To assess the safety of Ciclesonide, applied as a nasal spray at three dose levels, in the treatment of perennial allergic rhinitis in pediatrics (BY9010/M1-405)

Study identifier:BY9010/M1-405

ClinicalTrials.gov identifier:NCT00658918

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A randomized, double-blind, placebo-controlled, parallel-group, clinical trial designed to assess the safety of ciclesonide, applied as a nasal spray at three dose levels, 200µg, 100µg or 25µg once daily for six weeks, in the treatment of perennial allergic rhinitis (PAR) in pediatric patients 2-5 years of age.

Medical condition

Rhinitis, Allergic, perennial

Phase

Phase 3

Healthy volunteers

Study drug

Ciclesonide nasal, Placebo

Sex

All

Actual Enrollment

120

Study type

Interventional

Age

2 Years - 5 Years

Date

Study Start Date: 01 Sept 2004

Primary Completion Date: 01 Apr 2005

Study Completion Date: 01 Nov 2005

Study design

Allocation: Randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2016 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

1. Male or female between the ages of 2 and 5 years, inclusive
2. General good health, and free of any concomitant conditions or treatment
that could interfere with study conduct, influence the interpretation
of study observations/results, or put the patient at increased risk during
the trial
3. A demonstrated sensitivity to at least one allergen known to induce
PAR through a standard prick skin test within one year of study start. A
positive test is defined as a wheal diameter at least 3mm larger than the
control wheal for th eprick test
4. Parent or legal guardian is capable of understanding the requirements,
risks, and benefits of study participation, and, as judged by the
investigator, capable of giving informed consent and comply with all study
requirements (visits, record-keeping, etc.)
5. A history of PAR for a minimum of 3 months preceding the study screening
visit (B0). The PAR must have been of sufficient severity to require
treatment (either continuous or intermittent) in the past and in the
investigators judgment is expected to continue to require treatment for the
study duration.

Exclusion Criteria

1. History of physical findings of nasal pathology, including nasal polyps
(within the last 60 days) or other clinically significant respiratory tract
malformations, recent nasal biopsy (within the last 60 days), nasal trauma,
or surgery and atrophic rhinitis or rhinitis medicamentosa (within the last
60 days).
2. Participation in any investigational drug trial within the 30 days preceding
the Screening Visit (B0) or at any time during the trial
3. A known hypersensitivity to any corticosteroid or any of the excipients in
the formulation.
4. History of a respiratory infection or disorder [including, but not limited
to bronchitis, pneumonia, the common cold, acute or chronic sinusitis, flu,
severe acute respiratory syndrome (SARS)] within the 14 days preceding the
Screening Visit, or development of a respiratory infection during the
Screening Visit (B0)
5. History of a positive test for HIV, hepatitis B or hepatitis C.
6. Active asthma requiring treatment with inhaled or systemic corticosteroids
and/or routine use of b-agonists and any controller drugs (e.g.
theophylline, leukotrienes, etc.) intermittent use of b-agonists is
acceptable
7. Use of any prohibited concomitant medications within the prescribed (per
protocol) withdrawal periods prior to the screening visit (B0) and during
the entire screening period and treatment duration
8. Use of antibiotic therapy for acute conditions within 14 days prior to the
Screening Visit (B0).
9. Initiation of immunotherapy during the study period or dose escalation
during the study period. However, initiation of immunotherapy 90 days or
more prior to the Screening Visit AND use of a stable (maintenance) dose (30
days or more) may be considered for inclusion.
10. Non-vaccinated exposure to, or infection with, chickenpox or measles
within the 21 days preceding the Screening Visit (B0).
11. Exposure to systemic corticosteroids for any indication, chronic or
intermittent (e.g.: contact dermatitis), during the past 2 months, or
presence of an underlying condition that can reasonably be expected to
require treatment with corticosteroids during the course of the study.
12. Use of topical corticosteroids in concentrations in excess of 1%
hydrocortisone for dermatological conditions during the past 1 month, or
presence of an underlying condition that can reasonably be expected to
require treatment with such preparations during the course of the study.
13.Intraocular pressure at the screening visit (B0) of 21 mm Hg or greater or
failed reading at the screening Visit (B0)
14. Glaucoma requiring treatment
15. Use of antiepileptic drugs for epilepsy within 30 days of the screening
visit (B0) or anytime during the treatment period.
16. Initiation of pimecrolimus 1% cream or tacrolimus ointment 0.1% or 0.03% during the study period or planned dose escalation during the study period. However, initiation of these creams/ointments 30 days or more prior to the screening Visit (B0) AND use of a stable (maintenance) dose during the study period may be considered for inclusion

No locations available

Arms	Assigned Interventions
Active Comparator: 1 Ciclesonide 200µg	Drug: Ciclesonide nasal safety of Ciclesonide (200µg, 100µg, 25µg)
Active Comparator: 2 Ciclesonide 100µg	Drug: Ciclesonide nasal safety of Ciclesonide (200µg, 100µg, 25µg)
Active Comparator: 3 Ciclesonide 25µg	Drug: Ciclesonide nasal safety of Ciclesonide (200µg, 100µg, 25µg)
Placebo Comparator: 4 Placebo	Drug: Placebo placebo

Documents available

BY9010-M1-405-RDS-2005-11-07.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

AstraZeneca AstraZeneca

AstraZeneca