A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma

NCT02040779 | Completed Phase 3 Results

• 1 other identifier: BDB-AS-304
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 47

Brief Summary

This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study

Conditions

Persistent Asthma

Keywords

asthma; breath-actuated inhaler; beclomethasone

Outcome Measures

Primary Outcomes (1)

• Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received

  The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'. The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment.

  Baseline (Day 1 predose), weeks 2, 4, 8 and 12

Secondary Outcomes (9)

• Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period

  Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

• Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

  Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

• Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12

  Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

• Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period

  Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

• Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

  Treatment period: daily from Day 1 up to Week 12

Study Arms (3)

BDP 80 mcg BAI

EXPERIMENTAL

40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day.

Drug: Beclomethasone dipropionate breath-actuated inhaler; Drug: albuterol/salbutamol

BDP 160 mcg BAI

EXPERIMENTAL

80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day.

Drug: Beclomethasone dipropionate breath-actuated inhaler; Drug: albuterol/salbutamol

Placebo BAI

PLACEBO COMPARATOR

Placebo breath-actuated inhaler (BAI) twice daily.

Drug: Placebo breath-actuated inhaler; Drug: albuterol/salbutamol

Interventions

Beclomethasone dipropionate breath-actuated inhaler DRUG

Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

Also known as: BDP

BDP 160 mcg BAI; BDP 80 mcg BAI

Placebo breath-actuated inhaler DRUG

Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.

Placebo BAI

albuterol/salbutamol DRUG

Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period

Also known as: bronchodilators

BDP 160 mcg BAI; BDP 80 mcg BAI; Placebo BAI

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Severity of Disease: The patient has persistent asthma, with an 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) reference values at screening visit (SV) (Hankinson et al 1999).
• Current asthma therapy: The patient is currently being treated with 1 of the following:
• \) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV).
• Reversibility of disease: The patient has demonstrated at least 15% 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 SV 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 hypercapnea, respiratory arrest, or hypoxic seizures.
• The patient is a pregnant or lactating female or plans to become pregnant.
• 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 may not have used tobacco products within the past year.
• The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV.
• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (47)

Teva Investigational Site 12813

Huntington Beach, California, United States

Location

Teva Investigational Site 10944

Mission Viejo, California, United States

Location

Teva Investigational Site 10946

Orange, California, United States

Location

Teva Investigational Site 10963

Rolling Hills Estates, California, United States

Location

Teva Investigational Site 10960

San Diego, California, United States

Location

Teva Investigational Site 10973

San Diego, California, United States

Location

Teva Investigational Site 10975

San Jose, California, United States

Location

Teva Investigational Site 10948

Centennial, Colorado, United States

Location

Teva Investigational Site 10958

Centennial, Colorado, United States

Location

Teva Investigational Site 10957

Colorado Springs, Colorado, United States

Location

Teva Investigational Site 12814

Sarasota, Florida, United States

Location

Teva Investigational Site 10962

Tallahassee, Florida, United States

Location

Teva Investigational Site 12809

Savannah, Georgia, United States

Location

Teva Investigational Site 10947

Indianapolis, Indiana, United States

Location

Teva Investigational Site 10943

Iowa City, Iowa, United States

Location

Teva Investigational Site 10954

Baltimore, Maryland, United States

Location

Teva Investigational Site 12940

Bethesda, Maryland, United States

Location

Teva Investigational Site 10955

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 10941

Minneapolis, Minnesota, United States

Location

Teva Investigational Site 10970

Columbia, Missouri, United States

Location

Teva Investigational Site 10968

Rolla, Missouri, United States

Location

Teva Investigational Site 10972

Bozeman, Montana, United States

Location

Teva Investigational Site 12941

Missoula, Montana, United States

Location

Teva Investigational Site 10942

Bellevue, Nebraska, United States

Location

Teva Investigational Site 10959

Skillman, New Jersey, United States

Location

Teva Investigational Site 10945

Raleigh, North Carolina, United States

Location

Teva Investigational Site 12810

Cincinnati, Ohio, United States

Location

Teva Investigational Site 10974

Sylvania, Ohio, United States

Location

Teva Investigational Site 12805

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 12942

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10951

Tulsa, Oklahoma, United States

Location

Teva Investigational Site 10940

Lake Oswego, Oregon, United States

Location

Teva Investigational Site 10952

Medford, Oregon, United States

Location

Teva Investigational Site 10956

Portland, Oregon, United States

Location

Teva Investigational Site 12939

Pittsburgh, Pennsylvania, United States

Location

Teva Investigational Site 12806

Orangeburg, South Carolina, United States

Location

Teva Investigational Site 12811

Knoxville, Tennessee, United States

Location

Teva Investigational Site 10969

Austin, Texas, United States

Location

Teva Investigational Site 12812

Boerne, Texas, United States

Location

Teva Investigational Site 10949

Dallas, Texas, United States

Location

Teva Investigational Site 10953

El Paso, Texas, United States

Location

Teva Investigational Site 12807

Houston, Texas, United States

Location

Teva Investigational Site 10950

New Braunfels, Texas, United States

Location

Teva Investigational Site 10961

San Antonio, Texas, United States

Location

Teva Investigational Site 12808

Waco, Texas, United States

Location

Teva Investigational Site 10967

Seattle, Washington, United States

Location

Teva Investigational Site 10964

Greenfield, Wisconsin, United States

Location

Related Publications (1)

• Hampel FC Jr, Carr W, Gillespie M, Small CJ. Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered via a breath-actuated inhaler for persistent asthma. Allergy Asthma Proc. 2017 Nov 8;38(6):419-430. doi: 10.2500/aap.2017.38.4089. Epub 2017 Sep 8.

  PMID: 28886758 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Albuterol; Bronchodilator Agents

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Asthmatic Agents; Respiratory System Agents; Therapeutic Uses

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Medical Director, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2014
• First Posted: January 20, 2014
• Study Start: December 26, 2013
• Primary Completion: December 24, 2014
• Study Completion: December 24, 2014
• Last Updated: November 9, 2021
• Results First Posted: December 11, 2017

Record last verified: 2021-11

Locations

US (47)