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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
June 10, 2010
March 29, 2017
January 2005
January 2009   (Final data collection date for primary outcome measure)
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. ]
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.
mean change in peak Spirometric forced expiratory volume in 1 second (FEV1)at 20 minute intervals post intervention
Complete list of historical versions of study NCT01143688 on ClinicalTrials.gov Archive Site
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. ]
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.
Asthma Symptoms
subjective improvement in asthma symptoms on a visual analog scale
Not Provided
Not Provided
 
Characterization of Placebo Responses in Stable Asthma
Characterization of Placebo Responses in Stable Asthma

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Asthma Placebo Effects
  • Drug: albuterol
  • Drug: placebo inhaler
  • Procedure: placebo acupuncture
  • Active Comparator: albuterol inhaler
    albuterol
    Intervention: Drug: albuterol
  • Placebo Comparator: placebo inhaler
    placebo
    Intervention: Drug: placebo inhaler
  • Placebo Comparator: placebo acupuncture
    placebo
    Intervention: Procedure: placebo acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
January 2009
January 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • uncontrolled asthma

Exclusion Criteria:

  • no bronchodilator response
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01143688
2005P-002045
R21AT002793-01 ( US NIH Grant/Contract Award Number )
K24AT004095 ( US NIH Grant/Contract Award Number )
No
Not Provided
Not Provided
Not Provided
Michael Wechsler, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Michael Wechsler, MD Brigham and Women's Hospital
Brigham and Women's Hospital
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP