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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT002793-01 | U.S. NIH Grant/Contract | View source | |
| K24AT004095 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| albuterol inhaler | Active Comparator | albuterol |
|
| placebo inhaler | Placebo Comparator | placebo |
|
| placebo acupuncture | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| albuterol | Drug |
| ||
| placebo inhaler |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Wechsler, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & women's Hospital | Boston | Massachusetts | 02115 | United States |
79 patients completed questionnaires, 46 patients had reversibility and were randomized, and 39 completed the whole trial. The data was solely based on the 39 subjects who completed the entire trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Each study participant was randomized to a specific random sequence of interventions for visits 1-4 (e.g. first inhaled bronchodilator, then inhaled placebo, then sham acupuncture, then no intervention administered 3-7 days apart, or first sham acupuncture, then inhaled bronchodilator, then no intervention, then inhaled placebo administered 3-7 days apart, or any other combination of these four interventions in any order). This process was repeated for visits 5-8 and again for visits 9-12. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Each patient went through each treatment arm (albuterol, placebo inhaler, placebo acupuncture, and no-intervention) once in block 1, then again in block 2, and again in block 3, for a total of 12 interventions of the course of the study. | Posted | Mean | Standard Error | percentage change in FEV1 | 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. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Albuterol Inhaler | Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area. |
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The subjective scale did not encompass worsening of symptoms. Only studied acute asthmatic response, not chronic. Used single objective measure (FEV1) and single subjective measure. Did not assess subjective symptoms before each visit's intervention
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael E. Wechsler M.D. | National Jewish Health | 617-285-4987 | wechslerm@NJHealth.org |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| placebo acupuncture | Procedure |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.
Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
| OG001 | Placebo Inhaler | Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area. |
| OG002 | Placebo Acupuncture | Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture. |
| OG003 | No-intervention Control | Subjects will be instructed that they will receive no interventions on this visit. Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area. |
|
|
| Secondary | 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. | Posted | Mean | Standard Error | 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. |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Placebo Inhaler | Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area. | 0 | 39 | 0 | 39 |
| EG002 | Placebo Acupuncture | Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture. | 0 | 39 | 0 | 39 |
| EG003 | No-intervention Control | Subjects will be instructed that they will receive no interventions on this visit. Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area. | 0 | 39 | 0 | 39 |
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| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |