A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo. Patients took 1 inhalation (with assistance from parents/guardians/caregivers, as needed) from each of 2 devices (BAI device followed by MDI device in that order) twice daily as per the double-dummy study design: 1 BAI treatment or placebo device and 1 MDI treatment or placebo device for a total of 2 inhalations each time.

Key facts

Study ID

NCT02040766

Run by

Teva Branded Pharmaceutical Products R&D, Inc.

People needed

628

Starts

2013-12-01

Expected to finish

2016-03-01

Last updated by the study team

2021-11-09

Who can join

Age: 4 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institute 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 screening visit
• Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40% to 90% of the value predicted for age, height, and sex at screening visit (SV)
• Current asthma therapy: The patient is currently being treated with 1 of the following: 1) a stable daily dosage of an inhaled corticosteroid (ICS) in the range of 88-176 mcg/day of fluticasone propionate (or equivalent) for a minimum of 4 weeks (28 days) before screening visit 2) a stable daily dosage of non-corticosteroid therapy 3) a daily dose of ICS plus a long-acting beta2-agonist (LABA) (at a dose less than or equivalent to fluticasone propionate 100 mcg/salmeterol 50 mcg twice daily)
• Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at screening visit or on retesting.
• 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 hypercapnia, 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). 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 has used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco, as applicable).
• The patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before screening visit, or has had any hospitalization for asthma within 2 months before 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 12294 — Montgomery, Alabama, United States
• Teva Investigational Site 10925 — Phoenix, Arizona, United States
• Teva Investigational Site 12349 — Little Rock, Arkansas, United States
• Teva Investigational Site 10903 — Costa Mesa, California, United States
• Teva Investigational Site 10911 — Downey, California, United States
• Teva Investigational Site 10901 — Huntington Beach, California, United States
• Teva Investigational Site 12297 — Huntington Beach, California, United States
• Teva Investigational Site 10880 — Mission Viejo, California, United States
• Teva Investigational Site 10895 — Orange, California, United States
• Teva Investigational Site 10924 — Paramount, California, United States
• Teva Investigational Site 10910 — Rolling Hills Estates, California, United States
• Teva Investigational Site 12343 — Roseville, California, United States
• Teva Investigational Site 12298 — San Diego, California, United States
• Teva Investigational Site 12300 — San Diego, California, United States
• Teva Investigational Site 12295 — San Jose, California, United States
• Teva Investigational Site 12312 — West Covina, California, United States
• Teva Investigational Site 10937 — Centennial, Colorado, United States
• Teva Investigational Site 10899 — Colorado Springs, Colorado, United States
• Teva Investigational Site 10894 — Aventura, Florida, United States
• Teva Investigational Site 12335 — Gainesville, Florida, United States
• Teva Investigational Site 12336 — Homestead, Florida, United States
• Teva Investigational Site 12345 — Homestead, Florida, United States
• Teva Investigational Site 12315 — Miami, Florida, United States
• Teva Investigational Site 12341 — Miami, Florida, United States
• Teva Investigational Site 12346 — Hoover, Alabama, United States

Full record on ClinicalTrials.gov

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