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Completed

NCT Number: NCT00163358

Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)

The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). 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

12 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Adelaide South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

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

Main Inclusion Criteria:

  • Clinical diagnosis of mild persistent asthma
  • Pre-treatment with SABAs only
  • FEV1 ≥80% predicted
  • Good health with the exception of asthma

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
  • COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
  • Pregnancy
  • Intention to become pregnant during the course of the study
  • Breast feeding
  • Lack of safe contraception
  • Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years

Treatment and study plan

Ciclesonide

Drug

Primary outcomes

  1. time until the first severe asthma exacerbation occurs

  2. number of poorly controlled asthma days.

Secondary outcomes

  1. percentage of days with asthma control

  2. percentage of days with asthma symptoms

  3. percentage of nocturnal awakenings due to asthma

  4. asthma symptom score

  5. number of inhalations of rescue medication

  6. proportion of patients with severe asthma exacerbations

  7. differences in morning PEF from diary

  8. differences in FEV1 and FVC from spirometry

  9. blood eosinophils

  10. AQLQ(S)

  11. health economic data

  12. vital signs

  13. laboratory work-up

  14. adverse events.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 14, 2005
Registry last updated
Nov 30, 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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