Ciclesonide for the Treatment of Airway Hyperresponsiveness
2 other identifiers
interventional
64
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 asthma
Started Sep 2008
Longer than P75 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 21, 2009
CompletedFirst Posted
Study publicly available on registry
January 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedDecember 2, 2016
October 1, 2016
1.8 years
January 21, 2009
December 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo
4 weeks
Secondary Outcomes (8)
RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given)
4 weeks
Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment
4 weeks
Level of exhaled nitric oxide after 4 weeks of treatment
4 weeks
mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper)
4 weeks
Mean change of ACQ after 4 weeks of treatment
4 weeks
- +3 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORCiclesonide 320µg
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
- years old
You may not qualify if:
- Smoker and ex-smoker with \>10 pack years
- COPD
- Upper respiratory tract infection within the past 4 weeks.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Nycomed
Basel, 4031, Switzerland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca AstraZeneca
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2009
First Posted
January 22, 2009
Study Start
September 1, 2008
Primary Completion
July 1, 2010
Study Completion
October 1, 2011
Last Updated
December 2, 2016
Record last verified: 2016-10