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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)

NCT00163332

Asthma

COMPLETED PHASE3

Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)

NCT00163319

Asthma

COMPLETED PHASE3

Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)

NCT00163358

Asthma

COMPLETED PHASE3

Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)

NCT00163423

Asthma

COMPLETED PHASE3

Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)

NCT00163345

Asthma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Ciclesonide 160 µg

Group Type ACTIVE_COMPARATOR

Ciclesonide

Intervention Type DRUG

inhaled Ciclesonide 160 µg, once daily in the morning

2

Fluticasone 100 µg

Group Type ACTIVE_COMPARATOR

Fluticasone

Intervention Type DRUG

inhaled Fluticasone 100 µg, twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ciclesonide

inhaled Ciclesonide 160 µg, once daily in the morning

Intervention Type DRUG

Fluticasone

inhaled Fluticasone 100 µg, twice daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No