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

NCT01939951 | Unknown Phase 4

• 1 other identifier: 0010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to find out if AES ( Activation Energy Serum) , a blend of natural minerals , is effective and safe for the treatment of asthma if taken for 4 weeks . The efficacy will be scientifically tested by symptoms scores, questionnaires, breathing and blood tests.

Conditions

Mild to Moderate Persistent Asthma

Keywords

Asthma; Persistent

Outcome Measures

Primary Outcomes (1)

• Morning FEV1

  Morning forced expiratory volume in 1 second. This is an assessment of asthma status and severity

  4 weeks

Secondary Outcomes (1)

• Symptom scores

  Daily for 4 weeks

Other Outcomes (2)

• Fractional exhaled nitric oxide ( FeNO)

  weekly for 4 weeks

• Blood eosinophil count

  weekly for 4 weeks

Study Arms (2)

Activation Energy Serum

ACTIVE COMPARATOR

Activation Energy Serum 7 or 21 drops twice daily for 4 weeks

Dietary Supplement: Activation Energy Serum

Placebo

PLACEBO COMPARATOR

sugar pill

Dietary Supplement: Activation Energy Serum

Interventions

Activation Energy Serum DIETARY_SUPPLEMENT

7 drops or 21 drops twice daily

Also known as: AES

Activation Energy Serum; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained before any assessment is performed
• Males and females of any race who are between 18 and 65 years old at the time informed consent is obtained.
• Physician diagnosis of asthma, as per NIH ( National Institutes of Health) guidelines, for at least 3 months.
• Patients with a pre-bronchodilator FEV1 ( forced expiratory volume in 1 second) value of 40% to 90% of individual predicted value at screening and at randomization, and the value at the randomization should be within 15% of the screening FEV1. The results of spirometry should meet the ATS/ERS ( American Thoracic Society/European Respiratory Society) criteria for acceptability and repeatability.
• \. Patients who are demonstrated to have reversible airway obstruction or airways hyper- reactivity or have shown either of such responses in previous test(s) within the last year.
• Reversible airway obstruction is defined as an increase of ≥12% and ≥200 ml in FEV1 over the patient's pre-bronchodilator value in litres within 10-15 minutes after inhaling a total of 360 µg of albuterol or 400 µg salbutamol via MDI (metered dose inhaler) (reversibility test). The administration of albuterol or salbutamol for the reversibility test is to be within 30 minutes after pre-bronchodilator spirometry.
• \. An ACQ ( Asthma Control Questionnaire) score ≥ 1.5 at randomization. 8. Total daily asthma symptom score of \> 4 on 3 out of 7 days between the Screening and Randomization Visit.
• \. A fractional exhaled nitric oxide (FeNO) level of \> 25 ppb 9. Blood eosinophil count of \> 200 /mm3.

You may not qualify if:

• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half- lives of enrollment, whichever is longer.
• History of hypersensitivity to any AES products.
• 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.
• 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).
• \. 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.).
• \. 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.
• \. 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.
• \. Patients who have been hospitalized due to their asthma, or that have required treatment with systemic steroids, within 6 weeks of the screening visit.
• \. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening .
• \. Current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10 pack years.

Sponsors & Collaborators

• California Allergy and Asthma Medical Group, Inc.: lead

Study Sites (1)

California Allergy and Asthma Medical Group

Los Angeles, California, 90025, United States

Location

Related Links

• Research site website

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Sheldon L Spector, MD

CONTACT

310-966-9022; spector@calallergy.com

Ricardo A Tan, MD

CONTACT

310-966-9022; ricardoatan@aol.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2013
• First Posted: September 11, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 11, 2013

Record last verified: 2013-09

Locations

US (1)