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Completed

NCT Number: NCT00305487

Safety and Efficacy of Ciclesonide in Pediatric Patients (6 to 11 Years of Age) With Seasonal Allergic Rhinitis (BY9010/M1-417)

The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).

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Key information

Conditions

Hay Fever Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Seasonal Allergic Rhinitis

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Written informed consent
  • General good health other than seasonal allergic rhinitis
  • Positive standard skin prick test

Main Exclusion Criteria:

  • Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit
  • A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
  • Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
  • Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
  • Use of any prohibited concomitant medications
  • Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
  • Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
  • Study participation by more than one patient from the same household

Treatment and study plan

Ciclesonide Nasal Spray

Drug

Primary outcomes

  1. Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment

Secondary outcomes

  1. Physician assessment of nasal symptoms score at endpoint

  2. average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment

  3. safety

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Mar 22, 2006
Registry last updated
Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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