Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01066416
Recruitment Status : Unknown
Verified February 2010 by NorthShore University HealthSystem Research Institute.
Recruitment status was:  Recruiting
First Posted : February 10, 2010
Last Update Posted : February 10, 2010
Information provided by:
NorthShore University HealthSystem Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Chronic Sinusitis Procedure: Endoscopic Sinus Surgery Other: medical therapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control
Study Start Date : July 2009
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Asthma Control Score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Inclusion criteria: General

    1. 18 years of age or older
    2. Women need one of the following: negative pregnancy test or suitable birth control or post-menopausal status
    3. Informed consent and ability to comply with study procedures
    4. 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:

  1. 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).
  2. 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:

  1. Current smokers or those with at least a 10 pack-year smoking history
  2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01066416

Contact: stacy m raviv, MD 3124209444

United States, Illinois
Evanston Hospital Recruiting
Evanston, Illinois, United States, 60201
Contact: stacy m raviv, MD    847-570-2000   
Contact: Joseph Raviv, MD    847 570 2000      
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute

Responsible Party: Lewis Smith, Associate Vice President for Research, Northwestern University Identifier: NCT01066416     History of Changes
Other Study ID Numbers: 0001
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Chronic Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes