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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314509
Recruitment Status : Completed
First Posted : April 14, 2006
Last Update Posted : December 5, 2016
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide/Formoterol Combination Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : July 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314509

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Altana Pharma/Nycomed
Grenoble, France, 38100
Altana Pharma/Nycomed
Montpellier, France, 34295
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
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
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Study Director: AstraZeneca AstraZeneca AstraZeneca

Additional Information:
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Responsible Party: AstraZeneca Identifier: NCT00314509    
Other Study ID Numbers: BY9010/M1-506
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: December 5, 2016
Last Verified: December 2016
Keywords provided by AstraZeneca:
Formoterol Fumarate
Long-acting beta2-agonists
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Allergic Agents