NEED PROOF

Ages: 18-80
Gender: Any

Study Description:
This is a clinical research study to test the safety and effectiveness of an investigational injectable medication as an add-on therapy for mild to moderate asthma. Participants will receive either the investigational injectable medication or placebo once every 4 weeks, in addition to an approved asthma medication taken twice daily, for approximately 1 year. Additional procedures include vital signs, ECGs, lung function tests, physical examinations, lab sample collection, questionnaire completion and e-Diary entries. Total participation will last approximately 1 year and 3 months with 18 office visits throughout the study. Eligibility for the study will be determined by the study doctor following one or more in-person screening visits to the clinic. Trial-related procedures and study medication will be provided at no cost. 


Questions/Answers to Screener:
Have you been diagnosed with asthma by a physician for 1 year or longer? (ANSWER: YES)

Do you use a corticosteroid inhaler (ICS) (with or without LABA) to treat your asthma every day for at least 1 month?
Examples include but are not limited to:
- Advair Diskus 
- Asmanex 
- Symbicort 
- Flovent HFA 
- Qvar 
[PATIENT NOTE]:
Long-acting muscarinic antagonists (LAMA) or other controller inhalers such as albuterol in addition to ICS/LABA are exclusionary. Current use of budesonide or formoterol doesn’t have to be used daily.
(ANSWER: YES)

In the past month, have you used a low-dose ICS-LABA inhaler (like budesonide/formoterol) only when needed and used it at least 7 times each week?
(ANSWER: YES)

In the past year, have you experienced 1 or more asthma exacerbations (a worsening of asthma symptoms) that required:  
- treatment with corticosteroids for at least 3 days OR 
- a visit to a doctor, emergency room or hospitalization?
(ANSWER: YES)

Have you been diagnosed with a chronic lung disease other than asthma?  
Examples include but are not limited to:  
- Cystic Fibrosis
- Pulmonary Fibrosis 
- Chronic Obstructive Pulmonary Disease (COPD) 
- Emphysema
(ANSWER: NO)

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