Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma - Full Text View

Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma (ARTIST)

This study is currently recruiting participants.
Verified by Nycomed, October 2008

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00608218

Purpose

The aim of the study is to evaluate the efficacy of ciclesonide in patients with persistent asthma over 3 months, especially in the cold season. Ciclesonide will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of ciclesonide.

Condition	Intervention
Asthma	Drug: Ciclesonide

MedlinePlus related topics:

Asthma

Drug Information available for:

Ciclesonide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

Official Title:	Ciclesonide for the Therapy of Asthma During the Cold Season.

Further study details as provided by Nycomed:

Primary Outcome Measures:

FEV1, symptom score assessment [ Time Frame: within 3 months ]

Secondary Outcome Measures:

Handling of the metered-dose inhaler, safety and tolerability [ Time Frame: within 3 months ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	2100
Study Start Date:	January 2008
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Artist	Drug: Ciclesonide This is an observational study. Therefore, the physician decides about dosage according to individual needs.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Outpatients

Criteria

Main inclusion criteria:

History of persistent bronchial asthma

Main exclusion criteria:

Hypersensitive to compounds of Alvesco
Other criteria as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.3)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608218

Contacts


Contact: Nycomed Info		info@nycomed.com

Show 153 Study Locations

Sponsors and Collaborators

Nycomed

Investigators


Study Director:	Dr. Thomas D. Bethke, PhD, MD	Nycomed Deutschland GmbH, 78467 Konstanz, Germany

More Information

Study ID Numbers:	Alves Artist 07/10
First Received:	January 23, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00608218
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:

Asthma

ciclesonide

inhaled steroids

Alvesco

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 November 03, 2008