---
title: Assess the Efficacy and Safety of Rhinocort Aqua
nct_id: NCT00641693
overall_status: COMPLETED
phase: PHASE2
sponsor: AstraZeneca
study_type: INTERVENTIONAL
primary_condition: Allergic Rhinitis
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00641693.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00641693"
ct_last_update_post_date: 2011-01-24
last_seen_at: "2026-05-12T07:26:25.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Assess the Efficacy and Safety of Rhinocort Aqua

**Official Title:** A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Phase II Study to Assess the Efficacy and Safety of RHINOCORT AQUA (Budesonide) Nasal Spray 16mg, 32mg and 64mg Per Day Versus Placebo in Paediatric Subjects Ages 2-5 Years Old With Allergic Rhinitis.

**NCT ID:** [NCT00641693](https://clinicaltrials.gov/study/NCT00641693)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 650
- **Lead Sponsor:** AstraZeneca
- **Conditions:** Allergic Rhinitis
- **Start Date:** 2004-04
- **Completion Date:** 2005-05
- **CT.gov Last Update:** 2011-01-24

## Brief Summary

The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.

## Eligibility

- **Minimum age:** 2 Years
- **Maximum age:** 5 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
* A documented history of allergic rhinitis and a positive response to a skin prick test at Visit 1 or within the last 12 months for allergens that must be present in the subject's environment for the duration of the study.
* At randomisation having nasal symptom scores as defined by the protocol.

Exclusion Criteria:

* Primary or secondary adrenal insufficiency
* Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
* A diagnosis of asthma requiring treatment as specifies in the protocol.
```

## Arms

- **1** (EXPERIMENTAL) — Nasal Spray
- **2** (PLACEBO_COMPARATOR)

## Interventions

- **Budesonide** (DRUG) — 16mg Nasal Spray
- **Budesonide** (DRUG) — 32mg Nasal Spray
- **Budesonide** (DRUG) — 64mg Nasal Spray
- **Placebo** (DRUG)

## Primary Outcomes

- **To compare Rhinocort with placebo to compare effects on nasal symptoms such as sneezing, runny and stuffy noses as assessed by caregivers.** _(time frame: At 2 weeks)_

## Secondary Outcomes

- **Safety assessment via adverse events and clinical measurements** _(time frame: At 1 & 2 weeks)_
- **To assess efficacy of Rhinocort via the physician and caregivers assessments** _(time frame: At 2 weeks)_

## Recent Field Changes (last 30 days)

- `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)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — 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/NCT00641693.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00641693*  
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