Characterization of Placebo Responses in Stable Asthma

NCT ID: NCT01143688

Last Updated: 2017-03-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Placebo Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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albuterol inhaler

albuterol

Group Type ACTIVE_COMPARATOR

albuterol

Intervention Type DRUG

placebo inhaler

placebo

Group Type PLACEBO_COMPARATOR

placebo inhaler

Intervention Type DRUG

placebo acupuncture

placebo

Group Type PLACEBO_COMPARATOR

placebo acupuncture

Intervention Type PROCEDURE

Interventions

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albuterol

Intervention Type DRUG

placebo inhaler

Intervention Type DRUG

placebo acupuncture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* uncontrolled asthma

Exclusion Criteria

* no bronchodilator response
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael Wechsler, MD

Michael Wechsler, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Wechsler, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham & women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Study Documents

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Document Type: Publication

Active Albuterol or Placebo, Sham Acupuncture, or No Intervention in Asthma Michael E. Wechsler, M.D., John M. Kelley, Ph.D., Ingrid O.E. Boyd, M.P.H., Stefanie Dutile, B.S., Gautham Marigowda, M.B., Irving Kirsch, Ph.D., Elliot Israel, M.D., and Ted J. Kaptchuk N Engl J Med 2011; 365:119-126 July 14, 2011 DOI: 10.1056/NEJMoa1103319

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Other Identifiers

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R21AT002793-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K24AT004095

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2005P-002045

Identifier Type: -

Identifier Source: org_study_id

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