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Characterization of Placebo Responses in Stable Asthma

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Michael Wechsler, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01143688
First received: June 10, 2010
Last updated: March 29, 2017
Last verified: March 2017
Results First Received: December 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Asthma Placebo Effects
Interventions: Drug: albuterol
Drug: placebo inhaler
Procedure: placebo acupuncture

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    All Study Participants
STARTED   39 
COMPLETED   39 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Overall Study No text entered.

Baseline Measures
   Overall Study 
Overall Participants Analyzed 
[Units: Participants]
 46 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.5  (17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      37  80.4% 
Male      9  19.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in FEV1   [ 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. ]

2.  Secondary:   Asthma 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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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


  More Information
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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
e-mail: wechslerm@NJHealth.org



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 ( US NIH Grant/Contract Award Number )
K24AT004095 ( US NIH Grant/Contract Award Number )
Study First Received: June 10, 2010
Results First Received: December 2, 2016
Last Updated: March 29, 2017