The Mannitol-Asthma-Ciclesonide-Study

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.

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Key information

Conditions

Asthma, Bronchial Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ciclesonide

Drug

Primary outcomes

Change of hyperresponsiveness to mannitol by measuring PD15 FEV1 after 4 weeks (improvement of more than at least 1.5 doubling dose)

Time frame: 4 weeks

measurements of PD15 FEV1 (provocative dose to produce a 15% fall in FEV1), bronchial hyperresponsiveness. A 15 % reduction of FEV1 means a bronchial hyperresponsiveness

Secondary outcomes

Change in PD20 FEV1 methacholine (Responsiveness to metacholine)

Time frame: 4 weeks

measurements of PD20 FEV1 (provocative dose to produce a 20% fall in FEV1) bronchial hyperresponsiveness. A 20 % reduction of FEV1 means a bronchial hyperresponsiveness
Change in FeNO (Nitric Oxide)

Time frame: 4 weeks

Measurement of bronchial inflammation. It determines the level of nitric oxide in parts per billion (PPB). Nitric oxide in exhaled air is another marker of airway inflammation. Subjects with atopic asthma or rhinitis seem to have elevated expiratory nitric oxide (eNO) levels.
Change in ACQ (Asthma Control Questionnaire)

Time frame: 4 weeks

It measures both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. It measures both the adequacy of asthma control and change in asthma control, which occurs either spontaneously or as a result of treatment. The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
AQLQ (Asthma Quality of Life Questionnaire)

Time frame: 4 weeks

The Asthma Quality of Life Questionnaire (AQLQ) was developed to measure the functional problems (physical, emotional, social and occupational) that are most troublesome to adults (17-70 years) with asthma. There are 32 questions in the AQLQ and they are in 4 domains (symptoms, activity limitation, emotional function and environmental stimuli). The activity domain contains 5 'patient-specific' questions. This allows patients to select 5 activities in which they are most limited and these activities will be assessed at each follow-up. Patients are asked to think about how they have been during the previous two weeks and to respond to each of the 32 questions on a 7-point scale (7 = not impaired at all - 1 = severely impaired). The overall AQLQ score is the mean of all 32 responses and the individual domain scores are the means of the items in those domains.

Sponsors and collaborators

Lead sponsor

Cantonal Hosptal, Baselland

Other

Registry information

Official study title

Ciclesonide for the Treatment of Airway Hyperresponsiveness: The Mannitol-Asthma-Ciclesonide-Study

Acronym: MACS

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Feb 15, 2019
Registry last updated: Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed