Characterization of Placebo Responses in Stable Asthma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01143688
First received: June 10, 2010
Last updated: June 11, 2010
Last verified: June 2010

June 10, 2010
June 11, 2010
January 2005
January 2009   (final data collection date for primary outcome measure)
mean change in peak Spirometric forced expiratory volume in 1 second (FEV1)at 20 minute intervals post intervention [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01143688 on ClinicalTrials.gov Archive Site
asthma symptoms [ Designated as safety issue: No ]
subjective improvement in asthma symptoms on a visual analog scale
Same as current
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
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma Placebo Effects
  • Drug: albuterol
  • Drug: placebo inhaler
  • Procedure: placebo acupuncture
  • Active Comparator: albuterol inhaler
    Intervention: Drug: albuterol
  • Placebo Comparator: placebo inhaler
    Intervention: Drug: placebo inhaler
  • Placebo Comparator: placebo acupuncture
    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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01143688
2005P-002045, R21AT002793-01, K24AT004095
No
Michael Wechsler, MD, Brigham &Women's Hospital
Brigham and Women's Hospital
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Michael Wechsler, MD Brigham and Women's Hospital
Brigham and Women's Hospital
June 2010

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