Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)
NCT00163332 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2016-12-06
Summary
The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Conditions
Interventions
- DRUG
-
Ciclesonide
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
AstraZeneca AstraZeneca · AstraZeneca
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-31
Countries
- Belgium
Study Locations
More Related Trials
-
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
NCT00163410 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)
NCT00163345 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)
NCT00163397 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)
NCT00163371 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)
NCT00163293 ·Status: COMPLETED ·Phase: PHASE3
-
Effectiveness of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-136)
NCT00163384 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid
NCT00174733 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)
NCT00163436 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Ciclesonide During the Cold Season in Patients Older Than 12 Years With Persistent Asthma
NCT00608218 ·Status: COMPLETED
-
Effect of High Dose Ciclesonide on Asthma Control
NCT01455194 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients
NCT01577082 ·Status: COMPLETED ·Phase: PHASE3
-
Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?
NCT00716963 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison Between CHF5993 pMDI 200/6/12.5 µg HFA-152a VS CHF5993 pMDI 200/6/12.5 µg HFA-134a in Subjects With Asthma (TRECOS).
NCT06264674 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Inhaled Ciclesonide in Adult Patients With Asthma (BY9010/M1-125)
NCT00546520 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)
NCT00305461 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Ciclesonide vs Placebo Administered as Once Daily or Twice Daily in Patients Not Treated With Inhaled Corticosteroid.
NCT00174720 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Tolerability of Ciclesonide and Formoterol Fumarate Inhaled Once Daily in Patients With Asthma (18 to 75 y) (BY9010/M1-506)
NCT00314509 ·Status: COMPLETED ·Phase: PHASE2
-
Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA
NCT05018598 ·Status: TERMINATED ·Phase: PHASE4
-
Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroid (ICS)
NCT01397201 ·Status: TERMINATED ·Phase: PHASE2
-
BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
NCT01103349 ·Status: COMPLETED ·Phase: PHASE2
-
Does Inhaled Busedonide or Fluticasone Impair Adrenal Function?
NCT00560625 ·Status: TERMINATED
-
Therapeutic Equivalence of CHF5993 pMDI 100/6/12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma
NCT07301736 ·Status: RECRUITING ·Phase: PHASE2
-
Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma
NCT02139644 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
NCT00392288 ·Status: COMPLETED ·Phase: PHASE3
-
A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid
NCT05292586 ·Status: COMPLETED ·Phase: PHASE3