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A 12-week randomized, single blind and parallel controlled trial, which is aim to compare the effect of airway bacterial colonization after COPD patient inhaled corticosteroids

A 12-week randomized, single blind and parallel controlled trial, which is aim to compare the effect of airway bacterial colonization after COPD patient inhaled corticosteroids

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004708
Enrollment
Unknown
Registered
2014-05-26
Start date
2014-06-01
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

one:Tiotropium 18ug o.d. / Fluticasone 500ug b.i.d
two:Tiotropium 18ug o.d.

Sponsors

Respiratory Department, the Second Affiliated Hospital of Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged at least 40-year-old adult male or female patients, who have signed an informed consent form prior to initiation of any study-related procedure; 2. Diagnosed COPD (According to 2013 GOLD strategy); 3. At least 2 moderate COPD exacerbation or 1 COPD exacerbation required hospitalization or post-bronchodilator FEV1%< 50% in the previous 12 month.

Exclusion criteria

Exclusion criteria: 1. Patients required treatment with systemic corticosteroids in the 3 month prior to Visit 1; 2. Patients required treatment with antibiotics in the 3 month prior to Visit 1; 3. Patients with clinically significant bronchiectasis; 4. Patients with active pulmonary tuberculosis; 5. Patients unable to use a dry powder inhaler device or Metered Dose Inhaler (MDI).

Design outcomes

Primary

MeasureTime frame
The difference between the two treatment groups in 12 week treatment of airway colonization bacteria abundance;

Countries

China

Contacts

Public ContactQiao Zhang ,Qianli Ma

Respiratory Department, the Second Affiliated Hospital of Third Military Medical University, Chongqing

zhangqiaoo@gmail.com+86 13996030312

Outcome results

None listed

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