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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546520
• Other study ID #: BY9010/M1-125
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2007
• Last updated: December 5, 2016
• Start date: April 2002
• Est. completion date: June 2002

Study information

• Verified date: December 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2002
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide

Locations

Country	Name	City	State
United Kingdom	"Altana Pharma/Nycomed"	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PC20FEV1 (AMP)
Secondary	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