Asthma Placebo EffectsNCT01143688

Characterization of Placebo Responses in Stable Asthma

A study testing albuterol in people with Asthma Placebo Effects, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Asthma Placebo Effects
What is being tested?: albuterol
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 39 participants
Where: 1 siteUnited States
Study dates: Jan 2005to Jan 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

uncontrolled asthma

Who cannot join

no bronchodilator response

Trial locations and contacts

1 site in 1 country.

United States1 site

Brigham & women's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

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
Being tested: albuterol, placebo inhaler, placebo acupuncture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

albuterolDrug
placebo inhalerDrug
placebo acupunctureProcedure or surgery

Study groups in NCT01143688
Study group	Role	What they receive
albuterol inhaler	Active comparator	albuterol Receives: Drug: albuterol
placebo inhaler	Placebo comparator	placebo Receives: Drug: placebo inhaler
placebo acupuncture	Placebo comparator	placebo Receives: Procedure: placebo acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Jan 2009

First posted14 Jun 2010 (estimated)
Study startJan 2005
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Asthma Placebo EffectsStudies of the same condition, open and under way.
More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01143688
Sponsor's protocol ID: 2005P-002045
Other IDs: R21AT002793-01, K24AT004095
Status last verified: Mar 2017
First submitted: 10 Jun 2010
Last updated: 30 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Asthma Placebo Effects trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization of Placebo Responses in Stable Asthma
ClinicalTrials.gov ID: NCT01143688
Acronym / sponsor ID: 2005P-002045
Conditions: Asthma Placebo Effects
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Jan 2005
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 14 Jun 2010 (estimated)
Results: Posted 30 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators hypothesize that different placebos will have different effects on subjective and objective asthma outcomes compared with actual therapy and natural history. .

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
albuterol inhaler	Active comparator	Drug: albuterolalbuterol
placebo inhaler	Placebo comparator	Drug: placebo inhalerplacebo
placebo acupuncture	Placebo comparator	Procedure: placebo acupunctureplacebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

uncontrolled asthma

Key exclusion criteria (1 listed)

no bronchodilator response

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
albuterol	Drug	albuterol inhaler
placebo inhaler	Drug	placebo inhaler
placebo acupuncture	Procedure or surgery	placebo acupuncture

Primary outcome

Change in FEV1
Time frame: 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.

1 secondary outcome

Asthma Symptoms
Time frame: 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.

Results and safety

Results posted to the registry on 30 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Study Participants	39	39

Primary outcome: Change in FEV1

Time frame: 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.. Mean (Standard Error). Unit: percentage change in FEV1

Measure	Albuterol Inhaler n = 39	Placebo Inhaler n = 39	Placebo Acupuncture n = 39	No-intervention Control n = 39
Value	20.1 (1.6)	7.5 (1.0)	7.3 (0.8)	7.1 (0.8)

Population analysed: Each patient went through each treatment arm (albuterol, placebo inhaler, placebo acupuncture, and no-intervention) once in block 1, then again in block 2, and again in block 3, for a total of 12 interventions of the course of the study.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Albuterol Inhaler	0 of 39 (0%)	0 of 39 (0%)	Not reported
Placebo Inhaler	0 of 39 (0%)	0 of 39 (0%)	Not reported
Placebo Acupuncture	0 of 39 (0%)	0 of 39 (0%)	Not reported
No-intervention Control	0 of 39 (0%)	0 of 39 (0%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma Placebo Effects

RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
RecruitingPhase 1
Evaluation of Safety, Side Effects, and How the Drug, Inhaled CHF10136, Is Absorbed, Modified and Removed From the Body in Healthy Adults and Adults With Asthma
Asthma, Healthy Volunteers
Active, not recruitingPhase 4
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
Asthma
RecruitingPhase 4
Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma
Asthma
Not yet recruitingPhase 2
Effect of Linvemastat in Patients With Partially Controlled Asthma (syMMPonia)
Asthma (Diagnosis), Pulmonary Function

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Wechsler, MD principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing albuterol in people with Asthma Placebo Effects, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in FEV1 (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01143688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.