Ciclesonide for the Treatment of Airway Hyperresponsiveness

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Ciclesonide

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Nycomed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Placebo; Placebo
Active Comparator: 1; Ciclesonide 320µg	Drug: Ciclesonide; 320µg Ciclesonide versus Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Mean change of AQLQ 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
Exacerbation rates during the 4 weeks of treatment	4 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

Helpful Links

• BY9010-CH-101-RDS-2012-10-29.pdf

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: January 21, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Estimate): December 2, 2016
• Last Update Submitted That Met QC Criteria: December 1, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Asthma; Ciclesonide
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Hypersensitivity; Asthma; Respiratory Hypersensitivity; Physiological Effects of Drugs; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Allergic Agents; Ciclesonide
• Other Study ID Numbers: BY9010/CH-101; U1111-1137-3949 (Registry Identifier: WHO)