Efficacy and Safety of Activation Energy Serum (AES) Versus Placebo in Persistent Asthma.

Exclusion Criteria

• •1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half- lives of enrollment, whichever is longer.
• •2. History of hypersensitivity to any AES products.
• •3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• •4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG ( human chorionic gonadotropin) laboratory test (\> 5 mIU( milli international unit)/mL).
• •6\. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use effective contraception during the study and for 4 days (5 half-lives) after treatment. Effective contraception is defined as either:
• •Barrier method: c) Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. Spermicides alone are not a barrier method of contraception and should not be used alone. The following methods are considered more effective than the barrier method and are also acceptable:
• •Total abstinence: When this is in line with the preferred and usual lifestyle of the subject. \[Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\].
• •Female sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
• •Male partner sterilization. \[For female study subjects, the vasectomised male partner should be the sole partner for that patient\]
• •Use of established, oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD) or intrauterine system (IUS) 7. Patients with serious co-morbidities including uncontrolled diabetes (HbA1c ≥8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary disease or emphysema or other conditions characterised by eosinophilia and pulmonary symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.).
• •8\. Acute illness other than asthma at the start of the study. 9. History of life-threatening asthma, including a history of significant hypercarbia (pCO2\>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma.
• •10\. History of alcohol or other substance abuse. 11. Patients who have had a respiratory tract infection within 2 weeks of the screening visit. Patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date.
• •12\. Patients who have been hospitalized due to their asthma, or that have required treatment with systemic steroids, within 6 weeks of the screening visit.
• •13\. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening .
• •14\. Current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10 pack years.
• •15\. Patients with a body mass index (BMI) \< 17 or \> 40 kg/m2. 16. Patients receiving or likely to require treatment during the study with any prohibited asthma related medications of the classes or groups listed in Table 5-3.
• •17\. Patients on maintenance immunotherapy who either began their immunotherapy regimen or had a clinically relevant change to their immunotherapy within 1 month prior to granting informed consent. Patients on stable maintenance immunotherapy for at least one month prior to Visit 1 can be enrolled.
• •19\. Patients who have been previously randomized into this study. 20. Who are unable to perform spirometry ,peak flow measurements, fractional exhaled nitric oxide , complete a patient diary or complete questionnaires as required by the protocol.
• •21\. With any medical or mental condition that, in the investigators opinion, renders the patient unable to understand the nature, scope, and possible consequences of the study.
• •22\. Who are unable/unwilling to take 7 drops twice per day, who are unable to use an inhaler or who are unlikely to comply with the protocol.
• •23\. Use of immunosuppressive medication (except inhaled and topical corticosteroids) within 30 days before randomization into the study. 24. A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject's verbal report.
• •25\. A positive human immunodeficiency virus test or is taking anti-retroviral medications, as determined by medical history and/or subject's verbal report.
• •26\. History of any known immunodeficiency disorder. 27. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of study results.
• •28\. Patients who, in the opinion of the investigator, are unsuitable to take part in this study.