Ciclesonide for the Treatment of Airway Hyperresponsiveness (BY9010/CH-101) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 21, 2009

Last Updated Date

January 21, 2009

Start Date ^†

September 2008

Current Primary Outcome Measures ^†

Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Level of exhaled nitric oxide after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean change of ACQ after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean change of AQLQ after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Exacerbation rates during the 4 weeks of treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Ciclesonide for the Treatment of Airway Hyperresponsiveness (BY9010/CH-101)

Official Title ^†

Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-Blind, Randomized, Parallel Group Study.

Brief Summary

The study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having PD15 mannitol. Treatment medication will be adminstered as follows: 320 mikrogramm ciclesonide or placebo will be inhaled once daily. The study duration consists of a treatment period of 4 weeks. The study will provide further data on safety of ciclesonide.

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Asthma

Intervention ^†

Drug: Ciclesonide
Drug: Placebo

Study Arms / Comparison Groups

Active Comparator: Ciclesonide 320µg
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

100

Estimated Completion Date

October 2009

Estimated Primary Completion Date

August 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness.
Asthma symptoms partly controlled according to GINA (October 2006) 1 week prior to randomization
FEV1 ≥ 70% predicted
18 - 70 years old

Exclusion Criteria:

Smoker and ex-smoker with >10 pack years
COPD
Upper respiratory tract infection within the past 4 weeks.
ICS or oral steroids during the previous month before inclusion
b-blockers within the past 4 weeks
Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers)
Pregnancy
Known malignancy

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Nycomed Clinical Trial Management

+497531840

clinicaltrials@nycomed.com

Location Countries ^†

Switzerland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00826969

Responsible Party

Nycomed, Nycomed

Secondary IDs ^††

Study Sponsor ^†

Nycomed

Collaborators ^††

Investigators ^†

Study Chair:

Nycomed Clinical Trial Management

Headquarter

Information Provided By

Nycomed

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.