The study is designed to compare the 24-h spirometry profile of two doses of indacaterol (150o.d. and 300 *g o.d.) with that of placebo (o.d.) and with tiotropium (18 *g o.d.) as an activecontrol in patients with COPD.
ID
Source
Brief title
Condition
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine if indacaterol (150 *g o.d. and/or 300 *g o.d.) is superior to
placebo in terms of
24 h post dose trough FEV1 after 14 days of treatment in each treatment period
in patients
with COPD.
Secondary outcome
To determine if indacaterol (150*g o.d. and/or 300*g o.d.) are at least
non-inferior to
tiotropium 18*g o.d. in terms of 24 h post dose trough FEV1 after 14 days of
treatment in
each treatment period in patients with COPD.
To evaluate the effects of indacaterol (150 o.d. and 300 *g o.d.) and
tiotropium (18 *g o.d.) in
terms of peak effect and time to peak effect level as determined by FEV1 on Day
1 of
treatment in each treatment period.
To evaluate the area under the FEV1 time curves (0-24 h) on Day 1 and Day 14 in
each
treatment period
To evaluate the effects of indacaterol and tiotropium in terms of 24 h
post-dose trough FEV1
after 1 day of treatment in each treatment period.
Treatment comparison will be made for FEV1 at each scheduled time point in each
treatment
period.
To evaluate the safety of indacaterol in terms of vital signs, glucose and
potassium, ECG and
adverse events.
Background summary
Indacaterol is a novel long acting B2 adrenerg receptor agonist, meant for once
daily treatment in patients with COPD.
Study objective
The study is designed to compare the 24-h spirometry profile of two doses of
indacaterol (150
o.d. and 300 *g o.d.) with that of placebo (o.d.) and with tiotropium (18 *g
o.d.) as an active
control in patients with COPD.
Study design
A phase III, randomized, double-blind, double-dummy, placebo-controlled,
multicenter, 3-period incomplete block, multidose crossover study to determine
the effect on lung function of indacaterol (150 and 300 mcg o.d.) in patients
with moderate to severe COPD, using tiotropium (18 mcg o.d.) as an active
control
During the pre screen visit (vo) the informed consent is obtained and current
COPD medications are reviewed and if necessary arrangements are made to adjust
prohibited COPD therapy to allowable COPD therapy.
At the screening visits (v1 and 2) eligibility is being assessed to protocol
criteria. The period betrween v1/v2 and V3 (14 days) is called the run in
(screeningperiod) and is used to assess further eligibility for the study and
to collect baslin diary data.
At the baseline visit (v3) patients whose eligibility is confirmed will be
randomized to one of the available treatment sequences in this 3 period cross
over design. Patient will then enter the first of the 3 double blind 14 days
treatment period. Patients will be assessed on consecutive days at the
beginning and end of each treatment period (the first and second and the 14th
and 15th day). On the first and 14the day the patietns will be required to
remain at the study center until 14 hours after taking study medication.
Patients will then return on the next day to complete the 23h10,23h45 and 23u55
post dose spirometry.
In total the patients will be required to visit the study centre 14 times (excl
V0). In between the treatment period there is a wash out period of also 14
days.
During the study patients will be permitted to use allowable COPD mediation
described in section 5.1 of the protocol and will be provided with a salbutamol
inhaler to use as rescuemedication.
Intervention
Indacaterol 150mcg
Indacaterol 300mcg
Tiotropium 18mcg
Placebo
salbutamol as rescuemedication
Study burden and risks
It cannot be guaranteed that the health of each individual patient will improve
by participating in this study. Patients will be checked up regularly during
this study and medication will be provided at no costs.
The results of this study might help other patients with COPD.
Burden;
2 questionnaires to be completed at V3, 2 times Physical examination, once
reversibility testing, on 14 visits spirometry, at 13 visits blood sampling and
on 8 visits multiple ECGs will be made
In addition to the standard blood draws, there will be PK blood draws. In total
(standard plus PK), 314 ml blood will be drawn.
Possible side effects of indacaterol can include: tremor, headache, coubh,
palpitations, muscle cramps, nausia, chest pain, trouble sleeping, nervousness,
dry mouth, dizziness, tiredness, felling generallty unwell and possible changes
in blood pressure or potassium or blood sugar.
Raapopseweg 1
6824 DP
Nederland
Raapopseweg 1
6824 DP
Nederland
Listed location countries
Age
Inclusion criteria
* Male or female patients aged 40 years and older
* Patients with moderate to severe stable COPD according to the COLD Guidelines 2006
* Patients with a smoking history of at least 10 pack years
* Patients with a post-brochodilator FEV1 equal or greater than 30% of the predicted normal value and less than 80% of the predicted normal value, and post bronchodilator FEV1/FVC less than 0.7
Exclusion criteria
* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
* Patients requiring long term oxygen therapy
* Patients who have had a respiratory tact infection within 6 weeks prior to V1
* Patients with a history of Asthma
* Patients with diabetes Type 1 and uncontrolled diabetes type II
* Patients with a hostory of long QT syndrome or whose QTc interval measured at visti 1 or 3 is prolonged
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-004071-19-NL |
| CCMO | NL20571.060.07 |