This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: October 18, 2007
Last updated: December 5, 2016
Last verified: December 2016
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 Intervention Phase
Asthma Drug: Ciclesonide Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PC20FEV1 (AMP)

Secondary Outcome Measures:
  • 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

Enrollment: 21
Study Start Date: April 2002
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)

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
  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 identifier: NCT00546520

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

Responsible Party: AstraZeneca Identifier: NCT00546520     History of Changes
Other Study ID Numbers: BY9010/M1-125
Study First Received: October 18, 2007
Last Updated: December 5, 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 processed this record on September 21, 2017