The Mannitol-Asthma-Ciclesonide-Study (MACS)

Cantonal Hosptal, Baselland

Status and phase: Completed; Phase 4

Conditions: Asthma, Bronchial

Treatments: Drug: Ciclesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT03839433

BY 9010 / CH-101

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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 (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

ciclesonide positive

Active Comparator group

Description:

Half of the Mannitol positive patients were given ciclesonide. Half of the Mannitol negative patients were given ciclesonide. All patients in the "ciclesonide positive" arm received ciclesonide.

Treatment:

Drug: Ciclesonide

Placebo

Placebo Comparator group

Description:

Half of the Mannitol positive patients were given a placebo. Half of the Mannitol negative patients were given a placebo. All patients in the "placebo" arm received placebo.

Treatment:

Drug: Ciclesonide