1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
Evaluation of the effects of Colchicin and Simvastatin combination therapy on the improvement of clinical and laboratory signs and
symptoms of the patients with bronchectasis due to sulfur mustard gas inhalation.
Protocol summary
Summary
The aim of this study is evaluation of the effects of Colchicin and Simvastatin combination therapy on the improvement of clinical and laboratory signs and symptoms of the patients with bronchectasis due to sulfur mustard gas inhalation. This is a double blind randomized phase III clinical trial. We will be recruited patients with bronchectasis due to sulfur mustard gas inhalation who will be referred to the pulmonary clinics affiliated with Shiraz University of Medical Sciences, Shiraz, Iran. The main inclusion criteria are exposure to mustard gas during the Iran-Iraq war and suffering from bronchectasis (confirmed with CT scan). The main exclusion criteria are using Statins or Colchicin in the last 3 months of study starting time; patients with
bronchectasis without lung injury due to sulfur mustard gas and smoking. We will enroll 50 patients with mustard gas induced bronchectasis. Participants will randomly be assigned into intervention and placebo groups and will receive Simvastatin (10 mg) and Colchicine (10 mg) per day for 3 months in intervention group and two starch tablets per day for 3 months in placebo group. As the primary outcome of our study, lung function, clinical signs and symptoms of the patients and the levels of IgE, IgM, IgA and IgG will be assessed before and after intervention. Also, we will consider health-related quality of life as secondary outcomes.
General information
Acronym
IRCT registration information
IRCT registration number: IRCT2015060322547N1 Registration date: 2015-10-23, 1394/08/01 Registration timing: retrospective
Last update:
Update count: 0 Registration date
2015-10-23, 1394/08/01 Registrant information
Name Ali Kooshki
Name of organization / entity Shiraz Medical University Country
Iran (Islamic Republic of) Phone
+98 71 3633 1253 Email address
[email protected] Recruitment status
Recruitment complete Funding source
Vice chancellor for research Shiraz University of Medical Sciences
Expected recruitment start date 2015-05-22, 1394/03/01
Expected recruitment end date 2015-09-23, 1394/07/01 Actual recruitment start date
empty
Actual recruitment end date empty
Trial completion date empty
Scientific title
Evaluation of the effects of Colchicin and Simvastatin combination therapy on the improvement of clinical and laboratory signs and symptoms of the patients with bronchectasis due to sulfur mustard gas inhalation.
2 Public title
Effects of Colchicin and Simvastatin combination therapy on the improvement of the patients with bronchectasis due to sulfur mustard gas inhalation.
Purpose Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Exposure to mustard gas during the Iran-Iraq war and have suffered from bronchiectasis (confirmed with CT scan). Exclusion criteria: Using Statins or Colchicin in the last 3 months of study starting time; Patients with bronchectasis without lung injury due to sulfur mustard gas; Exacerbation of symptoms in the past 4 weeks; Connective tissue disease; Sarcoidosis;
Eosinophilic granuloma; Pneumoconiosis; Lymphoma;
Carcinomatous; Smokers.
Age
From 45 years old to 90 years old Gender
Male Phase
3
Groups that have been masked No information
Sample size
Target sample size: 50
Randomization (investigator's opinion) Randomized
Randomization description Blinding (investigator's opinion)
Double blinded Blinding description Placebo
Used Assignment
Parallel
Other design features
Randomization will be done by block randomization in blocks of four in order of enrollment.
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand street, Shiraz University of Medical Sciences City
Shiraz Postal code Approval date
2015-04-19, 1394/01/30
Ethics committee reference number IR.SUMS.REC.1394.15
Health conditions studied
1
Description of health condition studied Other COPD due to sulfate mustard gas ICD-10 code
J44
ICD-10 code description
Other chronic obstructive pulmonary disease
Primary outcomes
1
Description lung function Timepoint
before intervention - 3 month after intervention Method of measurement
spirometry
2
Description
clinical signs and symptoms of the patients Timepoint
before intervention - 3 month after intervention Method of measurement
history and physical examinations
3
Description
levels of IgE, IgM, IgA and IgG Timepoint
before intervention - 3 month after intervention Method of measurement
Immunoelectrophoresis
Secondary outcomes
1
Description
health-related quality of life Timepoint
before and 3 months after intervention Method of measurement
the St George’s Respiratory Questionnaire
Intervention groups
1
Description
Intervention group: Simvastatin (10 mg) and Colchicine (10 mg) per day for 3 months
Category
Treatment - Drugs
3
2
Description
Placebo group: two starch tablets per day for 3 months Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences, Faghihi Hospital, Motahari and Imam Reza Clinic Full name of responsible person
Professor Dr.Ali Emad Street address
Shiraz University of Medical Sciences City
Shiraz
Sponsors / Funding sources
1 Sponsor
Name of organization / entity Shiraz University of Medical Sciences Full name of responsible person
Seyed Basir Hashemi (reseach assistance of shiraz medical university)
Street address
Shiraz University of Medical Sciences City
Shiraz Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences Proportion provided by this source
100
Public or private sector empty
Domestic or foreign origin empty
Category of foreign source of funding empty
Country of origin
Type of organization providing the funding empty
Person responsible for general inquiries
Contact
Name of organization / entity Shiraz University of Medical Sciences Full name of responsible person
Professor Dr.Ali Emad
Position Professor
Other areas of specialty/work Street address
Shiraz University of Medical Sciences City
Shiraz Postal code Phone
+98 917 719 0079 Fax
[email protected] Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity Shiraz University of Medical Sciences Full name of responsible person
Professor Position
Specialty Lung
Other areas of specialty/work Street address
Shiraz University of Medical Sciences City
Shiraz Postal code Phone
+98 917 719 0079 Fax
[email protected] Web page address
Person responsible for updating data
Contact
Name of organization / entity Shiraz University of Medical Sciences Full name of responsible person
Dr.Ali Kooshki Position
Assistant of Specialty Lung Other areas of specialty/work Street address
Shiraz University of Medical Sciences City
Shiraz Postal code Phone
+98 71 3633 1253 Fax
[email protected] Web page address
4
Sharing plan
Deidentified Individual Participant Data Set (IPD) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
