Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Ciclesonide and of a Fixed Combination With Fluticasone Propionate and Salmeterol Versus Placebo on Long-term Asthma Control
Brief Summary: The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.


Options:
A: Inclusion Criteria:

* Females between 5 and 7.5 years and male between 5 and 8.5 years of age with normal heights, a history of mild persistent asthma for at least 3 months prior to visit 1, a forced expiratory volume in one second (FEV1) of ³80% of predicted following at least a 4-hour albuterol withhold, and treated with non-corticosteroid asthma medications on an as-needed or daily basis, or with low doses of inhaled corticosteroids (ICSs) for at least one month prior to Visit 1. Subjects were to be no greater than Stage 1 in the Tanner classification of sexual maturity, and they had to be able to demonstrate effective use of the MDI devices and perform reproducible pulmonary function test.

Exclusion Criteria:

* Subjects with a history of life-threatening asthma, severe respiratory impairment, history of abnormal growth, concurrent disease or condition which may substantially affect growth, previous requirement for daily or alternate day oral corticosteroids (OCS) treatment for ³60 days within the 2 years of Visit 3 and/or any use of OCS within 30 days prior to Visit 1 or during the run-in period, previous treatment with moderate or high doses of inhaled corticosteroid during the 30 days prior to Visit 1
B: Inclusion Criteria:

* Males or females 12 years or older
* History of persistent bronchial asthma for at least 6 months
* Documented use of an inhaled steroid or a combination of an inhaled steroid/long-acting beta 2 agonist for at least 1 month before screening
* At screening, FEV1 of 60 to 90% predicted or 70 to 95% predicted for either ICS or ICS/LABA use respectively.Reversibility of FEV1 by at least 12% and 200 ml post-bronchodilator
* Be able to use oral inhalers
* Non-smokers

Exclusion Criteria:

* History of life-threatening asthma
* Other pulmonary diseases; URI within 4 weeks before screening
* Use of systemic steroids within 1 month before screening or more than 3 times in previous 6 months
* Beta-adrenergic blocking agent use
* More than 2 in-patient hospitalizations or ER visits due to asthma exacerbations in the prior year before screening
* Pregnant or breast-feeding females
* Females of child-bearing potential not using adequate means of birth control
* Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease
* Abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results
* History of drug or alcohol abuse
* Treatment with any investigational product within 30 days prior to study entry
C: Main Inclusion Criteria:

* Clinical diagnosis of mild persistent asthma
* Pre-treatment with SABAs only
* FEV1 ≥80% predicted
* Good health with the exception of asthma

Main Exclusion Criteria:

* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
* Pregnancy
* Intention to become pregnant during the course of the study
* Breast feeding
* Lack of safe contraception
* Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
D: Main Inclusion Criteria:

* History of asthma for at least 6 months
* Ability to show optimal use of MDI, including inhalation technique
* Lung function and reversibility within specified limits

Main Exclusion Criteria:

* Concomitant severe diseases
* Diseases which are contraindications for the use of inhaled steroids
* Two or more inpatient hospitalizations for asthma within the last year
* Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
* Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6 weeks)
* Beginning of or change in immunotherapy within the last 6 months prior to inclusion
* Inability to follow the procedures of the study

Answer: C