N/A
N=39
Characterization of Placebo Responses in Stable Asthma
Asthma Placebo Effects
Bottom Line
View on ClinicalTrials.gov: NCT01143688 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Change in FEV1 — 20.1; 7.5; 7.3; 7.1 percentage change in FEV1
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- albuterol (Drug); placebo inhaler (Drug); placebo acupuncture (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in FEV1 |
20.1; 7.5; 7.3; 7.1 | — |
| SECONDARY Asthma Symptoms |
50; 45; 46; 21 | — |
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.
Eligibility Criteria
Inclusion Criteria
- uncontrolled asthma
Exclusion Criteria
- no bronchodilator response
Data sourced from ClinicalTrials.gov (NCT01143688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.