1. Home
  2. Approved trials
  3. » فارسی

The effect of clarithromycin and doxycycline treatment on sinonasal outcome in patients with chronic rhinosinusitis with polyps after functional endoscopic sinus surgery, a clinical trial study

Protocol summary

Study aim
The effect of clarithromycin and doxycycline treatment on sinonasal outcome in patients with chronic rhinosinusitis with polyps after functional endoscopic sinus surgery, a clinical trial study
Design
A double-blind clinical trial study including placebo on 192 patients with chronic rhinosinusitis who have undergone endoscopic functional sinus surgery before the start of the study and randomly divided into three groups of 64 people using sealed envelope software. The execution and production of the randomization sequence will be done by a researcher who is not involved in the clinical stages of the project, so that both the patient and the researcher are blinded.
Settings and conduct
Location: Amir Al Mo'menin Hospital (Rasht, Iran); Patients and researchers are blinded and samples are randomly selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participation, 18 - 65 years, Disease diagnosis based on clinical symptoms and CT scan by an ENT surgeon, Presence of sinus polyps with no clinical response to antibiotic treatments, Lund Mackay score of 20 or above, Normal coagulation tests History of endoscopic nasal surgery. Non-inclusion criteria: History of systemic diseases involving the nose and sinuses, Fungal sinusitis, Allergy to macrolides or tetracyclines, Pregnancy and breastfeeding, History of coagulation disease or the use of anticoagulants, Severe systemic diseases, Mucocele, Surgery complications, Taking medications with drug interactions with the antibiotics using in this study
Intervention groups
Group Doxycycline + placebo (Patients receiving Doxycycline as add-on therapy); Group Clarithromycin + placebo (Patients receiving Clarithromycin as add-on therapy); Group placebo + placebo (Patients receiving CRS standard regimen)
Main outcome variables
Recurrence of disease and Sinonasal outcome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221224056910N1
Registration date: 2023-01-03, 1401/10/13
Registration timing: prospective

Last update: 2023-01-03, 1401/10/13
Update count: 0
Registration date
2023-01-03, 1401/10/13
Registrant information
Name
Enayatalah gholamalian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3234 7870
Email address
ghbasim@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of clarithromycin and doxycycline treatment on sinonasal outcome in patients with chronic rhinosinusitis with polyps after functional endoscopic sinus surgery, a clinical trial study
Public title
The effect of clarithromycin and doxycycline treatment on chronic rhinosinusitis with polyps after functional endoscopic sinus surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study Age 18 - 65 years Disease diagnosis based on clinical symptoms and computerized tomography scan (CT scan) by an Otorhinolaryngology surgeon Presence of sinus polyps with no clinical response to antibiotic treatments Patients with a Lund Mackay score of 20 or above Normal coagulation tests including prothrombin time (PT) , partial thromboplastin time (PTT), international normalized ratio (INR) History of endoscopic nasal surgery before the study
Exclusion criteria:
History of systemic diseases involving the nose and sinuses such as Wegener's disease, sarcoidosis, cicatricial pemphigoid, acquired immunodeficiency syndrome (AIDS) , T-cell lymphoma, primary ciliary dyskinesia, cystic fibrosis, tumors of the nose and sinuses Fungal sinusitis History of allergy to macrolides or tetracyclines Pregnancy and breastfeeding in women History of coagulation disease (such as hemophilia) or the use of anticoagulants such as heparin Severe systemic diseases such as uncontrolled diabetes or severe congestive heart failure Mucocele Surgery complications Taking medications with drug interactions with the antibiotics using in this study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 192
Randomization (investigator's opinion)
Randomized
Randomization description
Patients would be divided into three groups by Block Randomization and using PASS 11.0 software. The execution and production of the randomization sequence will be done by a researcher who is not involved in the clinical stages of the project, and the assistants of the project will register the participants and assign them to different groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to avoid bias and increase validity, the double-blind method will be used in this research: the patients (through placebo) and the researcher (blind to the sample allocation and prescription drugs) have been blinded; the patients have been divided into three groups of 64 by the sealed envelope software and each patient will receive his own three-digit code.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethic Committees of Guilan University of Medical science
Street address
Guilan university of medical science
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2022-08-31, 1401/06/09
Ethics committee reference number
IR.GUMS.REC.1401.301

Health conditions studied

1

Description of health condition studied
Chronic Rhinosinusitis - Nasal Polyps
ICD-10 code
J32-J33
ICD-10 code description
Chronic Sinusitis – Nasal polyp

Primary outcomes

1

Description
Recurrence of disease
Timepoint
First, third, and sixth months follow up
Method of measurement
Based on physical examination and endoscopic findings

2

Description
Sinonasal outcome
Timepoint
First, third, and sixth months follow up
Method of measurement
Based on sino-nasal outcome test 22 score (SNOT-22 score)

Secondary outcomes

1

Description
Endoscopic condition
Timepoint
First, third,and sixth months follow up
Method of measurement
Lund-Kennedy scale

2

Description
Drugs adverse effects
Timepoint
First, third, sixth months follow up
Method of measurement
Clinical history and physical examination

Intervention groups

1

Description
Doxycycline + placebo group: patients receiving Doxycycline as add-on therapy to standard chronic rhinosinusitis (CRS) treatment : After endoscopic functional sinus surgery, 64 patients assigned to this group were treated for at least three weeks with Doxycycline 100 mg capsules and placebo tablets along with the standard chronic rhinosinusitis regimen (nasal irrigation with physiological serum, fluticasone steroid spray two puffs in the morning and night). The failure or success of treatment will be evaluated through clear reduction of signs and symptoms, improvement of quality of life and prevention of progression or recurrence of the disease based on endoscopic findings and by continuous follow-up. All patients refer to Amir al-Momenin Hospital on an outpatient basis at the same and specified time intervals for clinical re-evaluation and sinus endoscopy. In these consultations, which take place one month, three months and six months after surgery, all patients are evaluated with SNOT22 and Lund Kennedy questionnaires, and the patients' information is recorded. In other words, the follow-up period of patients will be 6 months. Also, patients will be checked for drug side effects after starting the treatment. The evaluated side effects of Doxycycline include increased blood pressure, diarrhea, abdominal pain, back pain, hyperpigmentation of the skin, and inflammation and ulceration of the esophagus.
Category
Treatment - Drugs

2

Description
Clarithromycin + placebo group: patients receiving Clarithromycin as add-on therapy to standard chronic rhinosinusitis (CRS) treatment : After endoscopic functional sinus surgery, 64 patients assigned to this group were treated for at least three weeks with Clarithromycin 500 tablets and placebo capsules along with the standard chronic rhinosinusitis regimen (nasal irrigation with physiological serum, fluticasone steroid spray two puffs in the morning and night). The failure or success of treatment will be evaluated through clear reduction of signs and symptoms, improvement of quality of life and prevention of progression or recurrence of the disease based on endoscopic findings and by continuous follow-up. All patients refer to Amir al-Momenin Hospital on an outpatient basis at the same and specified time intervals for clinical re-evaluation and sinus endoscopy. In these consultations, which take place one month, three months and six months after surgery, all patients are evaluated with SNOT22 and Lund Kennedy questionnaires, and the patients' information is recorded. In other words, the follow-up period of patients will be 6 months. Also, patients will be checked for drug side effects after starting the treatment. The evaluated side effects of Clarithromycin include abdominal pain, diarrhea, nausea, vomiting, dyspepsia, anorexia, headache, Dysgeusia, allergic reactions and hearing loss.
Category
Treatment - Drugs

3

Description
Placebo + placebo group: patients receiving standard chronic rhinosinusitis (CRS) treatment : After endoscopic functional sinus surgery, 64 patients assigned to this group were treated for at least three weeks with placebo tablets and placebo capsules along with the standard chronic rhinosinusitis regimen (nasal irrigation with physiological serum, fluticasone steroid spray two puffs in the morning and night). The failure or success of treatment will be evaluated through clear reduction of signs and symptoms, improvement of quality of life and prevention of progression or recurrence of the disease based on endoscopic findings and by continuous follow-up. All patients refer to Amir al-Momenin Hospital on an outpatient basis at the same and specified time intervals for clinical re-evaluation and sinus endoscopy. In these consultations, which take place one month, three months and six months after surgery, all patients are evaluated with SNOT22 and Lund Kennedy questionnaires, and the patients' information is recorded. In other words, the follow-up period of patients will be 6 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al Mo'menin Educational Remedial & Research Center
Full name of responsible person
Dr. Ali Faghih Habibi
Street address
17th Shahrivar St. Dr. Heshmat Sq.
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3323 8307
Email
amiralmomenin@gums.ac.ir
Web page address
https://amir.gums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Naghipour
Street address
Deputy of Research and Technology, in front of 17 Shahrivar Hospital, Namjoo St.
City
Rasht
Province
Guilan
Postal code
4193713191
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Ali Faghih Habibi
Position
Head of Amir Al Mo'menin Hospital, Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
17th Shahrivar St. Dr. Heshmat Sq.
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3323 8308
Email
dr.faghih@gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Ali Faghih Habibi
Position
Head of Amir Al Mo'menin Hospital, Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
17th Shahrivar St. Dr. Heshmat Sq.
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3323 8308
Email
dr.faghih@gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Enayatollah Gholamalian
Position
ENT Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
17th Shahrivar St. Dr. Heshmat Sq.
City
Rasht
Province
Guilan
Postal code
4139637459
Phone
+98 13 3323 8308
Email
ghbasim@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...