Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Persistent Asthma

NCT03834012 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: APC-1000-02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Approximately 480 (120 per group) would need to complete the 6 weeks of treatments.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Change from baseline in FEV1 percent predicted compared to placebo

  The primary analysis of change from baseline trough (pre-dose and pre-rescue bronchodilator) FEV1 percent predicted (0-6 weeks) will be carried out on the mITT Population using analysis of covariance (ANCOVA) with treatment as an effect, and status of previous steroid use (naïve or prior use) as the covariate. The efficacy endpoint for the primary analysis is the change from baseline trough FEV1%- predicted at week 6.

  6 weeks

Secondary Outcomes (1)

• AUC at week in FEV1 compared to placebo

  6 weeks

Study Arms (4)

Beclomethasone 800 µg per day

EXPERIMENTAL

Intervention: Drug: Beclomethasone 800 ug per day Daily dose of Beclomethasone 800 ug 4 inhalations 100 μg ex-valve 2 times a day for 6 weeks

Drug: Beclomethasone 800 µg per day

Beclomethasone 640 µg per day

ACTIVE COMPARATOR

Intervention: Drug: Beclomethasone 640 µg per day 4 inhalations 80 μg ex-actuator 2 times a day for 6 weeks

Drug: Beclomethasone 640 µg per day

Placebo

PLACEBO COMPARATOR

Intervention: Drug: placebo 4 inhalations 2 times a day for 6 weeks

Drug: Placebo

Beclomethasone 400 µg per day

EXPERIMENTAL

Intervention: Drug: Beclomethasone 400 µg per day Daily dose of Beclomethasone 400 µg 2 inhalations 100 μg ex-valve 2 times a day for 6 weeks Intervention: Drug: Placebo 2 inhalations 2 times a day for 6 weeks

Drug: Placebo; Drug: Beclomethasone 400 µg per day

Interventions

Beclomethasone 800 µg per day DRUG

Intervention: Drug: Beclomethasone 800 µg HFA per day

Also known as: Beclomethasone Dipropionate HFA

Beclomethasone 800 µg per day

Placebo DRUG

Intervention: Drug: placebo

Also known as: Placebo for Beclomethasone Dipropionate HFA

Beclomethasone 400 µg per day; Placebo

Beclomethasone 400 µg per day DRUG

Intervention: Drug: Beclomethasone 400 µg HFA per day

Also known as: Beclomethasone Dipropionate HFA

Beclomethasone 400 µg per day

Beclomethasone 640 µg per day DRUG

Intervention: Drug: Beclomethasone 640 µg per day

Also known as: QVAR

Beclomethasone 640 µg per day

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects (between ≥ 12 and ≤ 80 years old). Females may be of either childbearing or non-childbearing potential. All females of childbearing potential must be either abstinent from sexual intercourse or using adequate contraception and must also have a negative pregnancy test. Pregnant or nursing females or females intending to become pregnant during the course of the study must be excluded from the study.
• The subject has persistent asthma as defined by the National Asthma Education a Prevention Program (NAEPP ERP-3 (1)) at least 12 weeks prior to screening.
• Pre-bronchodilator forced expiratory volume in 1 second (FEV1) on the screening visit and on the baseline visit is \>40% of the predicted value according to age, height, race and sex using The global lung function 2012 equations: Report of the Global Lung Function Initiative (GLI), following abstinence from short-acting β-agonists for a minimum of 6 hours and withholding restricted medications prior to the visits. At Visit 2 the baseline FEV1 and the predicted FEV1 value would be the mean of 2 pre-dose FEV1 measurements taken 30 minutes apart (-30 min and 0).
• The subject has demonstrated at least 12% reversibility of FEV1 at either the screening or baseline visit within 30 minutes after 4 inhalations (total of 360 μg) of albuterol (pMDI). \[Note: Subjects who fail to demonstrate the required reversibility at the Screening Visit (Visit 1) are eligible to enter the Run-in Period and repeat the testing at the End of Run-in Period/Baseline (Visit 2)\].
• If the subject is on inhaled corticosteroids the subject must be on a stable dose of daily-inhaled corticosteroid (ICS) at least 160 μg/day of beclomethasone dipropionate or equivalent for a minimum of 4 weeks before screening visit (Estimated comparative daily doses for ICSs for youths ≥12 years of age and adults per NAEPP ERP-3).
• Currently nonsmoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack years of historical use.
• A body mass index between 18-35 kg/m2, inclusive.
• Willingness to give their written informed consent/assent to participate in the study.
• Subjects must be able to perform acceptable and repeatable spirometry, Peak Flow Meter (twice a day measurements), keep a diary record and to use the inhalation devices as assessed at Screening and Baseline by the study staff.
• Ability to understand and comply with the protocol requirements, instructions and protocol stated restrictions.
• NOTE: At the end of the placebo Run-in period the subject will be stratified into two categories:
• Corticosteroid naïve subjects (Not have taken inhaled corticosteroids (ICSs) at least 3 months prior to screening or systemic corticosteroids at least 6 months before screening)

You may not qualify if:

• Incidence of asthma exacerbations per NAEPP ERP-3 within the last 3 months.
• Respiratory diseases other than asthma or allergic rhinitis.
• Uncontrolled asthma defined as having 3 - 4 of the following symptoms: a) Daytime asthma symptoms (\> twice/week) b) Night waking due to asthma c) Reliever needed for symptoms more than twice a week (excluding reliever taken before exercise) d) Any activity limitation due to asthma per GINA, Chapter 2, Box 2-2, page 29.
• Life threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s) within the previous 10 years.
• The known presence or history of tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex.
• The presence or history of clinically significant medical condition, other than asthma, including laboratory results abnormalities, that in the opinion of the investigator would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study. Following conditions should be considered carefully: congestive heart failure, recent myocardial infarction, uncontrolled hypertension, cardiac arrhythmias and diabetes mellitus, epilepsy, glaucoma, cataract, uncontrolled hypothyroidism, liver failure, severe osteoporosis, peptic ulceration and renal impairment.
• Hospitalization for asthma or a respiratory condition in the last 12 months.
• Need for oral steroids or/and antibiotics for lung disease in last the 3 months.
• Current or recent respiratory infection or current oral candida infection.
• Participation in another clinical trial or study within 1 month or at least 5 half-lives (whichever is longer) preceding the first dose of trial medication. Previous participation in this study.
• Use of any of the following excluded respiratory medications within the indicated time frame prior to screening and throughout the study:
• Anti-IgE antibody (e.g. Xolair) and depot corticosteroids 3 months
• Systemic (I.V., I.M., oral) corticosteroids 3 months
• Inhaled corticosteroids Stop at screening
• Long-acting anti-muscarinics (e.g., tiotropium) 48 hours

Sponsors & Collaborators

• Adamis Pharmaceuticals Corporation: lead

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Dennis Carlo

  CEO

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind double-dummy design for the test product and placebo for primary endpoint analysis. Evaluator blinded reference product
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: February 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: April 1, 2020
• Last Updated: July 17, 2019

Record last verified: 2019-07