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Completed

NCT Number: NCT00163345

Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)

The aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, CT-scanning, and cellular markers of inflammation. Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide further data on safety and tolerability 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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed

RB Groningen, 9700, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Written informed consent
  • History of bronchial asthma
  • FEV1 more than or equal to 60% of predicted
  • Stable asthma
  • Patients who are in good health with the exception of asthma

Main Exclusion Criteria:

  • Concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ICS
  • COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
  • Use of ICS 4 weeks before entry into the baseline period
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception
  • Use of other drugs not allowed
  • Current smokers and ex-smokers with more than or equal to 10 pack-years

Treatment and study plan

Ciclesonide

Drug

Primary outcomes

  1. variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh

  2. FVC% at PC20 AMP, SVC% at PC20 AMP

  3. regional air trapping

  4. bronchial and alveolar exhaled NO

  5. lung function variables

  6. non-cellular inflammatory markers.

Secondary outcomes

  1. safety and tolerability.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 mcg Once Daily) Versus Placebo in Patients With Asthma

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Dec 8, 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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