Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145) - Full Text View

Purpose

The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide	Phase III

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Ciclesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Comparison of the Efficacy and Safety of 160 Mcg Ciclesonide Administered Once Daily in the Evening With or Without Different Spacer Types in Patients With Asthma

Further study details as provided by ALTANA Pharma:

Primary Outcome Measures:

FEV1.

Secondary Outcome Measures:

FVC
morning and evening PEF from diaries
asthma symptom score
use of rescue medication
number of patients with an asthma exacerbation
time to the first asthma exacerbation
percentage of days on which patient perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
adverse events
physical examination
vital signs
standard laboratory work-up
8 am serum cortisol.

Estimated Enrollment:	450
Study Start Date:	September 2005

Eligibility

Ages Eligible for Study:	12 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

Written informed consent
History of persistent bronchial asthma for at least 6 months
Good health with the exception of asthma

Main Exclusion Criteria:

Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Smoking history with ≥10 cigarette pack years
Pregnancy
Intention to become pregnant
Breast feeding
Lack of safe contraception
Previous enrolment into the current study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163436

Show 66 Study Locations

Sponsors and Collaborators

ALTANA Pharma

Investigators


Principal Investigator:	Ekkehard Beck, Dr	IFG-Institut für Gesundheitsförderung GmbH, Rüdersdorf, Germany

More Information

Study ID Numbers:	BY9010/M1-145
First Received:	September 12, 2005
Last Updated:	July 16, 2008
ClinicalTrials.gov Identifier:	NCT00163436
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by ALTANA Pharma:

Asthma

Ciclesonide

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Ciclesonide

Lung Diseases

Hypersensitivity, Immediate

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases

Bronchial Diseases

Therapeutic Uses

Anti-Allergic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

Sponsored by:	ALTANA Pharma
Information provided by:	ALTANA Pharma
ClinicalTrials.gov Identifier:	NCT00163436