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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Ciclesonide
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014