Ciclesonide for the Treatment of Airway Hyperresponsiveness

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Ciclesonide; Drug: Placebo

• Registration Number: NCT00826969
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2010-07
• Study Completion: 2011-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ciclesonide	Ciclesonide 320µg
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo	4 weeks

Secondary Outcome Measures

Name	Time	Method
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
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
Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment	4 weeks
Level of exhaled nitric oxide after 4 weeks of treatment	4 weeks
Mean change of AQLQ after 4 weeks of treatment	4 weeks
Exacerbation rates during the 4 weeks of treatment	4 weeks

Trial Locations

Locations (1)

Nycomed; 🇨🇭 Basel, Switzerland