Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

NCT02513160 | Completed Phase 3 Results

• 2 other identifiers: BDB-AS-300392015-002510-80
• Study Type: interventional
• Target: 713
• Locations: 1 country
• Sites: 75

Brief Summary

The primary objective of this study is to evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320 or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) area under the effect curve from time 0 to 6 weeks (AUEC\[0-6wk\]).

Conditions

Persistent Asthma

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 6 Weeks (AUEC(0-6wk))

  The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-6wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit, each treatment visit (Weeks 2, 4 and 6) and any unscheduled visit (such as the early termination visit). The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used. 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 0 of Treatment Period), weeks 2, 4, 6

Secondary Outcomes (6)

• Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 6-Week Treatment Period

  Timeframes: Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks

• Change From Baseline in Weekly Average of Daily Trough Morning Forced Expiratory Volume in One Minute (FEV1) Rate Over the 6-Week Treatment Period

  Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks

• Change From Baseline in Weekly Average of Total Daily (24-Hour) Rescue Medication Use Over the 6-Week Treatment Period

  Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks

• Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 6-Week Treatment Period

  Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks

• Count of Participants Withdrawn From Study Drug Treatment Due to Meeting Stopping Criteria for Worsening Asthma

  Day 0 to Week 6

Study Arms (4)

Beclomethasone dipropionate BAI 320

EXPERIMENTAL

Beclomethasone Dipropionate Delivered via Breath-Actuated Inhaler (BAI) at 320 mcg/day (40 mcg/inhalation, 4 inhalations twice daily) Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.

Drug: Beclomethasone dipropionate via 320 mcg BAI; Drug: albuterol/salbutamol

Beclomethasone dipropionate BAI 640

EXPERIMENTAL

Beclomethasone Dipropionate Delivered via Breath-Actuated Inhaler (BAI) at 640 mcg/day (80 mcg/inhalation, 4 inhalations twice daily) Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.

Drug: Beclomethasone Dipropionate 640; Drug: albuterol/salbutamol

Beclomethasone dipropionate MDI 320

ACTIVE COMPARATOR

Beclomethasone dipropionate Metered Dose Inhaler (MDI) 320 mcg/day (40 mcg/inhalation, 4 inhalations twice daily) Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.

Drug: albuterol/salbutamol; Drug: Beclomethasone dipropionate via 320 mcg MDI

Placebo

PLACEBO COMPARATOR

Pooled breath-actuated inhaler (BAI) or metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.

Drug: Placebo; Drug: albuterol/salbutamol

Interventions

Beclomethasone Dipropionate 640 DRUG

Beclomethasone Dipropionate 640 mcg BAI

Beclomethasone dipropionate BAI 640

Placebo DRUG

Placebo, taken in the morning and evening each day, was provided in matching BAI and MDI devices. The placebo devices were identical to the devices used to deliver active drug.

Placebo

Beclomethasone dipropionate via 320 mcg BAI DRUG

Beclomethasone dipropionate treatment administered via breath-actuated inhaler (BAI) (320 mcg/day).

Beclomethasone dipropionate BAI 320

albuterol/salbutamol DRUG

Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.

Also known as: ProAir®

Beclomethasone dipropionate BAI 320; Beclomethasone dipropionate BAI 640; Beclomethasone dipropionate MDI 320; Placebo

Beclomethasone dipropionate via 320 mcg MDI DRUG

Beclomethasone dipropionate treatment administered via metered-dose inhaler (MDI) (320 mcg/day).

Also known as: QVAR® Inhalation Aerosol

Beclomethasone dipropionate MDI 320

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:

• The patient has a diagnosis of asthma as defined by the 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.
• The patient has been maintained on stable doses of :
• non-corticosteroid therapy
• inhaled corticosteroid therapy
• Written informed consent/assent is obtained. For adult patients (18 years of age and older, or as applicable per local regulations), the written informed consent form (ICF) must be signed and dated by the patient before conducting any study-related procedure. For minor patients (ages 12 to 17 years, or as applicable per local regulations), the written ICF must be signed and dated by the parent/legal guardian and the written informed assent form must be signed and dated by the patient before conducting any study-related procedure.
• The patient is a male or female 12 years of age or older as of the visit when informed consent/assent is signed (screening or prescreening visit, as applicable). (Note: Age requirements are as specified or allowed by local regulations.)
• The patient is able to perform acceptable and repeatable spirometry
• The patient is able to use an electronic diary after training.
• The patient is able to use devices properly
• If female, patient is currently not pregnant, not breast feeding, nor attempting to become pregnant (for 30 days before the screening visit (SV) and throughout the duration of the study and for 30 days after patient's last study visit) or, is of childbearing potential and not sexually active, has a negative urine pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control
• If male, the patient is willing to commit to an acceptable method of birth control for the duration of the study, is surgically sterile or exclusively has same-sex partner(s).
• The patient does not have any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator.
• The patient/parent/legal guardian is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (eg, dose schedules, visit schedules, procedures, and record keeping).
• The patient, as judged by the investigator, is able to discontinue all asthma medications at the SV.

You may not qualify if:

• Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures, asthma-related syncopal episode(s), or hospitalizations within the past year.
• The patient received systemic corticosteroids within 30 days before the SV (for asthma exacerbation or for other indications).
• The patient has participated in any investigational drug study as a randomized patient within the 30 days (starting at the final visit of that study) preceding SV (or prescreening visit, as applicable), or plans to participate in another investigational drug study at any time during this study.
• The patient has previously participated in a beclomethasone dipropionate breath-actuated inhaler (device) (BAI) study as a randomized patient.
• 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 been treated with any known strong cytochrome inhibitors during the study.
• The patient has been treated with any of the prohibited medications during the prescribed (per protocol) withdrawal periods before the SV.
• 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 (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco).
• The patient has a suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV.
• The patient has a history of alcohol or drug abuse within 2 years preceding SV.
• The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before the SV, or has had any hospitalization for asthma within 3 months before SV.
• The patient has initiated immunotherapy (administered by any route) less than 90 days before the SV or had a dose escalation of immunotherapy less than 30 days before the SV.
• The patient is unable to tolerate or unwilling to comply with the required washout periods and withholding of all applicable medications.
• The patient has untreated oral candidiasis at SV. Patients with clinical visual evidence of oral candidiasis and who agree to receive treatment and comply with appropriate medical monitoring may enter the study.
• The patient is either an employee or an immediate relative of an employee of the clinical investigational center.

Sponsors & Collaborators

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

Study Sites (75)

Teva Investigational Site 13415

Peoria, Arizona, United States

Location

Teva Investigational Site 13389

Downey, California, United States

Location

Teva Investigational Site 13421

Huntington Beach, California, United States

Location

Teva Investigational Site 13434

Huntington Beach, California, United States

Location

Teva Investigational Site 13427

Los Angeles, California, United States

Location

Teva Investigational Site 13386

Mission Viejo, California, United States

Location

Teva Investigational Site 13394

Orange, California, United States

Location

Teva Investigational Site 13417

Riverside, California, United States

Location

Teva Investigational Site 13445

Rolling Hills Estates, California, United States

Location

Teva Investigational Site 13420

San Diego, California, United States

Location

Teva Investigational Site 13443

San Diego, California, United States

Location

Teva Investigational Site 13438

San Jose, California, United States

Location

Teva Investigational Site 13397

Centennial, Colorado, United States

Location

Teva Investigational Site 13454

Denver, Colorado, United States

Location

Teva Investigational Site 13404

Aventura, Florida, United States

Location

Teva Investigational Site 13458

Hialeah, Florida, United States

Location

Teva Investigational Site 13416

Miami, Florida, United States

Location

Teva Investigational Site 13440

Miami, Florida, United States

Location

Teva Investigational Site 13455

Miami, Florida, United States

Location

Teva Investigational Site 13431

Ormond Beach, Florida, United States

Location

Teva Investigational Site 13437

Sarasota, Florida, United States

Location

Teva Investigational Site 13425

Tallahassee, Florida, United States

Location

Teva Investigational Site 13450

Normal, Illinois, United States

Location

Teva Investigational Site 13448

River Forest, Illinois, United States

Location

Teva Investigational Site 13408

Lenexa, Kansas, United States

Location

Teva Investigational Site 13410

Baltimore, Maryland, United States

Location

Teva Investigational Site 13422

Bethesda, Maryland, United States

Location

Teva Investigational Site 13435

Wheaton, Maryland, United States

Location

Teva Investigational Site 13411

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 13398

Plymouth, Minnesota, United States

Location

Teva Investigational Site 13429

Plymouth, Minnesota, United States

Location

Teva Investigational Site 13433

Columbia, Missouri, United States

Location

Teva Investigational Site 13432

Rolla, Missouri, United States

Location

Teva Investigational Site 13414

St Louis, Missouri, United States

Location

Teva Investigational Site 13430

St Louis, Missouri, United States

Location

Teva Investigational Site 13384

Bellevue, Nebraska, United States

Location

Teva Investigational Site 13392

Brick, New Jersey, United States

Location

Teva Investigational Site 13426

Ocean City, New Jersey, United States

Location

Teva Investigational Site 13419

Skillman, New Jersey, United States

Location

Teva Investigational Site 13388

Rochester, New York, United States

Location

Teva Investigational Site 13441

Hickory, North Carolina, United States

Location

Teva Investigational Site 13403

Raleigh, North Carolina, United States

Location

Teva Investigational Site 13405

Wilmington, North Carolina, United States

Location

Teva Investigational Site 13395

Canton, Ohio, United States

Location

Teva Investigational Site 13396

Cincinnati, Ohio, United States

Location

Teva Investigational Site 13436

Sylvania, Ohio, United States

Location

Teva Investigational Site 13423

Toledo, Ohio, United States

Location

Teva Investigational Site 13387

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 13453

Eugene, Oregon, United States

Location

Teva Investigational Site 13439

Lake Oswego, Oregon, United States

Location

Teva Investigational Site 13402

Medford, Oregon, United States

Location

Teva Investigational Site 13412

Portland, Oregon, United States

Location

Teva Investigational Site 13391

Pittsburgh, Pennsylvania, United States

Location

Teva Investigational Site 13449

East Providence, Rhode Island, United States

Location

Teva Investigational Site 13456

Warwick, Rhode Island, United States

Location

Teva Investigational Site 13413

North Charleston, South Carolina, United States

Location

Teva Investigational Site 13390

Knoxville, Tennessee, United States

Location

Teva Investigational Site 13442

Knoxville, Tennessee, United States

Location

Teva Investigational Site 13400

Austin, Texas, United States

Location

Teva Investigational Site 13452

Boerne, Texas, United States

Location

Teva Investigational Site 13407

Dallas, Texas, United States

Location

Teva Investigational Site 13424

Dallas, Texas, United States

Location

Teva Investigational Site 13409

El Paso, Texas, United States

Location

Teva Investigational Site 13451

Houston, Texas, United States

Location

Teva Investigational Site 13399

New Braunfels, Texas, United States

Location

Teva Investigational Site 13393

San Antonio, Texas, United States

Location

Teva Investigational Site 13444

San Antonio, Texas, United States

Location

Teva Investigational Site 13446

San Antonio, Texas, United States

Location

Teva Investigational Site 13457

San Antonio, Texas, United States

Location

Teva Investigational Site 13459

San Antonio, Texas, United States

Location

Teva Investigational Site 13383

Waco, Texas, United States

Location

Teva Investigational Site 13401

South Burlington, Vermont, United States

Location

Teva Investigational Site 13385

Richmond, Virginia, United States

Location

Teva Investigational Site 13447

Richmond, Virginia, United States

Location

Teva Investigational Site 13428

Greenfield, Wisconsin, United States

Location

Related Publications (2)

• Kerwin EM, Hickey L, Small CJ. Relationship between handheld and clinic-based spirometry measurements in asthma patients receiving beclomethasone. Respir Med. 2019 May;151:35-42. doi: 10.1016/j.rmed.2019.03.010. Epub 2019 Mar 20.

  PMID: 31047115 DERIVED

• Ostrom NK, Raphael G, Tillinghast J, Hickey L, Small CJ. Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma. Allergy Asthma Proc. 2018 Mar 9;39(2):117-126. doi: 10.2500/aap.2018.39.4115. Epub 2018 Jan 9.

  PMID: 29317015 DERIVED

MeSH Terms

Interventions

Bays; Albuterol; Procaterol

Intervention Hierarchy (Ancestors)

Oceans and Seas; Geological Phenomena; Physical Phenomena; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

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

ustevatrials@tevapharm.com

1-215-591-3000

Study Officials

• Teva Medical Expert, 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 31, 2015
• Study Start: September 30, 2015
• Primary Completion: March 31, 2016
• Study Completion: March 31, 2016
• Last Updated: November 9, 2021
• Results First Posted: September 11, 2017

Record last verified: 2021-11

Locations

US (75)