Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Symbicort Single Inhaler Therapy on Bronchial Hyper Responsiveness, Asthma Control and Safety in Mild to Moderate Asthmatics in General Practice, Compared to Usual Care Therapy
Brief Summary: The primary objective is to compare the effects of Symbicort SiT and treatment according to NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20 histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).


Options:
A: Inclusion Criteria:

* Provision of signed informed consent
* Asthma diagnosis at least 6 months before visit 1 of study
* Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study

Exclusion Criteria:

* Known or suspected allergy to active ingredients of study medication or excipients
* Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study
* Smoking, current or previous with a smoking history of ≥ 10 pack years
B: Inclusion Criteria:

* diagnosis of mild to moderate asthma, FEV1 ³ 60% of predicted normal values pre-bronchodilator, daily use of inhaled GCS during the last 3 months

Exclusion Criteria:

* Regular need of \>4 inhalations of a short-acting b2-agonist/day, known or suspected hypersensitivity to any of the investigational drugs or inhaled lactose, use of any b-blocking agent, having smoked ³10 pack-years
C: Inclusion Criteria:

* Physician-diagnosed asthma for at least previous 12 months.
* Able to perform reproducible spirometry.
* Baseline FEV1≥70% of predicted.
* Asthma confirmed either by:

  * Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR
  * Methacholine PC20 ≤ 16 mg/ml
* At least 1 of the following indications for chronic controller therapy:

  * Asthma Symptoms \> 2 days/week OR
  * Nocturnal Asthma Symptoms \> 2 nights/month OR
  * Short-acting beta-agonist use for symptom control \> 2 days/week
* 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.
* Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.

Exclusion Criteria:

* Chronic inhaled or oral corticosteroid therapy.
* Use of inhaled or oral corticosteroid therapy within 6 weeks.
* New allergen immunotherapy within the past 3 months or anticipated changes to an ongoing immunotherapy regimen.
* Use of omalizumab within 3 months.
* History of:

  * bladder-neck obstruction, urinary retention or benign prostatic hyperplasia
  * narrow angle glaucoma
  * significant cardiovascular disorders and arrhythmias
  * life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years
* Respiratory tract infection within past 6 weeks.
* History of smoking within the past 1 year, or \> 10 pack-years total if ≥ 18 years of age, or \> 5 pack-years total if \< 18 years of age.
* Chronic diseases or medical conditions (other than asthma) that could put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system, or immunodeficiency.
D: Inclusion Criteria:

* Written signed and dated informed consent obtained.
* Male or female patients aged ≥ 18 years.
* A positive reversibility test
* Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month)
* Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting beta2 agonists (LABA) at a constant dose for two months before screening visit
* Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007) in the last month before screening visit
* Forced expiratory volume in the first second (FEV1) ≥ 60% of predicted for the patient normal value.
* Non smokers or ex-smokers

Exclusion Criteria:

* Pregnant or nursing (lactating) women. Women of child-bearing potential UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/mL or are using one or more of acceptable methods of contraception
* Body Mass Index (BMI) \> 34 kg/m2.
* Patient with lower respiratory tract infections affecting the patient's asthma within 30 days of the screening visit.
* Use of systemic steroids in the last month.
* Patients with other lung diseases such as COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder.
* Patients who have an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease.
* Clinically relevant laboratory abnormalities
* Patients who have an abnormal QTcF interval value
* Intolerance or contra-indication to treatment with beta2-agonists and/or ICS or allergy to any component of the study treatments.
* Patients treated with slow-release corticosteroids in the 3 months prior to screening visit.
* Patients being treated with anti-IgE antibodies.
* Patients treated with LABA or ICS/LABA fixed combination in the 24h before screening visit
* Severe asthma exacerbation in the last month before screening visit

Answer: B