Mild to Moderate Persistent AsthmaPhase 4NCT01939951
Efficacy and Safety of Activation Energy Serum (AES) Versus Placebo in Persistent Asthma.
A Phase 4 study testing Activation Energy Serum in people with Mild to Moderate Persistent Asthma, run by California Allergy and Asthma Medical Group, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Persistent Asthma
- What is being tested?
- Activation Energy Serum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients eligible for inclusion in this study should fulfill all of the following criteria:
- 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.
- 6. 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.
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- 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.
- 7. 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.
- 9. A fractional exhaled nitric oxide (FeNO) level of > 25 ppb 9. Blood eosinophil count of > 200 /mm3.
Who cannot join
- 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).
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Allergy and Asthma Medical Group
Los Angeles, California, 90025
Sheldon L Spector, MD, 310-966-9022, spector@calallergy.com
Ricardo A Tan, MD, 310-966-9022, ricardoatan@aol.com
About this study
Official title: A Double-Blind, Randomized, Parallel Group, Placebo-controlled Study to Compare the Efficacy and Safety of Activation Energy Serum (AES) Versus Placebo on Patients With Mild to Moderate Persistent Asthma.
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.
Read the detailed description
The primary objective of this study will be to compare the overall efficacy and safety of AES ( Activation Energy Serum) by demonstrating a clinically significant improvement in morning FEV1 in patients with mild to moderate persistent asthma treated with 2 doses of AES for 4 weeks compared to placebo.
The secondary objectives will be to evaluate the effect of AES on a) clinical symptoms by symptom scores and the Asthma Control Questionnaire ( ACQ) , b) fractional exhaled nitric oxide ( FeNO) , c) blood eosinophil count and other biomarkers , and d) quality of life through the Asthma Quality of Life Questionnaire ( AQLQ) .
- Conditions
- Mild to Moderate Persistent Asthma
- Being tested
- Activation Energy Serum
- Keywords
- Asthma, Persistent
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activation Energy SerumDietary supplement
Also called AES
7 drops or 21 drops twice daily
| Study group | Role | What they receive |
|---|---|---|
| Activation Energy Serum | Active comparator | Activation Energy Serum 7 or 21 drops twice daily for 4 weeks Receives: Dietary Supplement: Activation Energy Serum |
| Placebo | Placebo comparator | sugar pill Receives: Dietary Supplement: Activation Energy Serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morning FEV1
Morning forced expiratory volume in 1 second. This is an assessment of asthma status and severity
Measured: 4 weeks
Secondary outcomes (1)
Symptom scores
Patients will provide personal score for their asthma symptoms ( 0-3) 0-Absent, none present
1-Mild, clearly present but minimal awareness that is bothersome but tolerable 2 -Moderate, definite awareness which is bothersome but tolerable 3 - Severe, hard to tolerate, interfere with activities of daily living and/or sleeping.
Measured: Daily for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Persistent AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Allergy and Asthma Medical Group, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939951
- Sponsor's protocol ID
- 0010
- Status last verified
- Sep 2013
- First submitted
- 7 Sep 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel Group, Placebo-controlled Study to Compare the Efficacy and Safety of Activation Energy Serum (AES) Versus Placebo on Patients With Mild to Moderate Persistent Asthma.
- ClinicalTrials.gov ID
- NCT01939951
- Acronym / sponsor ID
- 0010
- Conditions
- Mild to Moderate Persistent Asthma
- Keywords
- Asthma, Persistent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- California Allergy and Asthma Medical Group, Inc.University, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study will be to compare the overall efficacy and safety of AES ( Activation Energy Serum) by demonstrating a clinically significant improvement in morning FEV1 in patients with mild to moderate persistent asthma treated with 2 doses of AES for 4 weeks compared to placebo.
The secondary objectives will be to evaluate the effect of AES on a) clinical symptoms by symptom scores and the Asthma Control Questionnaire ( ACQ) , b) fractional exhaled nitric oxide ( FeNO) , c) blood eosinophil count and other biomarkers , and d) quality of life through the Asthma Quality of Life Questionnaire ( AQLQ) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activation Energy Serum | Active comparator | Dietary Supplement: Activation Energy SerumActivation Energy Serum 7 or 21 drops twice daily for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Activation Energy Serumsugar pill |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients eligible for inclusion in this study should fulfill all of the following criteria:
- 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.
Key exclusion criteria (24 listed)
- 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).
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activation Energy SerumAlso: AES7 drops or 21 drops twice daily | Dietary supplement | Activation Energy Serum, Placebo |
Primary outcome
Morning FEV1
Time frame: 4 weeks
Morning forced expiratory volume in 1 second. This is an assessment of asthma status and severity
1 secondary outcome
Symptom scores
Time frame: Daily for 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2013.
- Research site websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Activation Energy Serum in people with Mild to Moderate Persistent Asthma, run by California Allergy and Asthma Medical Group, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheldon L Spector, MD (310-966-9022, spector@calallergy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morning FEV1 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2013.