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Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)

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: NCT00306163
Recruitment Status : Completed
First Posted : March 23, 2006
Results First Posted : April 26, 2010
Last Update Posted : February 1, 2017
Information provided by (Responsible Party):

Brief Summary:
The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Condition or disease Intervention/treatment Phase
Asthma Drug: Ciclesonide Drug: Fluticasone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone.
Study Start Date : May 2006
Primary Completion Date : August 2008
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Ciclesonide 160 µg
Drug: Ciclesonide
inhaled Ciclesonide 160 µg, once daily in the morning
Active Comparator: 2
Fluticasone 100 µg
Drug: Fluticasone
inhaled Fluticasone 100 µg, twice daily

Primary Outcome Measures :
  1. PC20 AMP (Post-treatment Compared to Baseline) [ Time Frame: Baseline and 5 weeks ]
    Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron

Secondary Outcome Measures :
  1. Δ (FVC/SVC) at PC20 (AMP) [ Time Frame: Baseline and 5 weeks ]
    Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP.

  2. Safety and Tolerability [ Time Frame: 5 weeks ]

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Main Inclusion Criteria:

  • History of bronchial asthma
  • FEV1 > 1.20 L
  • Positive Skin Prick Test
  • Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit

Main Exclusion Criteria:

  • Clinically relevant abnormal laboratory values
  • Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
  • Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases
  • One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
  • Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
  • Positive response to saline challenge at baseline visits
  • Positive bronchial hyperresponsiveness

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): NCT00306163

Altana Pharma/Nycomed
RB Groningen, Netherlands, 9700
Sponsors and Collaborators
Study Director: AstraZeneca AstraZeneca AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00306163     History of Changes
Other Study ID Numbers: BY9010/NL-101
First Posted: March 23, 2006    Key Record Dates
Results First Posted: April 26, 2010
Last Update Posted: February 1, 2017
Last Verified: September 2016

Keywords provided by AstraZeneca:
Fluticasone propionate

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists