The Mannitol-Asthma-Ciclesonide-Study

NCT03839433 | Completed Phase 4

• 1 other identifier: BY 9010 / CH-101
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Asthma, Bronchial

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in PD20 FEV1 methacholine (Responsiveness to metacholine)

  4 weeks

• Change in FeNO (Nitric Oxide)

  4 weeks

• Change in ACQ (Asthma Control Questionnaire)

  4 weeks

• AQLQ (Asthma Quality of Life Questionnaire)

  4 weeks

Study Arms (2)

ciclesonide positive

ACTIVE COMPARATOR

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.

Drug: Ciclesonide

Placebo

PLACEBO COMPARATOR

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.

Drug: Ciclesonide

Interventions

Ciclesonide DRUG

Placebo; ciclesonide positive

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Smoker and ex-smoker with \>10 pack years
• COPD (chronic obstructive pulmonary disease)
• Upper respiratory tract infection within the past 4 weeks.
• 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

Sponsors & Collaborators

• Cantonal Hosptal, Baselland: lead

MeSH Terms

Conditions

Asthma

Interventions

ciclesonide

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: February 15, 2019
• Study Start: June 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: July 25, 2019

Record last verified: 2019-07