A 12 Week Study to the Effectivenes and Safety Of 2 doses of Beclomethasone Dipropionate using a Breath Actuated Inhaler (BAI) or Metered Dose Inhaler (MDI) in Adolescent and Adult Patients 12 Years of Age and Older with Persistent Asthma
- Conditions
- Persistent AsthmaTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-003397-27-PL
- 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
- 500
a. Severity of disease: The patient has persistent asthma, with an FEV1 40% 85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at the screening visit (SV).
b. Current asthma therapy: The patient must be on a stable dose of an inhaled corticosteroid (ICS) of at least 440 mcg/day of fluticasone propionate or equivalent for a minimum of 4 weeks before SV, or any ICS/long acting ß2 agonist (LABA) combination for a minimum of 4 weeks before the prescreening visit.
c. Reversibility of disease: The patient has demonstrated at least 12% reversibility and 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2 4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex actuator) or equivalent at SV. Reversibility values of 11.50 11.99 will be rounded to 12. A documented historical reversibility, including flow loops, of at least 12% and 200 mL increase from baseline FEV1 (patients age 18 and older) to a beta agonist in the previous 12 months before SV is also acceptable. Note: Patients who do not qualify for the study due to either failure to meet baseline spirometry, failure to meet reversibility, or failure to achieve spirometry consistent with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria will be permitted to perform a retest once within 7 days or will be permitted to rescreen once at least 7 days after the date of screening.
d. Written informed consent/assent is obtained. For adult patients (age 18 and older, or as applicable per local regulations), the written informed consent form 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 informed consent form must be signed and dated by the parent/legal guardian and the written informed assent form must be signed and dated by the patient before conducting any study related procedure.
e. The patient is a male or female 12 years of age or older as of the visit when informed consent/assent is signed (screening or prescreening visit, as applicable).
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.
g. The patient is able to perform acceptable and repeatable spirometry consistent with the ATS/ERS 2005 criteria.
h. The patient is able to perform PEF with a hand held peak flow meter.
i. The patient is able to use an MDI device without a spacer device and a BAI 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 SV and the treatment visits in which spirometry will be conducted (SV, randomization visit [RV], treatment visit [TV] 1, TV2, TV3, and TV4).
k. The patient/parent/guardian/caregiver is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements.
l. If patient is a female, she is currently not pregnant, breast feeding, or attempting to become pregnant (for 30 days before SV and throughout the duration of the study and for 30 days
a. The patient has a history of life threatening asthma, 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 or to donate gametes (ova or sperm) for in vitro fertilization 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 in any investigational drug study within the 30 days preceding 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 in a beclomethasone dipropionate BAI study as a randomized patient.
e. The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
f. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors (eg, azole antifungals, ritonavir, clarithromycin) within 30 days before 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 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). A 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 SV.
j. The patient has a history of alcohol or drug abuse within 2 years preceding SV.
k. The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before 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 screening visit (SV) and have been on a stable (maintenance) dose for 30 days or more prior to SV may be considered for inclusion.
m. The patient has used immunosuppressive medications within 4 weeks before SV.
n. The patient is unable to tolerate or unwilling to comply with the required washout periods and withholding of all applicable medications.
o. The patient has untreated oral candidiasis at SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the study.
p. The patient has had a positive test for human immunodeficiency virus (HIV), active hepatitis B virus, or hepatitis C infection.
q. The patient is either an employee or an immediate relative of an employee of the clinical investigational center.
r. A member of the patient’s household is participating in the study at the same time.
s. The patient has historic or current evidence of a clinically significant disease, including but
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