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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)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: April 11, 2006
Last updated: December 2, 2016
Last verified: December 2016
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
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 AstraZeneca:

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
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  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 identifier: NCT00314509

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
Study Director: AstraZeneca AstraZeneca AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00314509     History of Changes
Other Study ID Numbers: BY9010/M1-506
Study First Received: April 11, 2006
Last Updated: December 2, 2016

Keywords provided by AstraZeneca:
Formoterol Fumarate
Long-acting beta2-agonists

Additional relevant MeSH terms:
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 processed this record on September 18, 2017