The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed. The secondary objectives of…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* adverse events will be evaluated throughout the study
* chemistry, hematology, and urinalysis tests (except for urine beta human
chorionic gonadotropin
[*-HCG] test conducted predose every 4 weeks) will be performed at baseline
(end-of-treatment visit
of previous double-blind study), at weeks 4, 8, and 24, and every 24 weeks
thereafter until
end-of-treatment visit/early termination, and 90 days after the
end-of-treatment visit for blood
eosinophils.
* vital sign measurements, brief physical examinations, and concomitant
medication usage will be
assessed every 4 weeks throughout the study, and 90 days after the
end-of-treatment visit.
* antibodies to reslizumab will be assessed every 24 weeks until
end-of-treatment visit/early
termination
Secondary outcome
* change from baseline in pulmonary function test results as measured by FEV1,
%FEV1, FVC, and
FEF25-75% every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks
thereafter until
end-of-treatment visit, or early termination
* change from baseline in beta-agonist use every 4 weeks for 16 weeks, at 24
weeks, and every 12
weeks thereafter until end-of-treatment visit, or early termination
* change from baseline in ASUI every 4 weeks for 16 weeks, at 24 weeks, and
every 12 weeks
thereafter until end-of-treatment visit, or early termination
* change from baseline in ACQ score every 4 weeks for 16 weeks, at 24 weeks,
and every 12 weeks
thereafter until end-of-treatment visit, or early termination
* change from baseline in AQLQ score every 24 weeks until end-of-treatment
visit, or early termination
Background summary
Some individuals have a type of asthma made worse by an unusual increase in
white blood cells in their lungs which may cause chronic airway inflammation.
These cells are called eosinophils and may be caused by high levels of a normal
protein called interleukin 5 (IL 5). Researchers hope that reslizumab blocks
the action of the IL 5 protein and therefore lowers the level of these white
blood cells in the lungs.
Reslizumab is an investigational drug, a drug that is being tested and is not
approved for sale yet. Researchers hope that Reslizumab improves asthma control
in subjects with active asthma and eosinophilic airway inflammation. In an
earlier research the action of Reslizumab has been compared with placebo.
This is an open-label extension study. Patients will receive the same 4-weeks
treatment as in the 3081 study, for 2 additional years after they start with
the extension phase.
Study objective
The primary objective of the study is to evaluate the long-term safety of
reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months
in pediatric and adult patients with eosinophilic asthma as assessed. The
secondary objectives of the study are as follows:
* pulmonary function test results, as measured by forced expiratory volume in 1
second (FEV1), percent
predicted forced expiratory volume in 1 second [%FEV1], forced vital capacity
(FVC), forced
expiratory flow at 25% to75% FVC (FEF25-75%) every 4 weeks for 16 weeks, at 24
weeks, and every
12 weeks thereafter throughout the study
* beta-agonist use every 4 weeks for 16 weeks, at 24 weeks, and every 12 weeks
thereafter throughout
the study
* asthma symptom score (Asthma Symptom Utility Index [ASUI]) every 4 weeks for
16 weeks, at
24 weeks, and every 12 weeks thereafter throughout the study
* Asthma Control Questionnaire (ACQ) every 4 weeks for 16 weeks, at 24 weeks,
and every 12 weeks
thereafter throughout the study
* Asthma Quality of Life Questionnaire (AQLQ) every 24 weeks throughout the
study
Study design
Phase III, open-label extension study
Intervention
Reslizumab (3,0 mg/kg) every 28 days (±7 days), for approximately 24 months
intravenously by infusion.
Study burden and risks
Reslizumab can have the following side-effects: headache; fatigue (feeling
tired); nausea; upper respiratory tract infection (i.e., cold symptoms);
myalgia (muscle tenderness or pain).
Summary of procedures:
- short physical exam (each visit, at screening/baseline and end of study visit
an extended physical exam will be performed)
- length and weight (every 16 weeks)
- measurement of vital signs ( each visit)
- lung function tests ( visit 1 - 5, 7, and further every 12 weeks)
- blood tests for lab study ( visit 1 - 3, 7, and further every 24 weeks)
- urine pregnancy test (every visit)
- questionnaires regarding asthma symptoms (visit 1 - 5, 7, and further every
12 weeks)
- urine analysis (visit 1 - 3, 7, 13, and further every 24 weeks)
41 Moores Drive, Aegon Building
PA 19355 Frazer
US
41 Moores Drive, Aegon Building
PA 19355 Frazer
US
Listed location countries
Age
Inclusion criteria
(a) The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma and who completed treatment in a Cephalon-sponsored, double-blind, placebo-controlled study in patients with eosinophilic asthma.
(b) Patient must have completed treatment in a previous Cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
(c) The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
Exclusion criteria
- The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient*s safety.
- The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
- The patient is a current smoker.
- The patient has a current infection or disease that may preclude assessment of asthma.
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 | EUCTR2010-024540-15-NL |
| ClinicalTrials.gov | NCT01290887 |
| CCMO | NL35342.096.11 |