Characterization of Placebo Responses in Stable Asthma

Not Applicable

Completed

• Conditions: Asthma Placebo Effects
• Interventions: Drug: placebo inhaler; Procedure: placebo acupuncture; Drug: albuterol

• Registration Number: NCT01143688
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2010-06-10
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Results First Submitted: 2016-12-02
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-29
• Last Update Submitted: 2017-03-29
• Results First Posted: 2017-03-30
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• uncontrolled asthma

Exclusion Criteria

• no bronchodilator response

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo inhaler	placebo inhaler	placebo
placebo acupuncture	placebo acupuncture	placebo
albuterol inhaler	albuterol	albuterol

Primary Outcome Measures

Name	Time	Method
Change in FEV1	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.

Secondary Outcome Measures

Name	Time	Method
Asthma 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.	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.

Trial Locations

Locations (1)

Brigham & women's Hospital; 🇺🇸 Boston, Massachusetts, United States