Rhinitis, Allergic, PerennialPhase 3NCT00092118
The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)
A Phase 3 study testing Montelukast in people with Rhinitis, Allergic, Perennial, run by Organon and Co.
Trial summary
The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic… Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,992 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to May 2004
- Phase
- Phase 3
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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing
Who cannot join
- Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
About this study
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Montelukast, Comparator: Placebo
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
one 10 mg tablet, taken once daily at bed time for 6 weeks
Comparator: PlaceboDrug
one placebo tablet, taken once daily at bed time for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Montelukast Receives: Drug: Montelukast |
| 2 | Placebo comparator | Placebo Receives: Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis
Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)].
Measured: 6 week treatment period (from baseline though the end of week 6)
Secondary outcomes (2)
Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period
An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study.
Measured: At the end of the 6 week treatment period
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period
Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2004 (estimated)
- Study startOct 2003
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, PerennialStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,992 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00092118
- Sponsor's protocol ID
- 0476-265
- Other IDs
- MK0476-265, 2004_018
- Status last verified
- Feb 2022
- First submitted
- 21 Sep 2004
- Last updated
- 3 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Patel P, Philip G, Yang W, Call R, Horak F, LaForce C, Gilles L, Garrett GC, Dass SB, Knorr BA, Reiss TF. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2005 Dec;95(6):551-7. doi: 10.1016/S1081-1206(10)61018-6.
PubMed 16400895