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Trial record 18 of 58344 for:    Placebo

Characterization of Placebo Responses in Stable Asthma

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ClinicalTrials.gov Identifier: NCT01143688
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Michael Wechsler, MD, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma Placebo Effects
Interventions Drug: albuterol
Drug: placebo inhaler
Procedure: placebo acupuncture
Enrollment 39
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title Overall Study
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
41.5  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
37
  80.4%
Male
9
  19.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  23.9%
White
28
  60.9%
More than one race
0
   0.0%
Unknown or Not Reported
7
  15.2%
1.Primary Outcome
Title Change in FEV1
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Albuterol Inhaler Placebo Inhaler Placebo Acupuncture No-intervention Control
Hide Arm/Group Description:

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.

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.
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.

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.

Overall Number of Participants Analyzed 39 39 39 39
Mean (Standard Error)
Unit of Measure: percentage change in FEV1
20.1  (1.6) 7.5  (1.0) 7.3  (0.8) 7.1  (0.8)
2.Secondary Outcome
Title Asthma Symptoms
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Albuterol Inhaler Placebo Inhaler Placebo Acupuncture No-intervention Control
Hide Arm/Group Description:

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.

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.
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.

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.

Overall Number of Participants Analyzed 39 39 39 39
Mean (Standard Error)
Unit of Measure: percent change in symptoms
50  (3.75) 45  (3.75) 46  (3.75) 21  (3.45)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol Inhaler Placebo Inhaler Placebo Acupuncture No-intervention Control
Hide Arm/Group Description

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.

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. 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.

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.

All-Cause Mortality
Albuterol Inhaler Placebo Inhaler Placebo Acupuncture No-intervention Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol Inhaler Placebo Inhaler Placebo Acupuncture No-intervention Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%)   0/39 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Albuterol Inhaler Placebo Inhaler Placebo Acupuncture No-intervention Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%)   0/39 (0.00%)   0/39 (0.00%) 
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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Michael E. Wechsler M.D.
Organization: National Jewish Health
Phone: 617-285-4987
Responsible Party: Michael Wechsler, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01143688     History of Changes
Other Study ID Numbers: 2005P-002045
R21AT002793-01 ( U.S. NIH Grant/Contract )
K24AT004095 ( U.S. NIH Grant/Contract )
First Submitted: June 10, 2010
First Posted: June 14, 2010
Results First Submitted: December 2, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017