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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 November 2021
• Main ID: NCT02040766
• Date of registration: 16/01/2014
• Prospective Registration: No
• Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Public title: 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
• Scientific title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 80 or 160 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Pediatric Patients 4 Through 11 Years of Age With Persistent Asthma
• Date of first enrolment: December 2013
• Target sample size: 628
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02040766
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Chile, Colombia, Croatia, Ecuador, El Salvador, Guatemala, Israel, Lithuania, Mexico, Panama, Peru, Poland, Romania, Serbia, Ukraine, United States

Contacts

• Name: Teva Medical Expert, MD
• Affiliation: Teva Branded Pharmaceutical Products R&D, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

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 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



Age minimum: 4 Years
Age maximum: 11 Years
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Beclomethasone dipropionate MDI

Drug: Placebo BAI

Drug: albuterol/salbutamol 90 mcg

Drug: Placebo MDI

Drug: Beclomethasone dipropionate BAI

Primary Outcome(s)

Standardized Baseline-adjusted Trough Morning Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk)) [Time Frame: Day 1 (baseline), Weeks 2, 4, 8, 12]

Secondary Outcome(s)

Kaplan-Meier Estimates For Time to Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-week Treatment Period [Time Frame: Day 1 to 12 weeks]

Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12 [Time Frame: Day 1 (baseline), weeks 1-12]

Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period [Time Frame: Day 1 (baseline), weeks 1-12]

Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 [Time Frame: Day 1 (baseline), weeks 1-12]

Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period [Time Frame: Day 1 (baseline), weeks 1-12]

Secondary ID(s)

2013-004632-30

BDB-AS-302

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/02/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02040766