A clinical trial to study the effect of N-acetyl cysteine in patients with Chronic Obstructive Pulmonary Disease.

Phase 4

Conditions: Health Condition 1: null- Chronic Obstructive Pulmonary Disease

Registration Number: CTRI/2011/11/002138

Lead Sponsor: Cipla Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Adult males or females with a diagnosis of Chronic Obstructive Pulmonary Disease

COPD defined as FEV1/FVC < 0.7 and FEV1 < 80% predicted

Exclusion Criteria

•Previous history of diagnosis of asthma

•Previous history of atopy except controlled allergic rhinitis

•History of concomitant pulmonary disease

•Patients with bronchogenic carcinoma

•Patients having known hypersensitivity to NAC

•Patients with peripheral eosinophill count more than 600/Âµl of blood.

•Patients already on NAC therapy or any mucolytic agent

•Patients having history suggestive of high antioxidant intake through nutritional route

•COPD with exacerbation within the previous three months requiring oral steroids, nebulised bronchodilator, antibiotics or an emergency visit to the doctor

•Patients having uncontrolled allergic rhinitis

•In the opinion of the investigator the patient would not be able to comply with the study procedures

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
? Change in bronchodilatory response from the baseline with NAC and no NAC treatment arms in context to FEV1, R 5 Hz, R 20 Hz, R 5 Hz - R 20 Hz, X 5 Hz, RV, IC, RV/TLC, sGaw tot, sGaw eff <br/ ><br>? Change in the cell counts from the baseline between NAC and no-NAC treatment arms, and its association with change in bronchodilatory response. <br/ ><br>Timepoint: Gap of 5 minutes after every test. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Change in the cell counts from the baseline between NAC and no-NAC treatment arms, and its association with change in bronchodilatory response.Timepoint: After all tests have finished