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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

February 9, 2010
February 9, 2010
July 2009
December 2015   (final data collection date for primary outcome measure)
Asthma Control Score [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control
Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Asthma
  • Chronic Sinusitis
  • Procedure: Endoscopic Sinus Surgery
  • Other: medical therapy
    Subjects will undergo surgery 6 months after randomization
  • Placebo Comparator: Medical therapy
    Patients undergo surgery 6 months after randomization
    Intervention: Other: medical therapy
  • Experimental: Surgery
    Patients undergo surgery at time of randomization
    Intervention: Procedure: Endoscopic Sinus Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: stacy m raviv, MD 3124209444 stacyraviv@gmail.com
United States
 
NCT01066416
0001
Yes
Lewis Smith, Associate Vice President for Research, Northwestern University
NorthShore University HealthSystem Research Institute
Not Provided
Not Provided
NorthShore University HealthSystem Research Institute
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP