Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12 Week Randomized, Double-blind, Double-Dummy, Placebo-controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Children (at Least 6years of Age) and Adults With Asthma-SPRUCE 80/4.5
Brief Summary: The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults


Options:
A: Inclusion Criteria:

1. Individuals who self-report Black ancestry (with at least 1 Black grandparent).
2. Able to perform reproducible spirometry according to ATS criteria.
3. Clinical history consistent with asthma.
4. Baseline FEV1≥40% of predicted and/or post-bronchodilator FEV1≥40% of predicted.
5. Asthma confirmed either by: (1) Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR (2) PC20FEV1 ≤ 16 mg/ml OR (3) an absolute relative change in %predicted FEV1 of ≥ 12% over two measurements documented by repeat spirogram over the previous year
6. Either: A) inadequately controlled on low-, medium- or high-dose ICS monotherapy, or low- or medium-dose ICS/LABA, or B) well-controlled on medium- or high-dose ICS monotherapy, or low-, medium- or high-dose ICS/LABA. Inadequate asthma control will be defined as an ACT/c-ACT score \<20; well-controlled asthma will be defined as an ACT/c-ACT score ≥20.
7. Stable asthma controller therapy dose (ICS or ICS/LABA) for the 2 weeks prior to enrollment.
8. Non-smoker (total lifetime smoking history \< 5 pack-years if \<18, or \<10 pack-years if ≥18 years of age; no smoking for at least 1 year).
9. For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.

Exclusion Criteria:

1. Medical contraindication to LABA or history of adverse reactions to ICS or LABA preparations or any of their ingredients.
2. Current or prior use of medications known to significantly interact with corticosteroid disposition within the two-week period preceding enrollment.
3. Unwilling to provide a blood sample for DNA extraction and genetic analysis.
4. Major medical problems prohibiting study participation, i.e. presence of chronic or active lung disease other than asthma or history of unstable significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study or that would place the participant at increased risk.
5. Systemic corticosteroid treatment for any condition within 4 weeks of enrollment or more than five courses of systemic corticosteroids in the past year.
6. History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years.
7. History of a respiratory tract infection within 4 weeks of enrollment.
8. If a female of child-bearing potential, failure to practice abstinence or use an acceptable birth control method.
9. Pregnancy or lactation or planning to get pregnant during the course of the trial.
10. Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment.
11. Participation in an intervention trial or use of investigative drugs in the past 30 days or plans to enroll in such a trial during the study.
B: Inclusion Criteria:

* Outpatient at least 12 years of age
* Both genders; females of childbearing potential must be willing to use birth control method
* Pre-bronchodilator FEV1 of 40-90% predicted
* Reversibility FEV1 of at least 12% and 200mls
* Current asthma therapy that includes an inhaled corticosteroid for at least 12 weeks prior to first visit

Exclusion Criteria:

* History of life-threatening asthma
* Respiratory infection or oral candidiasis
* Asthma exacerbation within 12 weeks
* Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drugs' excipients, medications related to study drugs
* Taking another investigational medication or medication prohibited for use during this study
C: Inclusion Criteria:

* Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
* Male or Female, ≥12 years of age
* Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
* Patient must have history of at least 1 asthma exacerbation including one of the following:

  * requiring treatment with systemic corticosteroids
  * an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
* Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire

Exclusion Criteria:

* Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
* Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
* Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
* An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
* Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
* Patient must not meet unstable asthma severity criteria as listed in the protocol
* Peak expiratory flow must not be below 50% o predicted normal
* Pregnancy, breast-feeding or planned pregnancy during the study
D: Inclusion Criteria:

* At least 6 years of age
* Diagnosis of asthma
* Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Severe asthma
* Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Answer: D