A 12-Week study to find out if Fluticasone Propionate and Fluticasone/Salmeterol are safe and effective to treat teenagers and adults with asthma.
- Conditions
- Persistent AsthmaMedDRA version: 18.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-000923-25-HU
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 715
Severity of Disease: The patient has persistent asthma with a FEV1 =
40% and =85% of the value predicted for age, height, sex, and race as
per the National Health and Nutrition Examination Survey III (NHANES
III) reference values at the screening visit (SV).
b. Current Asthma Therapy: Permitted asthma therapies are detailed in
the protocol. Patients will be required to have a treatment regimen that
includes a short-acting ß2-agonist (SABA; albuterol/salbutamol) for use
as needed for a minimum of 8 weeks before the SV. The patient is
required to have a qualifying dose of inhaled corticosteroid (ICS) as part
of their asthma management plan, either as ICS monotherapy or as an
ICS/LABA combination, for a minimum of 1 months before providing
consent. Patients on ICS/LABA combination therapy will require a
prescreening visit in order to change to a comparable dose of ICS
monotherapy. The ICS component of the patient's asthma therapy
should be stable for a minimum of 1 month before the informed consent
is signed. Qualifying doses of ICS are listed in the protocol. Appropriate
medication washouts are noted under the prohibited medications
section.
c. Reversibility of Disease: The patient has demonstrated at least 15%
reversibility (all patients) and at least 200 mL increase from baseline
FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations
of albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler
(MDI) (90 mcg ex-actuator) or equivalent at the SV. Reversibility values
of 14.50-14.99 will be rounded to 15. Note: Patients who do not qualify
for the study due to failure to meet reversibility will be permitted to
perform a retest once within 7 days or will be a screen failure and
permitted to rescreen once at least 7 days after the date of first
screening.
d. Written informed consent/assent is obtained. For adult patients (age
18 years and older, or as
applicable per local regulations), the written informed consent form
(ICF) must be signed and dated by the patient before conducting any
study-related procedure. For minor patients (ages 12 to 17 years, or as
applicable per local regulations), the written ICF must be signed and
dated by the parent/legal guardian and the written assent form must be
signed and dated by the patient (if applicable) before conducting any
study-related procedure. Note: Age requirements are as specified by
local regulations.
e. The patient is a male or female 12 years of age or older, as of the
visit when the ICF/assent form is signed (SV or prescreening visit, as
applicable). In countries where the local regulations or the regulatory
status of study drug permit enrolment of adult patients only, patients
must be 18 years of age and older, as of the date of the ICF/assent form.
f. Asthma diagnosis: The patient has a diagnosis of asthma as defined
by the NIH. The asthma diagnosis has been present for a minimum of 3
months and has been stable for at least 30 days before the ICF is signed.
g. The patient is able to perform acceptable and repeatable spirometry
consistent with the ATS/ERS 2005 criteria. FVC repeatability will not be
required.
h. The patient is able to perform PEF with a handheld peak flow meter.
i. The patient is able to use a MDI device without a spacer device and a
MDPI device.
j. The patient is able to withhold (as judged by the investigator) his or
her regimen of ICS or study drug, and rescue medication for at least 6
hours
The patient has a history of a life-threatening asthma exacerbation that
is defined for this protocol as an asthma episode that required intubation
and/or was associated with hypercapnea, respiratory arrest, or hypoxic
seizures.
b. The patient is pregnant or lactating, or plans to become pregnant
during the study period or for 30 days after the patient's last studyrelated
visit (for eligible patients only, if applicable). Eligible female
patients unwilling to employ appropriate contraceptive measures to
ensure that pregnancy will not occur during the study will be excluded.
Any patient becoming pregnant during the study will be withdrawn from
the study.
c. The patient has participated as a randomized patient in any
investigational drug study within the 30 days (starting from the final
follow-up visit of that study) preceding the SV (or prescreening visit, as
applicable) or plans to participate in another investigational drug study
at any time during this study.
d. The patient has previously participated as a randomized patient in a
study of Fp MDPI or FS MDPI.
e. The patient has a known hypersensitivity to any corticosteroid,
salmeterol, or any of the excipients in the study drug or rescue
medication formulation (ie, lactose).
f. The patient has been treated with any known strong cytochrome
P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, or
clarithromycin) within 30 days before the SV or plans to be treated with
any strong CYP3A4 inhibitor during the study.
g. The patient has been treated with any of the prohibited medications
during the prescribed (per protocol) washout periods before the SV.
h. The patient currently smokes or has a smoking history of 10 packyears
or more (a pack-year is defined as smoking 1 pack of
cigarettes/day for 1 year). The patient must not have used tobacco
products within the past year (eg, cigarettes, cigars, chewing tobacco, or
pipe tobacco).
i. The patient has a culture-documented or suspected bacterial or viral
infection of the upper or lower respiratory tract, sinus, or middle ear that
has not resolved at least 2 weeks before the SV. Note: A patient who
develops an upper respiratory tract infection (URI) or lower respiratory
tract infection (LRI) during the run-in period will be made a screen
failure and may rescreen 2 weeks after symptoms resolve.
j. The patient has a history of alcohol or drug abuse within 2 years
preceding the SV.
k. The patient has had an asthma exacerbation requiring systemic
corticosteroids within 30 days before the SV, or has had any
hospitalization for asthma within 2 months before the SV.
l. Initiation or dose escalation of immunotherapy (administered by any
route) is planned during the study period. However, patients who
initiated immunotherapy 90 days or more before the SV and have been
on a stable (maintenance) dose for 30 days or more before the SV may
be considered for inclusion.
m. The patient has used immunosuppressive medications within 4
weeks before the SV.
n. The patient is unable to tolerate or unwilling to comply with the
appropriate washout periods and withholding of all applicable
medications.
o. The patient has untreated oral candidiasis at the SV. Patients with
clinical visual evidence of oral candidiasis who agree to receive
treatment and comply with appropriate medical monitoring may enter
the study. Note: Azole antifungals are prohibited.
p. The patient has a history of a positive test for
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method