Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma

Completed · Phase 3

Conditions studied: Persistent Asthma

In brief

The primary objective of the study is to evaluate the long-term safety of fluticasone propionate (Fp) inhalation powder in 2 strengths and fluticasone propionate/salmeterol inhalation (FS) powder in 2 strengths when administered with the Teva multidose dry powder inhaler (MDPI) device over 26 weeks in patients with persistent asthma.

Key facts

Study ID

NCT02175771

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

758

Starts

2014-07-01

Expected to finish

2015-07-01

Last updated by the study team

2021-11-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Best pre-bronchodilator forced expiratory volume in 1 second (FEV1) of greater than 40% of their predicted normal value.
• Patients must have a treatment regimen that includes a short-acting β2 agonist (SABA) (albuterol) for use as needed and either an inhaled corticosteroid (ICS) or an ICS/long-acting β2 agonist (LABA) as a preventative treatment for a minimum of 8 weeks before the SV. Patients currently taking low-dose ICS without LABA are not eligible for this study. Patients currently taking low-dose ICS/LABA may only be entered into the mid ICS strength. All patients must have been maintained on a stable dose of ICS or ICS/LABA for 4 weeks prior to the SV (or pre-SV if necessary) at 1 qualifying doses
• To meet reversibility of disease criteria, the patient must demonstrate a ≥12% reversibility of FEV1 (and 200 mL for patients aged18 years and older) within 30 minutes following 4 inhalations of albuterol at the SV. Historic reversibility within the past 12 months of the SV may be used to meet this criterion.
• Written informed consent/assent is obtained. For adult patients (aged 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 (aged 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.
• Outpatient >= 12 years of age on the date of consent/assent. .
• Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institutes of Health (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.
• The patient is able to perform acceptable and repeatable spirometry.
• The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow meter.
• The patient is able to use a metered-dose inhaler (MDI) device without a spacer device and a MDPI device.
• 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.
• The patient/parent/legal 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.
• SABAs: All patients must be able to replace their current SABA with albuterol/salbutamol HFA inhalation aerosol at the SV for use as needed for the duration of the study.
• Female patients may not be pregnant, breastfeeding, or attempting to become pregnant.
• -Other criteria may apply, please contact the investigator for more information

You may not qualify if…

• 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.
• The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study.
• The patient has participated as a randomized patient in any investigational drug study within the 30 days preceding the SV (or prescreening visit, as applicable) or plans to participate in another investigational drug study at any time during this study.
• The patient has previously participated in an Fp MDPI or FS MDPI study.
• 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).
• 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.
• The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV.
• 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).
• 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.
• The patient has a history of alcohol or drug abuse within 2 years preceding the SV.
• 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.
• 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.
• The patient has used immunosuppressive medications within 4 weeks before the SV.
• The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications. (Patients that require continuous treatment with β-blockers, monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and/or systemic corticosteroids are excluded).
• 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.
• The patient has a history of a positive test for human immunodeficiency virus, active hepatitis B virus, or hepatitis C infection.
• The patient is either an employee or an immediate relative of an employee of the clinical investigational center.
• A member of the patient's household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened.
• The patient has a disease/condition that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
• Other criteria may apply, please contact the investigator for more information
• Criteria for Randomization:
• Patients were randomized into the study if they met all of the following criteria:
• The patient continued to be in general good health, meeting the entry criteria.
• The patient continued to have a predose/pre-albuterol FEV1 at the randomization visit (RV) that was ≥40% of predicted normal.
• The patient had no clinically significant abnormal laboratory test results or ECG findings at the screening visit.

Where it is running

• Teva Investigational Site 12112 — Mobile, Alabama, United States
• Teva Investigational Site 12130 — Pell City, Alabama, United States
• Teva Investigational Site 12119 — Little Rock, Alaska, United States
• Teva Investigational Site 12076 — Phoenix, Arizona, United States
• Teva Investigational Site 12135 — Scottsdale, Arizona, United States
• Teva Investigational Site 12132 — Tucson, Arizona, United States
• Teva Investigational Site 12102 — Fountain Valley, California, United States
• Teva Investigational Site 12104 — Fresno, California, United States
• Teva Investigational Site 12123 — Fullerton, California, United States
• Teva Investigational Site 12103 — Huntington Beach, California, United States
• Teva Investigational Site 12073 — Long Beach, California, United States
• Teva Investigational Site 12077 — Mission Viejo, California, United States
• Teva Investigational Site 12098 — Napa, California, United States
• Teva Investigational Site 12149 — Northridge, California, United States
• Teva Investigational Site 12081 — Orange, California, United States
• Teva Investigational Site 12100 — Rancho Mirage, California, United States
• Teva Investigational Site 12133 — Riverside, California, United States
• Teva Investigational Site 12146 — Riverside, California, United States
• Teva Investigational Site 12075 — Rolling Hills Estates, California, United States
• Teva Investigational Site 12074 — San Diego, California, United States
• Teva Investigational Site 12150 — San Diego, California, United States
• Teva Investigational Site 12064 — San Jose, California, United States
• Teva Investigational Site 12061 — Stockton, California, United States
• Teva Investigational Site 12141 — Walnut Creek, California, United States
• Teva Investigational Site 12068 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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