Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)

Asthma Clinical Trial

Official title:

Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 mcg Once Daily) Versus Placebo in Patients With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163345
• Other study ID #: BY9010/M1-131
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: December 7, 2016
• Start date: September 2003
• Est. completion date: May 2006

Study information

• Verified date: December 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, CT-scanning, and cellular markers of inflammation. Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Main Inclusion Criteria:

• Written informed consent

• History of bronchial asthma

• FEV1 more than or equal to 60% of predicted

• Stable asthma

• Patients who are in good health with the exception of asthma

Main Exclusion Criteria:

• Concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ICS

• COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function

• Use of ICS 4 weeks before entry into the baseline period

• Pregnancy

• Intention to become pregnant during the course of the study

• Breast feeding

• Lack of safe contraception

• Use of other drugs not allowed

• Current smokers and ex-smokers with more than or equal to 10 pack-years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Ciclesonide

Locations

Country	Name	City	State
Netherlands	Altana Pharma/Nycomed	RB Groningen

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh
Primary	FVC% at PC20 AMP, SVC% at PC20 AMP
Primary	regional air trapping
Primary	bronchial and alveolar exhaled NO
Primary	lung function variables
Primary	non-cellular inflammatory markers.
Secondary	safety and tolerability.

External Links

•   BY9010_M1-131 Synopsis