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Ciclesonide for the Treatment of Airway Hyperresponsiveness

Primary Purpose

Asthma

Status

Completed

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

Ciclesonide

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Ciclesonide

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (October 2006) 1 week prior to randomization
FEV1 ≥ 70% predicted
18 - 70 years old

Exclusion Criteria:

Smoker and ex-smoker with >10 pack years
COPD
Upper respiratory tract infection within the past 4 weeks.
ICS or oral steroids during the previous month before inclusion
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

Sites / Locations

Nycomed

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Ciclesonide 320µg

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00826969

First Posted

January 21, 2009

Last Updated

December 1, 2016

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00826969

Brief Title

Ciclesonide for the Treatment of Airway Hyperresponsiveness

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Asthma, Ciclesonide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Ciclesonide 320µg

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

Ciclesonide

Intervention Description

320µg Ciclesonide versus Placebo

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given)

Time Frame

4 weeks

Title

Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment

Time Frame

4 weeks

Title

Level of exhaled nitric oxide after 4 weeks of treatment

Time Frame

4 weeks

Title

mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper)

Time Frame

4 weeks

Title

Mean change of ACQ after 4 weeks of treatment

Time Frame

4 weeks

Title

Mean change of AQLQ after 4 weeks of treatment

Time Frame

4 weeks

Title

Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment

Time Frame

4 weeks

Title

Exacerbation rates during the 4 weeks of treatment

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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 (October 2006) 1 week prior to randomization FEV1 ≥ 70% predicted 18 - 70 years old Exclusion Criteria: Smoker and ex-smoker with >10 pack years COPD Upper respiratory tract infection within the past 4 weeks. ICS or oral steroids during the previous month before inclusion 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AstraZeneca AstraZeneca

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Nycomed

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4509&filename=BY9010-CH-101-RDS-2012-10-29.pdf

Description

BY9010-CH-101-RDS-2012-10-29.pdf

Learn more about this trial

Ciclesonide for the Treatment of Airway Hyperresponsiveness

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