Asthma bronchial MedDRA version: 8.1 Level: LLT Classification code 10003555 Term: Asthma bronchial
Conditions
Interventions
Trade Name: Alvesco 160
Product Name: Ciclesonide MDI
Pharmaceutical Form: Pressurised inhalation, solution
INN or Proposed INN: Ciclesonide
CAS Number: 126544-47-6
Concentration unit: µg microgram(s)
Sponsors
Nycomed GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female outpatients aged 6 to 11 years, - History of persistent bronchial asthma (as defined by GINA 2004 criteria) for at least 6 months, - Ability to perform reproducible pulmonary function tests, - Ability to show optimal use of MDI, including inhalation technique, - Either treatment with rescue medication prn only or treatment with ICS (not exceeding 200 µg/d fluticasone propionate [FP] or equivalent), or treatment with a non-ICS controller drug (e.g., cromones, xanthines, leukotriene antagonists, lipoxygenase inhibitors. or inhaled long-acting ß2-agonists [LABA]), respectively, at a constant dose over the last 30 days directly prior to B0, - PEF (% of predicted value) measured by spirometry at least 4 hours after inhalation of rescue medication (e.g. a short-acting ß2-agonist [SABA]), and at least 24 hours after the use of LABA, xanthines, or oral bronchodilators: - 40% - 90% for patients using rescue medication only, - 50% - 100% for patients using ICS, - 50% - 100% for patients using non-ICS controller drugs. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of any one of the following will cause exclusion of the patient: a) Diseases and health status: - Concomitant severe diseases, - Diseases which are contraindications for the use of ICS (e. g. active or inactive pulmonary tuberculosis, or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment), - Chronic obstructive pulmonary disease (COPD; i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function, - Respiratory tract infection or asthma exacerbation within the last 30 days prior to B0 as well as during baseline, - Two or more inpatient hospitalizations for asthma within the last year (with the exception of hospitalizations for diagnostic reasons), - Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation, - History of life-threatening asthma (i.e. prior intubation for asthma and/or respiratory arrest, anoxic seizures, significant hypercarbia in the setting of an asthma exacerbation), - Premature birth (i.e. or = 10 years of age or post-menarchal): Female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. - Participation in another study within the 30 days preceding and during the present study, - Previous enrollment into the current study, - Known or suspected non-compliance, alcohol or drug abuse, - Inability to follow the procedures of the study, due to e.g. language problems, psychological disorders, - Patient’s parent(s)/legal guardian(s) is(are), in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, - Patient or parent(s)/legal guardian(s) intend(s) to relocate during the course of the study, preventing adherence to visit schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare the efficacy of ciclesonide (CIC; 40 µg, 80 µg and 160 µg ex mouthpiece) vs. placebo, both administered either with or without a spacer once daily (OD) in the evening (PM), in children with persistent asthma.;Secondary Objective: - To further study the dose response of CIC 40 µg, 80 µg and 160 µg ex mouthpiece, administered either with or without a spacer in children. - To investigate the safety and tolerability of CIC 40 µg, 80 µg and 160 µg ex mouth-piece, administered either with or without a spacer in children.;Primary end point(s): Morning peak expiratory flow from diary (last week compared to week 0 [W0]) | — |
Countries
Germany, Hungary, Spain
Outcome results
None listed