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Phase III, Randomaized, Double blind study of low dose long term Azithromycin versus placebo in treatment of chronic pulmonary lesions due to sulfur mustard

Phase III, Randomaized, Double blind study of low dose long term Azithromycin versus placebo in treatment of chronic pulmonary lesions due to sulfur mustard

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT138706111165N1
Enrollment
141
Registered
2008-10-02
Start date
2004-04-20
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sulfur mustard injured patients.

Interventions

Azithromycin 250 mg daily.
Azithromycin 250 mg daily

Sponsors

Janbazan Medical and Engineering Research Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Documented exposure to single high dose of sulfur mustard (SM) gas. 2- Documented chronic pulmonary disease caused by SM by HRCT. 3- Patients' will to enter the study. Exclusion criteria: 1-having pneumonia and/or acute bronchitis; 2-smoking cigarettes or being a substance abuser; 3-having any illnesses in which the medications could not be stopped; 4-occurrence of any severe side effects of macrolides (headache, GI upset, fever, skin rash, abdominal dicomfort, diarrhea, gray feces, icter, eosinophilia, stridor, acute cholestatic hepatitis, pruritus, dark urine, osteomatitis, depression, fatigue, dysphagia, glossitis, dizziness, bahavioral changes); 5-using any kind of antioxidant drugs; 6-deterioration of clinical conditions during the course of the study. 7- Simultanous use of following drugs: Terfenadine, teophyline or its analogues, carbamazepin, ergotamin, anticoagulants like warfarin, cisapride, digoxin, triazolam, phenytoin, corticosteroids (prednisolone over 10mg/day), immunosupressives, systemic antibiotics. 8- illiterate patient, 9-exacerbation of disease in the last month, 10-abnormal serum creatinine, ALT, AST, total bilirubin > 2x normal 11-not using at least 80% of the drugs in the course of the trial.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Cough. Timepoint: 3 months and 6 months from begining of the trial and 3 months follow up. Method of measurement: History.;Dyspnea. Timepoint: 3 months and 6 months from begining of the trial and 3 months follow up. Method of measurement: History.;Sputum. Timepoint: 3 months and 6 months from begining of the trial and 3 months follow up. Method of measurement: History.;Hemoptysis. Timepoint: 3 months and 6 months from begining of the trial and 3 months follow up. Method of measurement: History.;Lung Function (FEV1, FVC, FEV1/FVC). Timepoint: 3 months and 6 months from begining of the trial and 3 months follow up. Method of measurement: Spirometry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Yunes Panahi

chemical iinjuries research center, Baqiyatallah university of medical sciences

yunespanahi@bmsu.ac.ir+98 21 8860 0067

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026