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
  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: 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • asthma symptoms [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • uncontrolled asthma

Exclusion Criteria:

  • no bronchodilator response
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143688

Locations
United States, Massachusetts
Brigham & women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Michael Wechsler, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Michael Wechsler, MD, Brigham &Women's Hospital
ClinicalTrials.gov Identifier: NCT01143688     History of Changes
Other Study ID Numbers: 2005P-002045, R21AT002793-01, K24AT004095
Study First Received: June 10, 2010
Last Updated: June 11, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014