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

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Beclomethasone dipropionate; Drug: Albuterol/salbutamol; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02031640

2013-003397-27 (EudraCT Number)

BDB-AS-301

Details and patient eligibility

About

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.

Enrollment: 1,113 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

1,113 participants in 5 patient groups, including a placebo group

BDP 320 mcg BAI

Experimental group

Description:

Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.

Treatment:

Drug: Albuterol/salbutamol

Drug: Placebo

Drug: Beclomethasone dipropionate

BDP 640 mcg BAI

Experimental group

Description:

Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.

Treatment:

Drug: Albuterol/salbutamol

Drug: Placebo

Drug: Beclomethasone dipropionate

BDP 320 mcg MDI

Active Comparator group

Description:

Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.

Treatment:

Drug: Albuterol/salbutamol

Drug: Placebo

Drug: Beclomethasone dipropionate

BDP 640 mcg MDI

Active Comparator group

Description:

Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.

Treatment:

Drug: Albuterol/salbutamol

Drug: Placebo

Drug: Beclomethasone dipropionate

Placebo BAI and MDI

Placebo Comparator group

Description:

Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.

Treatment:

Drug: Albuterol/salbutamol

Drug: Placebo