None listed
Conditions
Interventions
Group 1 Type of group
Indacaterol Twisthaler® 62.5 ug o.d. for 14 days
Group name:Group 6 Type of group
Placebo of indacaterol Twisthaler®, o.d. and placebo of formoterol Aerolizer®, b.i.d. for 14 days
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Male adults and women> 40 years of age who have signed the informed consent form before the start of any procedure related to the study (which includes any adjustment of their current treatment for COPD - see Section 6.6.5.5.) • Cooperative outpatients diagnosed with COPD (moderate to severe according to the classification of the GOLD guidelines, 2006) and:  Smoking history of at least 10 packets-year  Post-bronchodilator VEF1 30% of the predictive normal value.  VEF1 / CVF Post-bronchodilator <70%
Exclusion criteria
Exclusion criteria: • Pregnant women, breastfeeding mothers or women with reproductive potential, regardless of whether they are sexually active or not, if they are not going to use acceptable methods of contraception. • Patients who have been hospitalized for an exacerbation of their airway disease within 6 weeks prior to visit 1 or between visit 1 and 2. • Patients with a history of asthma. • Patients with acute respiratory tract infection within 4 weeks prior to visit 1, will not be able to enter the study. • Other clinically significant conditions that may interfere with the conduct of the study or with patient safety, as specified in the protocol. (For a complete listing of the exclusion criteria refer to Section 5.1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:hange in basal FEV1 valley 24 hours post-dose Measure:Mean change in basal FEV1 valley 24 hours post-dose after 14 days of treatment Timepoints:14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:change in VEF1 basal valley 24 hours post-dose Measure:Mean change in VEF1 basal valley 24 hours post-dose after 1 day of treatment Timepoints:24 hours ; Outcome name:FEV1, FVC at times: -50 min., -15 min., 5 min, 30 min., 1, 2, 3, 4 h, post-dose on day 1 (Visit 2) and at 23 h 10 min. and 23 h 45 min. on day 2 (Visit 3) Measure:FEV1, FVC at times: -50 min., -15 min., 5 min, 30 min., 1, 2, 3, 4 h, post-dose on day 1 (Visit 2) and at 23 h 10 min. and 23 h 45 min. on day 2 (Visit 3) Timepoints:2 days ; Outcome name:FEV1, FVC at the moments: -50 min., -15 min., 5 min., 30 min., 1,2, 3,4 h, on day 14 (Visit 4) and at 23 h 10 min. and 23 h 45 min. on Day 15 (Visit 5) Measure:FEV1, FVC at the moments: -50 min., -15 min., 5 min., 30 min., 1,2, 3,4 h, on day 14 (Visit 4) and at 23 h 10 min. and 23 h 45 min. on Day 15 (Visit 5) Timepoints:15 days ; Outcome name:Inspiratory capacity, use of rescue medication, morning measurements and nights of PEF. Measure:Inspiratory capacity, use of rescue medication, morning measurements and nights of PEF. Timepoints:15 days | — |
Countries
France, Germany, Hungary, Ireland, Italy, Latovia, Lithuania, United Kindgdom
Contacts
Public ContactCarmen Maria La Rosa
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed