Asthma Clinical Trial
Official title:
Clinical Assessment of Acupuncture for the Treatment of Asthma: A Randomized, Multicenter, Double-blind, Parallel-group Controlled Trial
The purpose of this study is to assess whether acupuncture is effective in the treatment of chronic asthma.
Asthma is a common chronic disease worldwide with an estimated 300 million affected
individuals. In analyses of economic burden of asthma, apart from direct medical costs
including hospital admissions and cost of medications, indirect, non-medical costs such as
time lost from work account for a considerable part. For all but the most severe patients,
the ultimate goal is to prevent symptoms, minimize morbidity from acute episodes, and
prevent functional and psychological morbidity to provide a near healthy lifestyle. Although
the symptoms can be controlled by drug treatment in most patients, effective low-risk,
non-drug approaches such as acupuncture could constitute a significant advance in asthma
management. The purpose of this study is to assess whether acupuncture is effective in the
treatment of chronic asthma.
There is a 1-week screening period(-1 week) during which participants will be monitored
while they use an albuterol inhaler as needed. Study visits will occur at weeks 0(Baseline),
weeks 3, weeks 6. Participants will undergo a physical examination, lung function, blood and
urine collection. At the Weeks 0 study visit, participants will be randomly assigned to one
of the following two groups for 6 weeks of treatment:
- Group 1 will receive verum acupuncture treatment once every two days plus albuterol as
needed, prednisone for exacerbation
- Group 2 will receive sham acupuncture treatment once every two days plus albuterol as
needed, prednisone for exacerbation
Study visits will occur at Weeks 0, 3, 6. A physical examination, blood collection, and lung
function will occur at selected visits. Questionnaires to assess asthma control and quality
of life will also be completed. Throughout the study, participants will record asthma
symptoms and medication usage in a daily diary.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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