This study is designed to demonstrate non inferiority of 150 *g o.d. of indacaterol versus tiotropium 18 *g o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment.
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate superiority of 150 µg o.d. of indacaterol versus tiotropium 18
µg o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of
treatment Trough is defined as the mean of FEV1 measurements at 23h 10 min and
23h 45 min post morning dose
Secondary outcome
Key
* To demonstrate that indacaterol 150 µg o.d. is non inferior to tiotropium 18
µg o.d. with regard to the rate of exacerbations during 52 weeks of treatment
(see Section 7.4.2 for definition of exacerbation)
See other on page 11
Background summary
Frequent COPD exacerbations are associated with impaired health-related quality
of life and a more rapid decline in lung function. (Wedzicha et al., 2003).
Treatment of COPD exacerbation accounts for a great burden on the health care
system. Therefore effective management of COPD includes treatment and
prevention of COPD exacerbations (Gold guidelines, 2007).
Study objective
This study is designed to demonstrate non inferiority of 150 *g o.d. of
indacaterol versus tiotropium 18 *g o.d. with respect to 24 hour post dose
(trough) FEV1 after 12 weeks of treatment.
Study design
This study is a multicenter, blinded, double dummy, parallel-group design using
tiotropium as an active control. At visit 1, 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.
Intervention
Patients will be assigned to one of the following 2 treatment arms
1) indacaterol 150mcg + placebo tiotropium
2) tiotropium 18mcg + placebo indacaterol
At visit 1 all patients will be provided with salbutamol which they will be
instructed to use throughout the study as rescue medication.
A designated (unblinded) person will be responsible for the Drug accountability
of the patietn and to deliver the medication to the patient when the patient is
in the hospital. This person is not involved in any other protocol related
handlings.
See page 90 protocol.
Study burden and risks
Burden:
A serum pregnancy test will be done 2x (when applicable), 2x a physical exam,
at 8 visits ECGs will be made (in total 28x), at 3 visits urine is tested, at
5 visits blood samples are taken (in total 100ml), at 14 visits long function
tests are done including 2x a reversibility test. Furthermore, the patient will
be asked to complete an electronic diary twice daily.
Risks:
Possible side effects of the study medicine indacaterol (QAB149) can include:
tremor, headache, cough, post-inhalation cough, palpitations, muscle cramps,
nausea, chest pain, trouble sleeping, nervousness, dry mouth, dizziness,
tiredness, feeling generally unwell and possible changes in blood pressue or
potassium or blood sugar.
Side effects of the other study medicine, tiotropium (Spiriva®), include: dry
mouth, constipation, tremor, headache, palpitations, blurred vision, glaucoma,
urinary difficulty, urinary retention, muscle cramps and nausea.
Unexpected problems or side effects that are not known could also occur.
Taking blood and measuring blood pressure could be unpleasant. The risks of
taking blood may include fainting, pain and/or bruising. Rarely, these may be a
small blood clot or infection at the site of the needle puncture. In rare
instances where a nurse, a doctor, or laboratory technician, sustains an
exposure to a patients blood, it may be necessary to test the blood for
Hepatitis-B, Hepatitis-C and HIV.
Raapopseweg 1
6824 DP Arnhem
NL
Raapopseweg 1
6824 DP Arnhem
NL
Listed location countries
Age
Inclusion criteria
1) male and female adults diagnosed with COPD aged 40 years and over
2) co-operative outpatients with a diagnoses of COPD (severe as calissified by the GOLD guidelines 2007 and including;
a) Smoking history of at least 10 pack years, both current and ex-smokers are eligible
b) Post bronchodilator FEV1<50% and >/ 30% of the predicted normal value
3) Post bronchodilator FEV1/FVC <70%
d) A documented history of at least 1 moderated or severe exacerbation in the previous 12 months (pg 14)
Exclusion criteria
for a complete list please see protocol section 5.2
#. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment and/or antibiotics in the 6 weeks prior to screening (Visit 2).
#. Patients requiring oxygen therapy for chronic hypoxemia.
#. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2.
#. Patients with a history (up to and including Visit 2) of asthma indicated by (but not limited to):
a) onset of respiratory symptoms suggestive of asthma prior to age 40 years
b) history of a diagnosis of asthma
#. Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1c > 8.0 % of total hemoglobin measured at Visit 2.
#. Patients with a history (or family history) of long QT syndrome or whose QTc interval (Fridericia) measured at Visit 2 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 | EUCTR2008-007944-33-NL |
| CCMO | NL28149.060.09 |