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

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00826969

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Ciclesonide Drug: Placebo	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Ciclesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-Blind, Randomized, Parallel Group Study.

Further study details as provided by Nycomed:

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 ]

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 ]

Estimated Enrollment:	100
Study Start Date:	September 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Ciclesonide 320µg	Drug: Ciclesonide 320µg Ciclesonide versus Placebo
2: Placebo Comparator Placebo	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826969

Contacts

Contact: Nycomed Clinical Trial Management

+497531840

clinicaltrials@nycomed.com

Locations

Switzerland
Nycomed	Recruiting
Basel, Switzerland, 4031
Contact: Nycomed Clinical Trial Management clinicaltrials@nycomed.com

Sponsors and Collaborators

Nycomed

Investigators

Study Chair:

Nycomed Clinical Trial Management

Headquarter

More Information

No publications provided

Responsible Party:	Nycomed ( Nycomed )
Study ID Numbers:	BY9010/CH-101
Study First Received:	January 21, 2009
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00826969 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by Nycomed:

Asthma
Ciclesonide

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Mannitol
Ciclesonide

Lung Diseases
Hypersensitivity, Immediate
Asthma
Anti-Allergic Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Bronchial Diseases
Immune System Diseases
Ciclesonide
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive

Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 06, 2009