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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00608218
First received: January 23, 2008
Last updated: May 4, 2012
Last verified: May 2012
  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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ciclesonide for the Therapy of Asthma During the Cold Season.

Resource links provided by NLM:


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 ]

Estimated Enrollment: 2100
Study Start Date: January 2008
Study Completion Date: August 2008
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

  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

No publications provided

ClinicalTrials.gov Identifier: NCT00608218     History of Changes
Other Study ID Numbers: Alves Artist 07/10
Study First Received: January 23, 2008
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:
Asthma
ciclesonide
inhaled steroids
Alvesco

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014