The Mannitol-Asthma-Ciclesonide-Study

Asthma, Bronchial Clinical Trial

— MACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839433
• Other study ID #: BY 9010 / CH-101
• Status: Completed
• Phase: Phase 4
• Start date: June 2007
• Est. completion date: August 2008

Study information

• Verified date: July 2019
• Source: Cantonal Hosptal, Baselland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma, Bronchial

Intervention

Drug:
• Ciclesonide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hosptal, Baselland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of hyperresponsiveness to mannitol by measuring PD15 FEV1 after 4 weeks (improvement of more than at least 1.5 doubling dose)	measurements of PD15 FEV1 (provocative dose to produce a 15% fall in FEV1), bronchial hyperresponsiveness. A 15 % reduction of FEV1 means a bronchial hyperresponsiveness	4 weeks
Secondary	Change in PD20 FEV1 methacholine (Responsiveness to metacholine)	measurements of PD20 FEV1 (provocative dose to produce a 20% fall in FEV1) bronchial hyperresponsiveness. A 20 % reduction of FEV1 means a bronchial hyperresponsiveness	4 weeks
Secondary	Change in FeNO (Nitric Oxide)	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.	4 weeks
Secondary	Change in ACQ (Asthma Control Questionnaire)	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).	4 weeks
Secondary	AQLQ (Asthma Quality of Life Questionnaire)	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.	4 weeks