Ciclesonide for the Treatment of Airway Hyperresponsiveness

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 2010

Interventions

  • Drug: Ciclesonide
    • 320µg Ciclesonide versus Placebo
  • Drug: Placebo
    • Placebo

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Ciclesonide 320µg
  • Placebo Comparator: 2
    • Placebo

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • RDR mannitol (response-dose-ratio = ll in FEV1 / provocation dose given)
    • Time Frame: 4 weeks
  • Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment
    • Time Frame: 4 weeks
  • Level of exhaled nitric oxide after 4 weeks of treatment
    • Time Frame: 4 weeks
  • mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper)
    • Time Frame: 4 weeks
  • Mean change of ACQ after 4 weeks of treatment
    • Time Frame: 4 weeks
  • Mean change of AQLQ after 4 weeks of treatment
    • Time Frame: 4 weeks
  • Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment
    • Time Frame: 4 weeks
  • Exacerbation rates during the 4 weeks of treatment
    • Time Frame: 4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • AstraZeneca AstraZeneca, Study Director, AstraZeneca

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