Mild to Moderate Persistent Asthma Clinical Trial
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.
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) .
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00890877 -
OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma
|
Phase 2 |