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Salmeterol / fluticasone propionate for inflammation in COPD

Salmeterol / fluticasone propionate for inflammation in COPD

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNC-11001270
Enrollment
Unknown
Registered
2011-03-25
Start date
2009-09-01
Completion date
Unknown
Last updated
2017-04-18

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

1:salmeterol / fluticasone propionate 50/500ug Bid for 12 weeks

Sponsors

The Second Affiliated Hospital of the Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Outpatients; aged between 40 and 79 years old, male or female; 2. With diagnosis of moderate to severe COPD: After the use of bronchodilator agents, FEV1/FVC=10 years); 4. Have not used the drugs prohibited in this trial within 30 days of enrollment (with stable dosage); 5. Patients that can properly use the diskus and medication; 6. Sign the informed consent forms.

Exclusion criteria

Exclusion criteria: 1. With other severe diseases that might cause potential risks in patients participating in the trial, influence the outcomes of the trial or affect the ability of patients to take part in the trial; 2. Comorbidity with other diseases of respiratory system (ie. asthma); 3. Patients that need regular or long-term oxygen therapy (>12 hours per day); 4. Patients treated with inhalation or systemic glucocorticoids or/and long-term beta 2 agonists and/or anti-cholinergic drugs; 5. Episodes of moderate to severe AECOPD within 30 days of enrollment (exacerbation of COPD and with the need of systemic glucocorticoids and/or antibiotics therapy or hospitalization); 6. Episodes of respiratory tract infection that need antibiotics therapy within 14 days of enrollment; 7. Use of certain inhibitors (ie. beta receptor blocker); 8. Pregnant or breast-feeding females (* women of reproductive age should adopt contraceptive methods).

Design outcomes

Primary

MeasureTime frame
Percentage of CD4+CD25+ FoxP3+ regulatory T cells in CD4+ T cell;

Secondary

MeasureTime frame
IL-8, TNF-alpha, IL-10 AND 1L-17A in induced sputum;Serum IL-8, TNF-alpha, IL-10 AND 1L-17A;Cells counts in induced sputum;

Countries

China

Contacts

Public ContactGuansong WANG
wanggs2003@gmail.com+86 13883193995

Outcome results

None listed

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