Clinical Trial: Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomized Placebo-controlled Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Influence of Oral Doxycycline on Wound Healing After Endonasal Endoscopic Sinus Surgery for Chronic Rhinosinusitis With and Without Nasal Polyposis: a Double-blind Randomi
Brief Summary: This is a randomized, double blind, placebo controlled, parallel group, study in patients with chronic rhinosinusitis with or without nasal polyps. The objective is to test the clinical efficacy of long-term low dose oral doxycycline on wound healing quality after endoscopic sinus surgery.
Detailed Summary:
Sponsor: University Hospital, Ghent
Current Primary Outcome:
- Endoscopic evaluation of quality and speed of wound healing [ Time Frame: at 3 months after first drug intake ]
- Recurrence of nasal polyps [ Time Frame: at 3 months after first drug intake ]
- Recurrence of nasal polyps [ Time Frame: at 6 months after first drug intake ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- nasal and exhaled NO [ Time Frame: at 3 months after first drug intake ]
- nasal and exhaled NO [ Time Frame: at 6 months after first drug intake ]
- subjective assessment of the wound healing [ Time Frame: at 3 months after first drug intake ]
- subjective assessment of the wound healing [ Time Frame: at 6 months after first drug intake ]
- chronic rhinosinusitis symptoms by the patients [ Time Frame: at 3 months after first drug intake ]
- chronic rhinosinusitis symptoms by the patients [ Time Frame: at 6 months after first drug intake ]
- Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire [ Time Frame: at 3 months after first drug intake ]
- Questionnaires: SNOT 22, RSOM, SF36 asthma control questionnaire [ Time Frame: at 6 months after first drug intake ]
- inflammatory mediators in nasal fluid as well as in serum [ Time Frame: at 3 months after first drug intake ]
- inflammatory mediators in nasal fluid as well as in serum [ Time Frame: at 6 months after first drug intake ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Ghent
Dates:
Date Received: September 8, 2010
Date Started: November 2010
Date Completion:
Last Updated: April 18, 2017
Last Verified: April 2017