Efficacy and safety of QMF149 vs. salmeterol xinafoate/fluticasone propionate in patients with chronic obstructive pulmonary disease (COPD)

Conditions: Chronic obstructive pulmonary disease (COPD)
MedDRA version: 14.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2012-001172-12-GR

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 576

Inclusion Criteria

1. Patients with moderate to very severe COPD (GOLD 2 to GOLD 4)
according to the 2011 GOLD Guidelines
2. Patients with a post-bronchodilator FEV1 < 70% of the predicted
normal, and a post-bronchodilator FEV1/FVC < 0.70 at run-in (Visit
101).
3. Current or ex-smokers who have a smoking history of at least 10 pack
years (defined as the number of packs of 20 cigarettes smoked per day
multiplied by number of years the patient smoked. e.g.10 pack years = 1
pack /day x 10 yrs, or
½ pack/day x 20 yrs). An ex-smoker may be defined as a subject who
has not smoked for = 6 months at screening.
*Other protocol-defined inclusion criteria may apply
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 576
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1. Patients who have had a COPD exacerbation that required treatment
with antibiotics and/or oral corticosteroids and/or hospitalization in the
6 weeks prior to screening (Visit 1).
2. Patients who develop a COPD exacerbation between screening (Visit
1) and treatment (Visit 201) will not be eligible but will be permitted to
be re-screened after a minimum of 6 weeks after the resolution of the
COPD exacerbation.
3. Patients who have had a respiratory tract infection within 4 weeks
prior to screening Visit 1.
4. Patients who develop a respiratory tract infection between screening
(Visit 1) and treatment (Visit 201) will not be eligible, but will be
permitted to be rescreened 4 weeks after the resolution of the
respiratory tract infection.
5. Patients requiring long term oxygen therapy prescribed for >12 hours
per day.
6. Patients with, a) any history of asthma or, b) onset of respiratory
symptoms prior to age 40 years.
*Other protocol-defined exclusion criteria may apply