Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)

December 2, 2016 updated by: AstraZeneca

ADVICE: A Dose Range Finding Study of Formoterol Administered Once Daily in the Evening in Combination With Ciclesonide Using the Ultrahaler™ Versus Monotherapy of Each Drug in Asthmatic Patients

The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

240

Phase

  • Phase 2

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

  • France
      • Grenoble, France, 38100
        • Altana Pharma/Nycomed
      • Montpellier, France, 34295
        • Altana Pharma/Nycomed
  • Germany
      • Berlin, Germany, 14050
        • Altana Pharma/Nycomed
      • Großhansdorf, Germany, 22927
        • Altana Pharma/Nycomed
      • Mainz, Germany, 55131
        • Altana Pharma/Nycomed
      • Rüdersdorf, Germany, 15562
        • Altana Pharma/Nycomed
      • Wiesbaden, Germany, 65187
        • Altana Pharma/Nycomed
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Altana Pharma/Nycomed
      • Balatonfüred, Hungary, 8230
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1125
        • Altana Pharma/Nycomed
      • Budapest, Hungary, 1529
        • Altana Pharma/Nycomed
      • Csorna, Hungary, 9300
        • Altana Pharma/Nycomed
      • Debrecen, Hungary, 4043
        • Altana Pharma/Nycomed
      • Györ, Hungary, 9024
        • Altana Pharma/Nycomed
      • Matrahaza, Hungary, 3233
        • Altana Pharma/Nycomed
      • Mosonmagyaróvár, Hungary, 9200
        • Altana Pharma/Nycomed
      • Nyíregyháza, Hungary, 4400
        • Altana Pharma/Nycomed
      • Szolnok, Hungary, 5006
        • Altana Pharma/Nycomed
      • Szombathely, Hungary, 9700
        • Altana Pharma/Nycomed
  • South Africa
      • Arcadia, Pretoria, South Africa, 132
        • Altana Pharma/Nycomed
      • Bellville, Cape Town, South Africa, 7530
        • Altana Pharma/Nycomed
      • Bloemfontein, South Africa, 9300
        • Altana Pharma/Nycomed
      • Cape Town, Tygerberg, South Africa, 7505
        • Altana Pharma/Nycomed
      • Mowbray, Cape Town, South Africa, 7925
        • Altana Pharma/Nycomed
      • Panorama / RSA-Cape Town, South Africa, 7500
        • Altana Pharma/Nycomed
      • Pretoria, South Africa
        • 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • Written informed consent
  • Good health with the exception of bronchial asthma (for at least 6 months)
  • FEV1 > 60% to < 80% of predicted (if pretreated with inhaled steroids only)
  • FEV1 > 60% to ≤ 85% of predicted (if pretreated with inhaled steroids in combination with other asthma controller)

Main Exclusion Criteria:

  • Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or long-acting beta2-agonists
  • Chronic obstructive pulmonary disease (COPD), i.e. chronic bronchitis or emphysema, and/or other relevant lung diseases causing alternating impairment in pulmonary function
  • Current smoking or cessation of smoking within the last 6 months or previous smoking with a smoking history ≥ 10 cigarette pack-years
  • Use of other drugs not allowed
  • Pregnancy or intention to become pregnant during the course of the study, breast feeding, or lack of safe contraception in women of childbearing potential

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to the first experience of lack of efficacy
AUC (FEV1) over a 24 h dosing interval.

Secondary Outcome Measures

Outcome Measure
FEV1
morning and evening PEF, asthma symptoms and use of rescue medication
proportion of patients with a clinical asthma exacerbation.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

July 1, 2005

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 12, 2006

First Posted (Estimate)

April 14, 2006

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY9010/M1-506

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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