Assessment of efficacy and safety of Iranian version of NAC and comparing it with foreign sample of NAC in controlling pulmonary symptoms caused by sulfur mustard in chemically-wounded patients and veterans
Objective of trial: Demonstrate efficacy and safety of Iranian version of NAC and comparing it with foreign sample of NAC in controlling pulmonary symptoms caused by sulfur mustard in chemically-wounded patients and veterans and introducing an effective therapeutic alternative for patients suffering from chronic pulmonary injuries caused by sulfur mustard and introducing the better and cheaper substitute anti-oxidant Oslyt instead of Fluimucil in order to decrease clinical and financial problems of patients
Study design: Parallel-Group Non-Inferiority Double-Blind Randomized Clinical Trial
Both Patients and those measuring the outcomes of the study (researchers) were blinded during the trial,i.e., double-blind and the data analysis committee (analysts) was not blinded during the trial
Inclusion Criteria: documented exposure to sulfur mustard; documented diagnosis of chronic pulmonary disease due to mustard gas (histological evidence from previous biopsies)
Exclusion Criteria: any severe side effects of N-acetylcysteine (anaphylactoid reactions); consuming less than 80% of the prescribed NAC
Sample size: 84 individuals
One group will consume a total daily dosage of 1800 mg (3 times a day and each time one effervescent 600 mg tablet) of NAC from the Iranian Osvah pharmaceutical company (Oslyt®, Osvah Pharmaceutical Company, Tehran, Iran) and the other group will consume a total daily dosage of 1800 mg (3 times a day and each time one effervescent 600 mg tablet) of NAC from the foreign Zambon pharmaceutical company (Fluimucil®, Zambon Switzerland Ltd., Cadempino, Switzerland). The duration of the trial will be 4 months and patients will receive a daily dosage of 1800 mg of either oslyt or fluimucil for 4 months.
Primary outcome or outcomes of trial: the difference and changes of severity of dyspnea, wake-up dyspnea, cough and presence or no-existence of sputum and difference and changes of spirometric indices after consuming NAC
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506181165N5
Registration date:2015-07-13, 1394/04/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-13, 1394/04/22
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Baqiyatallah University of Medical Sciences
Osvah Pharmaceutical Company
Expected recruitment start date
2015-07-06, 1394/04/15
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of efficacy and safety of Iranian version of NAC and comparing it with foreign sample of NAC in controlling pulmonary symptoms caused by sulfur mustard in chemically-wounded patients and veterans
Public title
Examining the effect of NAC tablet on improving lung problems caused by mustard gas in chemically-wounded patients and veterans
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: documented exposure to sulfur mustard; documented diagnosis of chronic pulmonary disease due to mustard gas (histological evidence from previous biopsies); no history of tuberculosis; no history of resection of one or more lobes of lung
Exclusion criteria: pneumonia; acute bronchitis; smoking cigarettes; being a substance abuser; any illness in which the medications could not be stopped; occurrence of any severe side effects of N-acetylcysteine (anaphylactoid reaction); use of any kind of antioxidant drugs; deterioration of clinical conditions during the course of the study; consuming less than 80% of allocated NAC medication
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
We used the block randomization technique as the randomization procedure in our trial; if Oslyt group is shown by the letter A and Fluimucil group by B, randomization blocks are quaternary, i.e., AABB, BBAA, BABA, ABBA, ABAB and BAAB. In total, 21 blocks are established and patients are allocated to Oslyt or Fluimucil by these blocks and therefore, randomized.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Sheykh Bahaei-South st., Mollasadra st., Vanak square, Tehran
City
Tehran
Postal code
Approval date
2015-06-17, 1394/03/27
Ethics committee reference number
BMSU.REC.1394.107
Health conditions studied
1
Description of health condition studied
Chronic respiratory disorders caused by chemical weapons (sulfur mustard; mustard gas)
ICD-10 code
J68.4, Y36
ICD-10 code description
due to inhalation of chemicals, gases, fumes and vapours
Primary outcomes
1
Description
Cough
Timepoint
Before intervention, four months after intervention (end of intervention)
Method of measurement
likert scale from 1 to 5: 1=I did not have cough 2=I have cough, but it is not a serious problem 3=I have cough, sometimes disturbs my work 4=I have disturbing cough, usually disturbs my work 5=I have disturbing cough, always disturbs my work
2
Description
Dyspnea
Timepoint
Before intervention, four months after intervention (end of intervention)
Method of measurement
likert scale from 1 to 5: 1=There is no dyspnea 2=Dyspnea only in extraordinary exercises 3=Dyspnea in ordinary exercise 4=Dyspnea in mild exercise 5=Dyspnea in rest
Secondary outcomes
1
Description
Wake-up dyspnea
Timepoint
Before intervention, four months after intervention (end of intervention)
Method of measurement
likert scale from 1 to 4: 1=I never woke up due to dyspnea 2=I wake up less than once a week 3=I wake up once a week 4=I wake up more than twice a week
2
Description
Side effects of Iranian NAC (Oslyt) and Foreign NAC (Fluimucil)
Timepoint
At the end of the second week of the trial
Method of measurement
At the end of the second week of the trial and in a clinical visit, patients in both groups were asked about the side effects of NAC including nausea, vomiting, unpleasant taste of tablet, gastrointestinal distress, diarrhea, constipation and symptoms related to anaphylactoid reactions like urticaria, rash, suffocation feeling, dysphagia, dizziness, reduced blood pressure, pruritus and etc.
3
Description
Sputum
Timepoint
Before intervention, four months after intervention (end of intervention)
Method of measurement
Sputum was reported as 0 for absence and 1 for presence
4
Description
Delta Cough
Timepoint
Four months after intervention (end of intervention)
Method of measurement
Cough Score at month 4 minus cough score at month 0
5
Description
Delta dyspnea
Timepoint
Four months after intervention (end of intervention)
Method of measurement
Dyspnea Score at month 4 minus dyspnea score at month 0
6
Description
Delta Wake-up dyspnea
Timepoint
Four months after intervention (end of intervention)
Method of measurement
Wake-up Dyspnea Score at month 4 minus wake-up dyspnea score at month 0
7
Description
FEV1
Timepoint
Before intervention, two months after intervention, four months after intervention (end of intervention)
Method of measurement
Measured by a HI-801 Chest M.I. Spirometer, Tokyo, Japan and unit of measurement is liter
8
Description
FVC
Timepoint
Before intervention, two months after intervention, four months after intervention (end of intervention)
Method of measurement
Measured by a HI-801 Chest M.I. Spirometer, Tokyo, Japan and unit of measurement is liter
9
Description
FEV1/FVC
Timepoint
Before intervention, two months after intervention, four months after intervention (end of intervention)
Method of measurement
FEV1 divided by FVC that has no specific unit
Intervention groups
1
Description
In the control group, patients consume the standard treatment of Foreign NAC (Fluimucil) with a total daily dosage of 1800 mg (three times a day and each time a 600 mg effervescent oral tablet) for four months
Category
Treatment - Drugs
2
Description
In the intervention group, patients consume the Iranian NAC (Oslyt) with a total daily dosage of 1800 mg (three times a day and each time a 600 mg effervescent oral tablet) for four months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital Sub-specialty Clinic
Full name of responsible person
Dr. Mostafa Ghanei-Physician-Pulmonologist-Full Professor
Street address
Third floor, Baqiyatallah Clinic building, Sheykh bahaei st., Mollasadra st., Vanak square, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Morteza Izadi-Research and technology deputy of Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Sheykh bahaei st., Mollasadra st., Vanak square, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Baqiyatallah University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Osvah Pharmaceutical Company
Full name of responsible person
Dr. Ehsan Sanati-Director of Market Research & Clinical Trials
Street address
17 Shahrivar St., Shad Abad, Karaj Old Road, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Osvah Pharmaceutical Company
Proportion provided by this source
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
Baqiyatallah University of Medical Sciences-Chemical Injuries Research Center
Full name of responsible person
Dr. Yunes Panahi
Position
Head of Chemical Injuries Research Center-PhD in Pharmacotherapy-Associate Professor
Other areas of specialty/work
Street address
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Sheykhbahaei st., Mollasadra st., Vanak square, Tehran
City
Tehran
Postal code
Phone
+98 21 8248 2507
Fax
+98 21 8821 1524
Email
yunespanahi@yahoo.com circevaluations@yahoo.com
Web page address
http://y_panahi.cv.research.ac.ir/Default.aspx
Person responsible for scientific inquiries
Contact
Name of organization / entity
Chemical Injuries Research Center, Baqiyatallah University of Medical sciences, Qazvin University of
Full name of responsible person
Dr. Aboutaleb Simiari
Position
Resident of Internal medicine
Other areas of specialty/work
Street address
Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Sheykhbahaei st., Mollasadra st., Vanak square, Tehran
City
Tehran
Postal code
Phone
+98 21 8248 2507
Fax
+98 21 8821 1524
Email
mghanei@hbi.irm.ghanei@bmsu.ac.ir
Web page address
http://ghanei.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)