mg Desloratadine tabletExperimentalNot described
Receives: Drug: 5-mg Desloratadine
Placebo tabletPlacebo comparatorNot described
Receives: Drug: Placebo tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment

    AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 29. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.

    Measured: Baseline and Days 1-29

Secondary outcomes (2)

  1. Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment

    The RQLQ-S was only completed for participants above 18 years of age. The RQLQ-S was not available for participants 12 to 17 years of age. This questionnaire asked questions pertaining to daily activities, sleep, non-nose eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions. The scale went from 0 (not troubled) to 6 (extremely troubled). A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.

    Measured: Baseline and Day 29

  2. Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment

    AM/PM PRIOR (the participant's status over previous 12 hours) T5SS from the participant's daily diary averaged over treatment Days 1 to 85. AM/PM is the average of separate AM and PM evaluations. Scores were defined for T5SS as 0: no symptoms to 15: all severe symptoms. A two-way analysis of variance (ANOVA) model with treatment and site effects was used to examine the treatment difference.

    Measured: Baseline and Days 1-85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
716 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00405964
Sponsor's protocol ID
P04684
Status last verified
Feb 2022
First submitted
30 Nov 2006
Last updated
20 May 2024
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bousquet J, Bachert C, Canonica GW, Mullol J, Van Cauwenberge P, Jensen CB, Fokkens WJ, Ring J, Keith P, Gopalan G, Lorber R, Zuberbier T; ACCEPT-2 Study Group. Efficacy of desloratadine in persistent allergic rhinitis - a GA(2)LEN study. Int Arch Allergy Immunol. 2010;153(4):395-402. doi: 10.1159/000316351. Epub 2010 Jun 18.

    PubMed 20559006

  • Bousquet J, Zuberbier T, Canonica GW, Fokkens WJ, Gopalan G, Shekar T. Randomized controlled trial of desloratadine for persistent allergic rhinitis: correlations between symptom improvement and quality of life. Allergy Asthma Proc. 2013 May-Jun;34(3):274-82. doi: 10.2500/aap.2013.34.3668.

    PubMed 23676577

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5-mg Desloratadine in people with Allergic Rhinitis, 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 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 20 May 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 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?

Yes. Results are posted in the registry (first posted 19 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment (time frame: Baseline and Days 1-29). 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 NCT00405964, which also lists 2 linked publications.

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 20 May 2024.

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