- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00163371
Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)
November 30, 2016 updated by: AstraZeneca
Effect of Ciclesonide (320 mcg/Day) vs Fluticasone Propionate (375 mcg/Day) vs. Placebo on Short-term Linear Growth Rate and HPA-axis Function in Prepubertal Children With Mild Asthma
The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lower leg growth in prepubertal children with mild persistent asthma.
The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 weeks).
The study will provide further data on safety and tolerability of ciclesonide.
Study Overview
Study Type
Interventional
Enrollment
28
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kolding, Denmark, 6000
- Altana Pharma/Nycomed
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main Inclusion Criteria:
- Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable
- Prepubertal stage
- Good health with the exception of asthma
- History of asthma for at least 6 months
- Currently using rescue medication only
Main Exclusion Criteria:
- Childbearing potential (beyond menarche)
- Concurrent diseases or conditions which may subsequently affect growth
- COPD or relevant lung diseases causing alternating impairment in lung function
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- History of life-threatening asthma
- Current smoking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
growth velocity of the right lower leg as measured by knemometry.
|
Secondary Outcome Measures
Outcome Measure |
---|
adverse events
|
HPA-axis function
|
weight and height
|
lung function from spirometry
|
asthma symptom score, use of rescue medication from diary
|
vital signs, including blood pressure, pulse rate
|
physical examination
|
laboratory investigation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
December 1, 2016
Last Update Submitted That Met QC Criteria
November 30, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Allergic Agents
- Ciclesonide
Other Study ID Numbers
- BY9010/M1-208
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on Ciclesonide
-
University of ChicagoSunovionWithdrawnAllergic RhinitisUnited States
-
Hamilton Health Sciences CorporationTakeda; Kolding SygehusCompleted
-
SunovionCompleted
-
SunovionCompletedSeasonal Allergic RhinitisUnited States
-
SunovionCompletedAllergic Rhinitis | Perennial Allergic RhinitisUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States
-
SunovionCompleted
-
SunovionCompletedSeasonal Allergic RhinitisUnited States
-
SunovionCompletedPerennial Allergic Rhinitis | PARUnited States
-
Allergy & Asthma Medical Group & Research CenterCompleted