Early intervention with Carbocysteine and low dose Theophylline in Chinese patients with chronic obstructive pulmonary disease

Multicenter clinical study screening for the effective drugs of early-stage COPD

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800016712

Enrollment

Unknown

Registered

2018-06-19

Start date

2018-06-25

Completion date

Unknown

Last updated

2018-06-25

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

Conditions

chronic obstructive pulmonary disease

Interventions

Carbocysteine group:Carbomethylstan tablets 500 mg, 3 times daily

Theophylline group:Theophylline sustained release tablets 100 mg, 2 times daily

Carbocysteine-placebo group:Carbocysteine-placebo tablets 500 mg, 3 times daily I

Theophylline-placebo group:Theophylline sustained release-placebo tablets 100 mg, 2 times daily

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Community or clinic COPD patients, age between 40 and 80 years, male or female 2. FEV1/FVC <70% after inhaled bronchodilator, FEV1 = 50% predicted (Gold stage I-II) 3. No acute exacerbation of COPD in the last 4 weeks 4. There is the ability to communicate in languages or words 5. Voluntarily participate in the study and sign the informed consent

Exclusion criteria

Exclusion criteria: 1. Severe cardiovascular and cerebrovascular diseases, severe systemic diseases, and malignant tumors; 2. Other diseases causing airflow limitation such as bronchial asthma, bronchiectasis, active tuberculosis, etc. 3. Interstitial lung diseases including pneumoconiosis, alveolar proteinosis, idiopathic pulmonary fibrosis. 4. Myocardial infarction, various arrhythmias, uncontrollable hypertension and diabetes; 5. Active peptic ulcer ; 6. Acute exacerbation of COPD during the screening period; 7. Abnormal laboratory tests, including blood and urine routine, liver and kidney function, Fasting blood glucose, etc. 8. Pregnancy or lactation women; 9. Allergy to study drugs and ß2 receptor agonists; 10.Patients are participating in other drug trials; 11.Long-term use of theophylline or expectorant or steroid drugs; 12.Poor compliance, chronic alcoholism or drug abuse

Design outcomes

Primary

Measure	Time frame
Trough FEV1 and peak FEV1 at 12 months of treatment from baseline;The number of COPD exacerbations at 12 months of treatment;	—

Secondary

Measure	Time frame
Symptom score; Time to first acute exacerbation of COPD;Severity, interval and duration of acute exacerbations of COPD;drop-out rate;Administration of rescue medication;Cost-effectiveness analysis;	—

Countries

China

Contacts

Public ContactWang Qiuyue

The First Hospital of China Medical University

qywngcmu@163.com+86 13998892756

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026