Please select the eligibility criteria that correspond to the clinical trial below.
Title: The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety and Cost-effectiveness of Azithromycin as add-on Therapy in Adult Subjects With Severe Persistent Asthma, Who Remain Inadequately Controlled Despite GINA (2006) Step 4 or 5 Therapy
Brief Summary: The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.


Options:
A: Inclusion Criteria:

1. patients who have given written informed consent
2. males or females of any race
3. 18-75 years of age
4. with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features
5. receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening
6. patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations within the previous 12 months
7. patients must be never-smokers or ex-smokers with a smoking history of ≤ 10 pack-years.

Exclusion Criteria:

1. females who are pregnant or who are breastfeeding
2. patients with severe bronchiectasis
3. patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)
4. patients with significant underlying medical conditions (e.g. infection, hematological disease, malignancy, neurologic, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
5. who are unable to perform spirometry or complete a patient diary or complete questionnaires
6. patients with known hypersensitivity to azithromycin or other macrolide antibiotics
7. patients who's heart rate corrected QT interval is prolonged
8. patients who have - in the judgement of the investigator - a clinically relevant laboratory abnormality
9. patients currently treated with macrolide antibiotics or recent macrolide treatment (in the past twelve weeks)
10. anti-IgE treatment
B: Inclusion Criteria:

* Between ages 13 - 18 years
* Prior Asthma diagnosis
* Use of a prescribed Asthma medication in the past 12 months
C: Inclusion Criteria:

* Patient's written informed consent obtained prior to any study-related procedures
* Male or female patient aged 18 years and above
* Patient with established diagnosis of asthma for at least 6 months
* Patient on maintenance therapy (Fixed dose combination ICS/LABA) with high dose of ICS
* Patient with ACT score \<20 at screening and at randomization
* Non- or ex-smoker who smoked ≤ 10 Pack-years prior to screening
* Patient must have their own Android® or iPhone operating system (IOS) smartphone
* Ability to use the pMDI device correctly

Exclusion Criteria:

* Patient with an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 to 3 month prior to screening
* Patient with a history of near-fatal asthma
* Clinically relevant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, psychiatric or any other disorder that would put the safety of the subject at risk through participation, or which would affect the analysis
* Patient not able to be compliant with the study requirements.
* Patient with a BMI \> 40
* Patient working on night shifts
* Patient participating in the clinical phase of an interventional trial or have done so within the last 30 days prior to screening.
* Patient who has an already planned major surgery or hospitalization
* Female patient who is pregnant or lactating or who plans to become pregnant in the next 4 months.
* Patient with a history of hypersensitivity to any of the components of Foster pMDI
D: Inclusion Criteria:

* Age 8 to 17
* Diagnosis of persistent asthma
* Prescribed an inhaled corticosteroid (ICS) for at least one month prior to enrollment
* Use of a pressurized metered dose inhaler (pMDI) compatible with the Cohero mHealth Herotracker (See Appendix)
* Parent/child possess a compatible smartphone (iOS 8.0 or higher)
* English or Spanish speaking

Exclusion Criteria:

* Presence of another chronic lung disease or condition such as cystic fibrosis, interstitial lung disease, chronic lung disease of prematurity, recurrent aspiration, or presence of tracheostomy
* Presence of other chronic medical condition such as congenital heart disease or immunodeficiency
* Presence of other comorbidities that, in the opinion of the investigator, will interfere with collection of study procedures, or limits life expectancy to \< 1 year
* Currently pregnant or planning to become pregnant during the trial period

Answer: A