Perennial Allergic RhinitisPhase 3NCT00974571
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
A Phase 3 study testing montelukast sodium and Comparator: cetirizine in people with Perennial Allergic Rhinitis, run by Organon and Co.
Trial summary
This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- montelukast sodium and Comparator: cetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,365 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to May 2002
- 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
- Patient has a documented clinical history of perennial allergic rhinitis
- Patient is a nonsmoker
- Patient is in good general health
Who cannot join
- Patient is hospitalized
- Patient is a woman who is <8 weeks postpartum or is breast-feeding
- Patient is a current or past abuser of alcohol or illicit drugs
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
This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- montelukast sodium, Comparator: cetirizine, 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.
montelukast sodiumDrug
montelukast 10 mg tablet orally once daily at bedtime for 6 weeks
Comparator: cetirizineDrug
cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks
Comparator: placeboDrug
placebo tablet orally once daily at bedtime for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | montelukast Receives: Drug: montelukast sodium |
| 2 | Active comparator | cetirizine Receives: Drug: Comparator: cetirizine |
| 3 | 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
Mean change from baseline in Daytime Nasal Symptoms score.
Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score.
Measured: Baseline and first 4 weeks of a 6-week treatment period
Secondary outcomes (4)
Mean Change From Baseline in Nighttime Symptoms Score
Mean change from baseline in Nighttime Symptoms Score.
Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score.
Measured: Baseline and first 4 weeks in 6-week treatment period
Mean Change From Baseline in Composite Symptoms Score
Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)].
Measured: Baseline and first 4 weeks in 6-week treatment period
Patient's Global Evaluation of Allergic Rhinitis
An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
Measured: End of the first 4 weeks in 6-week treatment period
Physician's Global Evaluation of Allergic Rhinitis
An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study.
Measured: End of the first 4 weeks in 6-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startNov 2001
- Primary completionMay 2002
- Study completionMay 2002
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 Perennial Allergic RhinitisStudies 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
- 1,365 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
- NCT00974571
- Sponsor's protocol ID
- 0476-246
- Other IDs
- MK0476-246, 2009_659
- Status last verified
- Feb 2022
- First submitted
- 9 Sep 2009
- Last updated
- 3 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Philip G, Williams-Herman D, Patel P, Weinstein SF, Alon A, Gilles L, Tozzi CA, Dass SB, Reiss TF. Efficacy of montelukast for treating perennial allergic rhinitis. Allergy Asthma Proc. 2007 May-Jun;28(3):296-304. doi: 10.2500/aap.2007.28.3000.
PubMed 17619558