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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00314509
First received: April 11, 2006
Last updated: May 4, 2012
Last verified: July 2008
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Ciclesonide/Formoterol Combination
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

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

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

Estimated Enrollment: 240
Study Start Date: July 2005
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314509

Locations
France
Altana Pharma/Nycomed
Grenoble, France, 38100
Altana Pharma/Nycomed
Montpellier, France, 34295
Germany
Altana Pharma/Nycomed
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
Hungary
Altana Pharma/Nycomed
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
South Africa
Altana Pharma/Nycomed
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
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: Eric D. Bateman, Prof. UCT Lung Institute, 7700 Mowbray, Cape Town, South Africa
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00314509     History of Changes
Other Study ID Numbers: BY9010/M1-506
Study First Received: April 11, 2006
Last Updated: May 4, 2012
Health Authority: South Africa: Medicines Control Council

Keywords provided by Takeda:
Asthma
Ciclesonide
Formoterol Fumarate
Long-acting beta2-agonists
LABA
Steroids

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Ciclesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 18, 2014