Ciclesonide for the Treatment of Airway Hyperresponsiveness (BY9010/CH-101)
Information source: Nycomed
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Ciclesonide (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Nycomed Official(s) and/or principal investigator(s):
Nycomed Clinical Trial Management, Study Chair, Affiliation: Headquarter
Overall contact:
Nycomed Clinical Trial Management, Phone: +497531840, Email: clinicaltrials@nycomed.com
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 administered as follows: 320 microgram
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.
Clinical Details
Official title: Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-Blind, Randomized, Parallel Group Study.
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo
Secondary outcome: RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given)Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment Level of exhaled nitric oxide after 4 weeks of treatment mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper) Mean change of ACQ after 4 weeks of treatment Mean change of AQLQ after 4 weeks of treatment Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment Exacerbation rates during the 4 weeks of treatment
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.
2. Asthma symptoms partly controlled according to GINA (October 2006) 1 week prior to
randomization
3. FEV1 ≥ 70% predicted
4. 18 - 70 years old
Exclusion Criteria:
1. Smoker and ex-smoker with >10 pack years
2. COPD
3. Upper respiratory tract infection within the past 4 weeks.
4. ICS or oral steroids during the previous month before inclusion
5. b-blockers within the past 4 weeks
6. Current treatment with medication as defined in section concomitant medication (ICS
other than study medication, ß-blockers)
7. Pregnancy
8. Known malignancy
Locations and Contacts
Nycomed Clinical Trial Management, Phone: +497531840, Email: clinicaltrials@nycomed.com
Nycomed, Basel 4031, Switzerland; Recruiting
Nycomed Clinical Trial Management, Email: clinicaltrials@nycomed.com
Additional Information
Starting date: September 2008
Ending date: October 2009
Last updated: July 3, 2009
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