Characterization of Placebo Responses in Stable Asthma

March 29, 2017 updated by: Michael Wechsler, MD, Brigham and Women's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women'S Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • uncontrolled asthma

Exclusion Criteria:

  • no bronchodilator response

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: albuterol inhaler
albuterol
Drug: albuterol
PLACEBO_COMPARATOR: placebo inhaler
placebo
Drug: placebo inhaler
PLACEBO_COMPARATOR: placebo acupuncture
placebo
Procedure: placebo acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

January 1, 2009

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

June 10, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (ESTIMATE)

June 14, 2010

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005P-002045
  • K24AT004095 (NIH)
  • R21AT002793-01 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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