A randomized, multi-center, double-blind, double-dummy, parallel-group, 8 week pilot study, to investigate the effect of QMF Twisthaler® (250/400 µg q.d. evening) compared to fluticasone propionate/salmeterol (250/50 µg b.i.d.) FSC in patients with Chronic Obstructive Pulmonary Disease (COPD).

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

•Male and female adult patients aged > 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure, including any adjustments to COPD medication prior to Visit 1.
•Patients with a diagnosis of moderate to severe COPD as classified by the GOLD guidelines (2006) and who additionally meet the following criteria:
a) Ex-smoker or current smoker with a smoking history of at least 10 pack years.
NOTE: Current smokers must provide verbal notification or written documentation that attests to their inability to stop smoking after participation (or declining to participate) in a smoking cessation program. Ex-smokers are defined as those who have stopped smoking at least 12 months prior to Visit 1.
b) Post-bronchodilator FEV1 at Visit 1 between 30 and 65% of the predicted normal value [Quanjer et al. 1994]. This criterion for FEV1 will have to be demonstrated after a washout period of at least 6 hr during which no short acting ?2-agonist has been inhaled, 8 hr for short acting anti-cholinergic, or FDC of inhaled anticholinergic/SABA, and 48 hr for ICS, long-acting ß2-agonists or FDC of ICS/ß2 agonist
c) Post-bronchodilator FEV1/FVC < 70%
d) TLC or FRC of 120% of the predicted normal value for those patients undergoing the body plethysmography assessments.
(Post-bronchodilator refers to measurements approximately 30 minutes after inhalation of 4 inhalations of 100/90 µg of salbutamol/albuterol MDI or equivalent dose of DPI)
•Patients must be on only short acting ß2 agonist for relief for at least 7 days prior to randomization (Visit 2)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception.
•Patients with COPD exacerbation within 4 weeks prior to randomization which requires medical intervention or treatment with additional excluded medication.
•Patients demonstrating an increase in FEV1 = 400 mL 30 minutes after administration of four inhalations of 100/90 µg salbutamol/albuterol at the screening visit.
•Patients requiring oxygen therapy (>15 hr a day) for chronic hypoxemia (`prn’ use up to 10 hr total in any given 24 hr period is acceptable).
•Patient with an acute respiratory tract infection within 4 weeks prior to Visit 1. Patients who develop a respiratory tract infection between Visit 1 and visit 2 must discontinue from the trial, but may be permitted to re-screen at a later date (at least 4 weeks after the resolution of the respiratory tract infection).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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