---
title: Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)
nct_id: NCT00092144
overall_status: COMPLETED
phase: PHASE3
sponsor: Organon and Co
study_type: INTERVENTIONAL
primary_condition: Asthma
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00092144.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00092144"
ct_last_update_post_date: 2024-08-15
last_seen_at: "2026-05-12T07:22:41.013Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)

**Official Title:** A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral MK0476 Vs Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season

**NCT ID:** [NCT00092144](https://clinicaltrials.gov/study/NCT00092144)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 500
- **Lead Sponsor:** Organon and Co
- **Conditions:** Asthma
- **Start Date:** 2004-02-26
- **Completion Date:** 2004-06-15
- **CT.gov Last Update:** 2024-08-15

## Brief Summary

The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Asthma symptoms brought on by allergies

Exclusion Criteria:

* Patient has any lung disease
* Currently have a sinus infection or cold symptoms
```

## Interventions

- **MK0476, montelukast sodium / Duration of Treatment: 4 weeks** (DRUG)
- **Comparator: placebo / Duration of Treatment: 4 weeks** (DRUG)

## Primary Outcomes

- **To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period**

## Secondary Outcomes

- **To assess the following over a 3-week treatment period:**
- **nighttime symptoms**
- **AM PEFR**
- **PM PEFR**
- **B-agonist use**
- **asthma attacks**
- **discontinuations due to asthma**

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00092144.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00092144*  
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