A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.

Key facts

Study ID

NCT02031640

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

1113

Starts

2013-12-01

Expected to finish

2014-12-01

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…

• Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) (Hankinson et al 1999) reference values at screening visit.
• 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 screening visit, or any inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combination for a minimum of 4 weeks before the prescreening visit.
• Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 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) MDI (90 mcg ex-actuator) or equivalent at the screening visit
• If female, the patient is currently not pregnant, breast feeding, or attempting to become pregnant. If of childbearing potential, has a negative serum pregnancy test and is willing to commit to using a consistent and acceptable method of birth control.
• Other criteria apply, please contact the investigator for more information

You may not qualify if…

• 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.
• 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.
• The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
• 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 has had an asthma exacerbation requiring oral corticosteroids within 30 days before the screening visit, or has had any hospitalization for asthma within 2 months before the screening visit.
• The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease 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 apply, please contact the investigator for more information

Where it is running

• Teva Investigational Site 10849 — Huntington Beach, California, United States
• Teva Investigational Site 10872 — Huntington Beach, California, United States
• Teva Investigational Site 10833 — Long Beach, California, United States
• Teva Investigational Site 10861 — Los Angeles, California, United States
• Teva Investigational Site 10798 — Mission Viejo, California, United States
• Teva Investigational Site 10806 — Orange, California, United States
• Teva Investigational Site 10828 — Orange, California, United States
• Teva Investigational Site 10860 — Paramount, California, United States
• Teva Investigational Site 10813 — Rancho Mirage, California, United States
• Teva Investigational Site 10843 — Riverside, California, United States
• Teva Investigational Site 10857 — Rolling Hills Estates, California, United States
• Teva Investigational Site 10847 — San Diego, California, United States
• Teva Investigational Site 10871 — San Diego, California, United States
• Teva Investigational Site 10876 — San Jose, California, United States
• Teva Investigational Site 12270 — Walnut Creek, California, United States
• Teva Investigational Site 12266 — Centennial, Colorado, United States
• Teva Investigational Site 10838 — Colorado Springs, Colorado, United States
• Teva Investigational Site 10844 — Denver, Colorado, United States
• Teva Investigational Site 10799 — Wheat Ridge, Colorado, United States
• Teva Investigational Site 10826 — Aventura, Florida, United States
• Teva Investigational Site 10877 — Clearwater, Florida, United States
• Teva Investigational Site 10816 — Edgewater, Florida, United States
• Teva Investigational Site 12268 — Melbourne, Florida, United States
• Teva Investigational Site 10807 — Miami, Florida, United States
• Teva Investigational Site 10851 — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

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