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

A Pilot Study To Evaluate The Effect Of N-Acetyl Cysteine (NAC) On The Bronchodilator Response With Inhaled Salbutamol And Ipratropium In Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/11/002138

Enrollment

Registered

2011-11-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Chronic Obstructive Pulmonary Disease

Interventions

Intervention1: Tablet N acetyl cysteine, (Ipratropium, Salbutamol): 600mg BD for 14 days, (80mcg, 400mcg respectively during study visit to observe reversibility) Control Intervention1: No treatment,

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
? 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 ? Change in the cell counts from the baseline between NAC and no-NAC treatment arms, and its association with change in bronchodilatory response. Timepoint: Gap of 5 minutes after every test.	—

Secondary

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactMr Moinodin Shaikh

Chest Research Foundation

bbrashier@crfindia.com9823834593

Outcome results

None listed

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