A 12-Week study to find out if Fluticasone Propionate 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
- EUCTR2014-001149-25-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
- 625
Severity of Disease: Patient has persistent asthma with a FEV1 =40%
and =85% of the value predicted for age, height, sex, and race as per
short-acting ß2-agonist for use as needed for a minimum of 8 weeks
before SV. Patient required to have a low dose or mid-dose inhaled
corticosteroid as part of their asthma management plan for a minimum
of 1 month 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(Section 3.11.1). ICS component of
the patient's asthma therapy should be stable for a minimum of 1 month
before providing informed consent. Qualifying doses of ICS are listed in
the protocol. Appropriate medication washouts noted under 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 issigned (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 (defined as no exacerbations and no
changes in medication) for at least 30 days before providing informed
consent.
g.The patient is able to perform acceptable and repeatable spirometry
consistent with the American Thoracic Society (ATS)/European
Respiratory Society Task Force (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 before the SV and before all treatment visits where spirometry is
performed.
k.The patient/parent/legal guardian/caregiver is capable of
understanding the requirements, risks, and benefits of study
participation, and, as judged by the investigator,
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 study-related 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. Applicable studies are listed in Section 1.5.
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 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may 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: Patients who develop 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 tes
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