The Efficacy and Safety of Salmeterol/Fluticasone Propionate vs Atropium/Albuterol in Patients COPD

Fudan University

Status and phase

Unknown

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Salmeterol/Fluticasone Propionate

Study type

Interventional

Funder types

Other

Identifiers

NCT01243788

SCO113162 (Other Grant/Funding Number)

Details and patient eligibility

About

To determine the efficacy and safety of Salmeterol/Fluticasone Propionate 50/500ug BID vs Ipratropium/Albuterol 36/206ug QID in Chinese patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD).

Full description

This is a 12-week, multicentre,randomized,open-label,active-controlled, paralleled-group study.
Chinese patients aged ≥40 years with moderate-to-severe COPD are eligible for this study.
1. If satisfying the entry criteria, patients enter an 8 to 14 day run-in period,and replace previous bronchodilators with inhaled or nebulized Salbutamol.
2. Patients record daily severity ratings for daytime symptoms of shortness of breath, tiredness, activity limitation, frustration with symptoms, and night-time sleep symptoms on daily cards.
3. Each symptom is rated using 0-100 visual analog scal (VAS). For overall assessment of daytime symptoms, a combined symptom score is obtained by adding VAS scores for shortness of breath, tiredness, activity limitation, frustration with symptoms.
4. Patients are required to be symptomatic as demonstrated by a combined daytime symptom score of 120 on at least 4 of the 7 days prior to randomization.

1. Eligible patients will be randomized (1:1) to the following 2 treatments for 12 weeks.
  1. Inhaled Salmeterol/Fluticasone propionate 50/500ug twice daily or inhaled IB/ALB 36/206ug QID.
  2. Salbutamol will be provided for relief of symptoms on an "as required" basis during the whole 12 weeks.
2. A Follow-up visit will be conducted 2 weeks after completion of treatment/early withdrawal to assess for any adverse effects after discontinuing study treatment.

Enrollment

450 estimated patients

Sex

All

Ages

40 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chinese male or female outpatients aged 40 to 79 years, inclusive
Patients with an established diagnosis of COPD, defined as GOLD guideline postbronchodilation FEV1/FVC ratio of <70%, AND Postbronchodilation FEV1% predicted ranged from ≥25 to ≤70.
A cigarette smoking history of 10 pack-years
Use of oral theophylline, or any other inhaled medications other than LABA, LAMA, or ICS for≥30 days (e.g. SABA, SAMA)
Patients who are able to use Accuhaler device and relief medication
Patients willing to give informed consent to participate in the study and comply to study protocol
Eligible female on child-bearing potentia

Exclusion criteria

Patients with concurrent respiratory disorders (e.g. asthma) other than COPD
Patients with a requirement for regular or long term oxygen therapy (>12h/d)
Patients who used inhaled or oral steroids within 30 days of screening
Patients who had a respiratory tract infection requiring antibiotics within 14 days of screening
Patients with a moderate-to-severe COPD exacerbation within 30 days of screening
Patients with any significant medical condition or disease that would place patients at risk or interfere with the study evaluation.
Patients who used some inhibitory agents (e.g. b blockers) within 14 days of screening
Female patients who is pregnant or may be pregnant in the study duration