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Completed

NCT Number: NCT00826969

Ciclesonide for the Treatment of Airway Hyperresponsiveness

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.

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Key information

Conditions

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

Primary location

Nycomed

Basel, 4031, Switzerland

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 (October 2006) 1 week prior to randomization
  • FEV1 ≥ 70% predicted
  • 18 - 70 years old

Exclusion criteria

  • Smoker and ex-smoker with >10 pack years
  • COPD
  • Upper respiratory tract infection within the past 4 weeks.
  • ICS or oral steroids during the previous month before inclusion
  • b-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

320µg Ciclesonide versus Placebo

Placebo

Drug

Placebo

Primary outcomes

  1. Change of hyper-responsiveness to mannitol assessed by PD15FEV1 after 4 weeks of treatment with ciclesonide vs Placebo

    Time frame: 4 weeks

Secondary outcomes

  1. RDR mannitol (response-dose-ratio = %fall in FEV1 / provocation dose given)

    Time frame: 4 weeks

  2. Responsiveness to methacholine (PD20FEV1 ) and RDR methacholine after 4 weeks of treatment

    Time frame: 4 weeks

  3. Level of exhaled nitric oxide after 4 weeks of treatment

    Time frame: 4 weeks

  4. mean improvement of FEV1 and PEF, mean change of the asthma control questionnaire ACQ (Juniper)

    Time frame: 4 weeks

  5. Mean change of ACQ after 4 weeks of treatment

    Time frame: 4 weeks

  6. Mean change of AQLQ after 4 weeks of treatment

    Time frame: 4 weeks

  7. Mean change of symptoms, rescue medication use, nocturnal awakening according to GINA after 4 weeks of treatment

    Time frame: 4 weeks

  8. Exacerbation rates during the 4 weeks of treatment

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jan 22, 2009
Registry last updated
Dec 2, 2016

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.

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