Characterization of Placebo Responses in Stable Asthma

NCT01143688 | Completed Results

• 3 other identifiers: 2005P-002045R21AT002793-01K24AT004095
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma Placebo Effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (3)

albuterol inhaler

ACTIVE COMPARATOR

albuterol

Drug: albuterol

placebo inhaler

PLACEBO COMPARATOR

placebo

Drug: placebo inhaler

placebo acupuncture

PLACEBO COMPARATOR

placebo

Procedure: placebo acupuncture

Interventions

albuterol DRUG

albuterol inhaler

placebo inhaler DRUG

placebo inhaler

placebo acupuncture PROCEDURE

placebo acupuncture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• uncontrolled asthma

You may not qualify if:

• no bronchodilator response

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Brigham & women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Limitations and Caveats

The subjective scale did not encompass worsening of symptoms. Only studied acute asthmatic response, not chronic. Used single objective measure (FEV1) and single subjective measure. Did not assess subjective symptoms before each visit's intervention

Results Point of Contact

• Title: Michael E. Wechsler M.D.
• Organization: National Jewish Health

wechslerm@NJHealth.org

617-285-4987

Study Officials

• Michael Wechsler, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael Wechsler, MD

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 14, 2010
• Study Start: January 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: March 30, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-03

Locations

US (1)