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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00546520
First received: October 18, 2007
Last updated: May 4, 2012
Last verified: October 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Takeda:

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
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00546520

Locations
United Kingdom
"Altana Pharma/Nycomed"
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Takeda
Investigators
Study Director: Renate Engelstätter, PhD ALTANA Pharma, D-78467 Konstanz, Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00546520     History of Changes
Other Study ID Numbers: BY9010/M1-125
Study First Received: October 18, 2007
Last Updated: May 4, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Takeda:
Asthma
Ciclesonide
Airway hyperresponsiveness
Sputum
Nitric oxide

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 22, 2014