The Mannitol-Asthma-Ciclesonide-Study

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway hyperresponsiveness assessed with mannitol.

Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of hyper-responsive patients compared to 20% only in the placebo group and the group without airway hyper-responsiveness.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cantonal Hosptal, Baselland
• Treatments: Ciclesonide; Mannitol

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 (Global Initiative for Asthma, October 2006) 1 week prior to randomization

• FEV1 ≥ 70% predicted

Exclusion Criteria:

• Smoker and ex-smoker with >10 pack years

• COPD (chronic obstructive pulmonary disease)

• Upper respiratory tract infection within the past 4 weeks.

• ICS or oral steroids during the previous month before inclusion

• beta-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