Characterization of Placebo Responses in Stable Asthma

Asthma Placebo Effects Clinical Trial

Official title:

Characterization of Placebo Responses in Stable Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143688
• Other study ID #: 2005P-002045
• Secondary ID: R21AT002793-01K2
• Status: Completed
• Phase: N/A
• First received: June 10, 2010
• Last updated: March 29, 2017
• Start date: January 2005
• Est. completion date: January 2009

Study information

• Verified date: March 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• uncontrolled asthma

Exclusion Criteria:

• no bronchodilator response

Related Conditions & MeSH terms

• Asthma
• Asthma Placebo Effects

Intervention

Drug:
• albuterol

• placebo inhaler

Procedure:
• placebo acupuncture

Locations

Country	Name	City	State
United States	Brigham & women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FEV1	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	Asthma Symptoms	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.