Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control
This study is currently recruiting participants.
Verified February 2010 by NorthShore University HealthSystem Research Institute
Sponsor:
NorthShore University HealthSystem Research Institute
Information provided by:
NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01066416
First received: February 9, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma Chronic Sinusitis |
Procedure: Endoscopic Sinus Surgery Other: medical therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control |
Resource links provided by NLM:
Further study details as provided by NorthShore University HealthSystem Research Institute:
Primary Outcome Measures:
- Asthma Control Score [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Medical therapy
Patients undergo surgery 6 months after randomization
|
Other: medical therapy
Subjects will undergo surgery 6 months after randomization
|
|
Experimental: Surgery
Patients undergo surgery at time of randomization
|
Procedure: Endoscopic Sinus Surgery |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Inclusion criteria: General
- 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.
Inclusion criteria: Asthma
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:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066416
Contacts
| Contact: stacy m raviv, MD | 3124209444 | stacyraviv@gmail.com |
Locations
| United States, Illinois | |
| Evanston Hospital | Recruiting |
| Evanston, Illinois, United States, 60201 | |
| Contact: stacy m raviv, MD 847-570-2000 stacyraviv@gmail.com | |
| Contact: Joseph Raviv, MD 847 570 2000 | |
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
More Information
No publications provided
| Responsible Party: | Lewis Smith, Associate Vice President for Research, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT01066416 History of Changes |
| Other Study ID Numbers: | 0001 |
| Study First Received: | February 9, 2010 |
| Last Updated: | February 9, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Asthma Sinusitis Chronic Disease Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Paranasal Sinus Diseases Nose Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013