Ciclesonide for the Treatment of Airway Hyperresponsiveness

Asthma Clinical Trial

Official title:

Ciclesonide for the Treatment of Airway Hyperresponsiveness. The Mannitol-Asthma-Ciclesonide Study (MACS). A Double-blind, Randomized, Parallel Group Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826969
• Other study ID #: BY9010/CH-101
• Secondary ID: U1111-1137-3949
• Status: Completed
• Phase: Phase 4
• First received: January 21, 2009
• Last updated: December 1, 2016
• Start date: September 2008
• Est. completion date: October 2011

Study information

• Verified date: October 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Respiratory Hypersensitivity

Intervention

Drug:
• Ciclesonide
320µg Ciclesonide versus Placebo
• Placebo
Placebo

Locations

Country	Name	City	State
Switzerland	Nycomed	Basel

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo		4 weeks	No
Secondary	RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given)		4 weeks	No
Secondary	Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment		4 weeks	No
Secondary	Level of exhaled nitric oxide after 4 weeks of treatment		4 weeks	No
Secondary	mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper)		4 weeks	No
Secondary	Mean change of ACQ after 4 weeks of treatment		4 weeks	No
Secondary	Mean change of AQLQ after 4 weeks of treatment		4 weeks	No
Secondary	Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment		4 weeks	Yes
Secondary	Exacerbation rates during the 4 weeks of treatment		4 weeks	Yes

External Links

•   BY9010-CH-101-RDS-2012-10-29.pdf