Characterization of Placebo Responses in Stable Asthma

Mass General Brigham

Status: Completed

Conditions: Asthma Placebo Effects

Treatments: Drug: placebo inhaler; Drug: albuterol; Procedure: placebo acupuncture

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01143688

R21AT002793-01 (U.S. NIH Grant/Contract)

2005P-002045

K24AT004095 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• uncontrolled asthma

Exclusion criteria

• no bronchodilator response

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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39 participants in 3 patient groups, including a placebo group

albuterol inhaler

Active Comparator group

Description:

albuterol

Treatment:

Drug: albuterol

placebo inhaler

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo inhaler

placebo acupuncture

Placebo Comparator group

Description:

placebo

Treatment:

Procedure: placebo acupuncture