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Characterization of Placebo Responses in Stable Asthma

This study has been completed.
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
Brigham and Women's Hospital Identifier:
First received: June 10, 2010
Last updated: June 11, 2010
Last verified: June 2010

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: Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 Brigham and Women's Hospital:

Primary Outcome Measures:
  • mean change in peak Spirometric forced expiratory volume in 1 second (FEV1)at 20 minute intervals post intervention

Secondary Outcome Measures:
  • asthma symptoms
    subjective improvement in asthma symptoms on a visual analog scale

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 Drug: albuterol
Placebo Comparator: placebo inhaler Drug: placebo inhaler
Placebo Comparator: placebo acupuncture Procedure: placebo acupuncture


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

Inclusion Criteria:

  • uncontrolled asthma

Exclusion Criteria:

  • no bronchodilator response
  Contacts and Locations
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Please refer to this study by its identifier: NCT01143688

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)
Principal Investigator: Michael Wechsler, MD Brigham and Women's Hospital
  More Information

Responsible Party: Michael Wechsler, MD, Brigham &Women's Hospital 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
Last Updated: June 11, 2010

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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 processed this record on March 27, 2017