Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2010 by NorthShore University HealthSystem Research Institute
Sponsor:
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
  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

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014