Placebo-controlled study on efficacy and safety of N-acetylysteine high dose in exacerbation of chronic obstructive plumonary disease

Conditions

Chronic Obstructive Pulmonary Disease

Papi A, Zheng J, Criner GJ, Fabbri LM, Calverley PMA.

2019-01-0921 citations

10.1016/j.rmed.2018.12.014

Twice daily N-acetylcysteine 600 mg for exacerbations of chronic obstructive pulmonary disease (PANTHEON): a randomised, double-blind placebo-controlled trial.

Zheng JP, Wen FQ, Bai CX, Wan HY, Kang J, Chen P, Yao WZ, Ma LJ, Li X, Raiteri L, Sardina M, Gao Y, Wang BS, Zhong NS, PANTHEON study group.

2014-01-30187 citations

10.1016/s2213-2600(13)70286-8

TWICE DAILY N-ACETYLCYSTEINE 600 MG FOR EXACERBATIONS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (PANTHEON): A RANDOMISED, DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL

Jinping Zheng, Fu-Qiang Wen, Chunxue Bai, Wan Huan-ying, Jian Kang et al. (14 authors)

PULMONOLOGIYA2014-01-0131 citations

10.18093/0869-0189-2014-0-3-86-98

Interventions

A:NAC 600mg Oral Bid

B:Placebo Oral Bid

Eligibility

Sex/Gender

All

Age

40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients able to provide written informed consent and to fulfil study requests; 2. Outpatients, smoking or non-smoking, male or female; 3. Patients with a clinical diagnosis of COPD, post-bronchodilator FEV1/FVC <70%, and post-bronchodilator FEV1 between 30% and 70% of predicted; (1) Moderate COPD (GOLD stage II): 50<=FEV1<70% predicted; (2) Severe COPD (GOLD stage III): 30<=FEV1<50% predicted; 4. Patients with a history of at least two exacerbations within the previous two years and who are clinically stable for at least 4 weeks.

Exclusion criteria

Exclusion criteria: 1. Patients with a diagnosis of bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, pneumonia, bronchial pneumonia, bronchiectasis, lung cancer or lung metastases, other progressively fatal disease; 2. Patients with severe cardiovascular diseases, severe neurological diseases or severely impaired hepatic or renal function; 3. Patients requiring mechanical airway management or long-term oxygen therapy (12 h or more per day) or need of pulmonary rehabilitation; 4. Patients on treatment with systemic corticosteroids at inclusion; 5. Hospitalized patients and patients from institutional care facilities; 6. Immuno-compromised patients; 7. Patients with suspected or known hypersensitivity to the study product or to any of its excipients (such as for sucrose: patients with rare hereditary problems of fructose intolerance(glucose-galactose malabsorption or sucrase-isomaltase insufficiency); 8. Patients known to have conditions affecting study drug absorption or history of peptic ulcer; 9. Pregnant or lactating women or women of childbearing age not using a medically acceptable method of contraception or in post-menopause for at least one year; 10. Patients presenting poor reliability (e.g. history of alcohol or drug abuse, bad mental conditions) and poor compliance; 11. Patients already enrolled in this study or patients who have received any other investigational drug within 3 months prior to study entry.

Design outcomes

Primary

Measure	Time frame
Yearly acute exacerbation rate (times/person/year;	—

Secondary

Measure	Time frame
Difference in using short acting beta 2 agonist or others;Change from baseline patient’s Quality of Life;Number and frequency of patients with exacerbation;Time from the first exacerbation to recurrent exacerbation;Decline from baseline for the Forced Expiratory Volume 1;	—

Countries

China

Contacts

Public ContactNanshan Zhong

xiaqikui@zambon.com.cn+86 020 83337750-6062

Outcome results

None listed