Primary: To demonstrate the superiority of NVA237 50 *g o.d. compared to placebo in addition to background therapy with long acting B2 agonist/ inhaled corticosteroid (* 800 *g/day of budesonide or equivalent) in terms of trough FEV1 after 26 weeks…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Through level FEV1 after 26 weeks of treatment.
Secondary outcome
Time to 1st moderate to severe asthma exacerbation *definition see protocol
page 50), ACQ-7 at week 26. At week 52: St George questionnaire, asthma quality
of life questionnaire, ACQ-7, 6, 5, trough FEV1 and other pulmonary function
parameters.
Throughout the study: pulmonary function parameters, peakflow at home, asthma
symptoms, rescue medication use, safety and tolerability.
Background summary
NVA237 is an anti-cholinergic drug, that is being developed as an inhalation
powder for the treatment of bronchial asthma for a once daily dosing. The drug
has proven safe and effective so far. It has been registered for the indication
COPD.
The current phase III study is part of the Development program for asthma.
Study objective
Primary: To demonstrate the superiority of NVA237 50 *g o.d. compared to
placebo in addition to background therapy with long acting B2 agonist/ inhaled
corticosteroid (* 800 *g/day of budesonide or equivalent) in terms of trough
FEV1 after 26 weeks of treatment.
Secondary: To demonstrate superiority of NVA237 50 *g od compared to placebo in
addition to background therapy with long acting B2 agonist/ inhaled
corticosteroid (* 800 *g/day of budesonide or equivalent) for time to 1st
moderate to severe asthma exacerbation and ACQ-7 at week 26.
To compare the efficacy of NVA237 50 mcg od compared to placebo in terms of
health outcome questionnaires, pulmonary function parameters, peak flow, asthma
symptoms, rescue medication, safety and tolerability.
Study design
Multicenter gerandomiseerd dubbelblind fase III onderzoek met parallelle
groepen. Washout of prohibited medication. Run-in period on LABA/ ICS (* 800 *g/
day of budesonide or equivalent) Thereafter randomization (1:1) to treatment
with:
3. NVA237 50 mcg od
4. Placebo
during 52 weeks in a single dose dry powder inhaler.
Background medication long acting B2 agonist/ inhaled corticosteroid (* 800 *g/
day of budesonide or equivalent).
Salbutamol rescue medication.
Treatment duration 56 weeks.
Approx1938 patients.
Intervention
Treatment with NVA237 or placebo.
Study burden and risks
Risk: Adverse effects of study medication. Discontinuation of prohibited
medication.
Burden: 10 visits (4 with an additional blood draw the next morning) plus 1
final telephone call. Duration 1-4 hours.
Physical examination 5 x.
Safety blood tests 4 x (8 ml); fasting.
Pregnancy test 3 x.
Pulmonary function test plus reversibility 1 x.
Serial pulmonary function tests during all visits of treatment period; 4 visits
9 tests (incl. trough values next morning); 4 visits 2 tests.
ECG 5 x.
Questionnaires (St George questionnaire, asthma symptom questionnaire, asthma
quality of life questionnaire) 4 x.
Diary (asthma symptoms, rescue medication) and peak flow twice daily during
run-in and treatment period.
Optional: pharmacogenetic research; 1 blood sample of 10 ml.
Raapopseweg 1
Arnhem 6824 DP
NL
Raapopseweg 1
Arnhem 6824 DP
NL
Listed location countries
Age
Inclusion criteria
* Male and female adult patients aged 18-75 years.
* Diagnosis of asthma (according to GINA 2012) for a period of at least 5 years prior screening and prior to the age of 40.
* Increase in FEV1 of * 12% and * 200 mLs within 30 minutes after administration of 400 *g salbutamol (or equivalent dose).
* Pre-bronchodilator FEV1 of * 50 and * 80% of predicted.
* Stable dose of a fixed dose ICS and LABA combination for at least 4 weeks prior to screening. Total daily dose of ICS of * 800 *g/day of budesonide or equivalent.
* Symptomatic with a mean ACQ-5 score * 1.5 at Visit 101 and Visit 102.
* A documented history of one or more asthma exacerbations in the previous 12 months. See protocol page 22 for details.
Exclusion criteria
* ECG abnormalities. See protocol page 23 for details.
* Prohibited medications. See protocol page 30-31 for details.
* Pregnancy, lactation.
* Females of childbearing potential not using adequate contraception. See protocol page 23 for details.
* Type 1 or 2 uncontrolled diabetes.
* BMI of more than 40 kg/m2.
* Asthma exacerbation in the 6 weeks prior to screening. See protocol page 24 items 13-14 for details.
* Respiratory tract infection in the 4 weeks prior to screening. See protocol page 24 items 15-16 for details.
* Smoking in the past 6 months or smoking history of more than 10 pack years.
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 |
|---|---|
| Other | clinicaltrials.gov; registratienummer n.n.b. |
| EudraCT | EUCTR2013-002664-10-NL |
| CCMO | NL47756.060.14 |