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

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ClinicalTrials.gov Identifier: NCT00608218
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment
Asthma Drug: Ciclesonide

Study Type : Observational
Estimated Enrollment : 2100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ciclesonide for the Therapy of Asthma During the Cold Season.
Study Start Date : January 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide

Group/Cohort Intervention/treatment
Artist Drug: Ciclesonide
This is an observational study. Therefore, the physician decides about dosage according to individual needs.




Primary Outcome Measures :
  1. FEV1, symptom score assessment [ Time Frame: within 3 months ]

Secondary Outcome Measures :
  1. Handling of the metered-dose inhaler, safety and tolerability [ Time Frame: within 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608218


  Show 153 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00608218     History of Changes
Other Study ID Numbers: Alves Artist 07/10
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: September 2016

Keywords provided by AstraZeneca:
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents