Characterization of Placebo Responses in Stable Asthma

Study Overview
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Brief Summary
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The investigators hypothesize that different placebos will have different effects on subjective and objective asthma outcomes compared with actual therapy and natural history. . Subjects with asthma are randomly treated with placebo inhaler, placebo acupuncture, albuterol inhaler, or no treatment in random order, on three different occasions each. At each of the 12 visits, spirometry is performed repeatedly over 2 hours. Maximum FEV1 achieved and an 11-point, self-reported scale of improvement are examined.

Official Title
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Characterization of Placebo Responses in Stable Asthma

Conditions
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Asthma Placebo Effects

Intervention / Treatment
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* Drug: albuterol
* Drug: placebo inhaler
* Procedure: placebo acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: uncontrolled asthma Exclusion Criteria: no bronchodilator response

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: albuterol inhaler<br>albuterol | Drug: albuterol<br> <br> |
| Placebo Comparator: placebo inhaler<br>placebo | Drug: placebo inhaler<br> <br> |
| Placebo Comparator: placebo acupuncture<br>placebo | Procedure: placebo acupuncture<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FEV1 | The baseline FEV1 (before treatment) was subtracted from the maximum FEV1 recorded during the 2 h period following treatment. This difference value was then converted into percent improvement by dividing by baseline FEV1 and multiplying by 100. Each treatment was given 3 times to each patient, so we averaged the 3 values to yield the mean percent change in FEV1 for each condition. | FEV1 was assessed every 20 minutes for 2 hours at each visit. There were 4 visits in each block each visit separated by 3-7 days. There were three blocks each block separated by 3-7 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Symptoms | Subjective change in asthma symptoms on a visual-analogue scale with scores ranging from 0 (no positive change) to 10 (complete positive change). These subjective responses were then converted to percent change during the 2 hours by multiplying each score by 10. Each of these individual subject scores were then averaged to produce an average percent change in symptoms. | Assesed over 2 hours during each visit. There were 4 visits in each block each visit separated by 3-7 days. There were three blocks each block separated by 3-7 days. |