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Characterization of Placebo Responses in Stable Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01143688
First Posted: June 14, 2010
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Michael Wechsler, MD, Brigham and Women's Hospital
  Purpose

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.


Condition Intervention
Asthma Placebo Effects Drug: albuterol Drug: placebo inhaler Procedure: placebo acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Characterization of Placebo Responses in Stable Asthma

Resource links provided by NLM:


Further study details as provided by Michael Wechsler, MD, Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 39
Study Start Date: January 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: albuterol inhaler
albuterol
Drug: albuterol
Placebo Comparator: placebo inhaler
placebo
Drug: placebo inhaler
Placebo Comparator: placebo acupuncture
placebo
Procedure: placebo acupuncture

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • uncontrolled asthma

Exclusion Criteria:

  • no bronchodilator response
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143688


Locations
United States, Massachusetts
Brigham & women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Michael Wechsler, MD Brigham and Women's Hospital
  More Information

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
Last Verified: March 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action


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