Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00546520
Recruitment Status : Completed
First Posted : October 19, 2007
Last Update Posted : December 7, 2016
Information provided by (Responsible Party):

Brief Summary:
Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and induced sputum inflammatory biomarkers will be evaluated.

Condition or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A 3-period Double-blind, Cross-over Study on the Onset of Action of Inhaled Ciclesonide (7 Days of 400 mcg Sid Versus 800 mcg Bid Versus Placebo) on Airway Responsiveness to Adenosine Monophosphate (AMP), Sputum Eosinophiles and Exhaled Breath Nitric Oxide (NO) in Patients With Asthma
Study Start Date : April 2002
Actual Primary Completion Date : June 2002
Actual Study Completion Date : June 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Ciclesonide
U.S. FDA Resources

Primary Outcome Measures :
  1. PC20FEV1 (AMP)

Secondary Outcome Measures :
  1. Baseline FEV1 from spirometry, exhaled NO, eosinophils, basophils, and mast cells determined from induced sputum; Safety variables: Physical examination, vital signs, ECG, laboratory work-up, and adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main inclusion criteria:

  • Out-patients
  • Written informed consent
  • History of atopic disease
  • History of perennial bronchial asthma for at least 6 months as defined by ATS criteria
  • Current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period B0)
  • Stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start
  • FEV1 ≥ 70% predicted
  • Hyperreactivity to AMP (PC20FEV1 < 25 mg/ml)
  • Good health with the exception of asthma
  • Non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence

Main exclusion criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis)
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
  • Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
  • Pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year
  • COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases
  • Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers
  • Immunotherapy within one month prior to B0 and/or during the entire study duration

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 identifier (NCT number): NCT00546520

United Kingdom
"Altana Pharma/Nycomed"
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Responsible Party: AstraZeneca Identifier: NCT00546520     History of Changes
Other Study ID Numbers: BY9010/M1-125
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016

Keywords provided by AstraZeneca:
Airway hyperresponsiveness
Nitric oxide

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Allergic Agents