AsthmaNCT01066416
Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control
A study testing Endoscopic Sinus Surgery and medical therapy in people with Asthma and Chronic Sinusitis, run by Endeavor Health at 1 site in United States.
Trial summary
It is unknown whether surgical treatment of chronic sinusitis improves asthma control in patients with poorly controlled asthma. This is a randomized trial of surgical plus medical sinus therapy versus medical therapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Sinusitis
- What is being tested?
- Endoscopic Sinus Surgery and medical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status
- Informed consent and ability to comply with study procedures
- Patients must meet inclusion criteria for both asthma and sinus disease.
- In order to qualify for the 6 week run-in, patients must have poorly controlled asthma as defined by the following criteria:
- Diagnosis of asthma confirmed either by demonstrating a positive methacholine challenge test (defined as a decrease in FEV1 by at least 20%, following administration of 8mg or less of inhaled methacholine) or a positive bronchodilator response (defined as a change from base line of >12% and at least 200ml in either FEV1 or FVC, following administration of a short-acting, inhaled bronchodilator).
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- Either:
- Asthma Control Questionnaire score > 1.5 or
- Use of inhaled rescue ß-agonist >/= 16 puffs per week (excluding use as a pre-medication for exercise; 1 nebulizer treatment = 2 puffs of inhaler) at any time during the past month or
- >1 hospitalization or unscheduled MD visit in the past 6 months for asthma symptoms or
- >1 course of oral steroid use in past 6 months or
- > 2 weeks of systemic steroids in last 6 months.
Who cannot join
- Current smokers or those with at least a 10 pack-year smoking history
- Presence of any concurrent diseases that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk
Trial locations and contacts
1 site in 1 country.
About this study
It is unknown whether surgical treatment of chronic sinusitis improves asthma control in patients with poorly controlled asthma. This is a randomized trial of surgical plus medical sinus therapy versus medical therapy alone.
- Conditions
- Asthma, Chronic Sinusitis
- Being tested
- Endoscopic Sinus Surgery, medical therapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Sinus SurgeryProcedure or surgery
medical therapyOther
Subjects will undergo surgery 6 months after randomization
| Study group | Role | What they receive |
|---|---|---|
| Medical therapy | Placebo comparator | Patients undergo surgery 6 months after randomization Receives: Other: medical therapy |
| Surgery | Experimental | Patients undergo surgery at time of randomization Receives: Procedure: Endoscopic Sinus Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionDec 2010
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066416
- Sponsor's protocol ID
- 0001
- Status last verified
- Jul 2019
- First submitted
- 9 Feb 2010
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control
- ClinicalTrials.gov ID
- NCT01066416
- Acronym / sponsor ID
- 0001
- Conditions
- Asthma, Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is unknown whether surgical treatment of chronic sinusitis improves asthma control in patients with poorly controlled asthma. This is a randomized trial of surgical plus medical sinus therapy versus medical therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical therapy | Placebo comparator | Other: medical therapyPatients undergo surgery 6 months after randomization |
| Surgery | Experimental | Procedure: Endoscopic Sinus SurgeryPatients undergo surgery at time of randomization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- In order to qualify for the 6 week run-in, patients must have poorly controlled asthma as defined by the following criteria:
- Diagnosis of asthma confirmed either by demonstrating a positive methacholine challenge test (defined as a decrease in FEV1 by at least 20%, following administration of 8mg or less of inhaled methacholine) or a positive bronchodilator response (defined as a change from base line of >12% and at least 200ml in either FEV1 or FVC, following administration of a short-acting, inhaled bronchodilator).
- Either:
Key exclusion criteria (2 listed)
- Current smokers or those with at least a 10 pack-year smoking history
- Presence of any concurrent diseases that, in the investigator's opinion, would interfere with participation in the study or that might put the participant at risk
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 |
|---|---|---|
| Endoscopic Sinus Surgery | Procedure or surgery | Surgery |
| medical therapySubjects will undergo surgery 6 months after randomization | Other | Medical therapy |
Primary outcome
Asthma Control Score
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Sinus Surgery and medical therapy in people with Asthma and Chronic Sinusitis, run by Endeavor Health 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 12 inclusion and 2 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: stopped early, as of the sponsor's last update on 23 Jul 2019. 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?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
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?
Asthma Control Score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2019.