Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)

December 5, 2016 updated by: AstraZeneca

A 3-period Double-blind, Cross-over Study on the Onset of Action of Inhaled Ciclesonide (7 Days of 400 mcg Sid Versus 800 mcg Bid Versus Placebo) on Airway Responsiveness to Adenosine Monophosphate (AMP), Sputum Eosinophiles and Exhaled Breath Nitric Oxide (NO) in Patients With Asthma

Ciclesonide is a novel inhaled corticosteroid for the treatment of asthma. In this study the effect of ciclesonide on airway hyperresponsiveness (AHR), exhaled nitric oxide (NO), and induced sputum inflammatory biomarkers will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • "Altana Pharma/Nycomed"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main inclusion criteria:

  • Out-patients
  • Written informed consent
  • History of atopic disease
  • History of perennial bronchial asthma for at least 6 months as defined by ATS criteria
  • Current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period B0)
  • Stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start
  • FEV1 ≥ 70% predicted
  • Hyperreactivity to AMP (PC20FEV1 < 25 mg/ml)
  • Good health with the exception of asthma
  • Non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence

Main exclusion criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis)
  • Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
  • Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
  • Pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year
  • COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases
  • Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers
  • Immunotherapy within one month prior to B0 and/or during the entire study duration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
PC20FEV1 (AMP)

Secondary Outcome Measures

Outcome Measure
Baseline FEV1 from spirometry, exhaled NO, eosinophils, basophils, and mast cells determined from induced sputum; Safety variables: Physical examination, vital signs, ECG, laboratory work-up, and adverse events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

June 1, 2002

Study Completion (Actual)

June 1, 2002

Study Registration Dates

First Submitted

October 18, 2007

First Submitted That Met QC Criteria

October 18, 2007

First Posted (Estimate)

October 19, 2007

Study Record Updates

Last Update Posted (Estimate)

December 7, 2016

Last Update Submitted That Met QC Criteria

December 5, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY9010/M1-125

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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