Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Mild to Moderate Persistent Asthma

NCT03835871 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: APC-1000-03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Approximately 480 (120 per group) would need to complete the 12 weeks of treatments.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Mean Change from baseline trough (pre-dose and pre-rescue) FEV1 percent predicted at week 12

  Mean Change from baseline trough (pre-dose and pre-rescue) FEV1 percent predicted at week 12

  12 weeks

Study Arms (4)

400 µg per day Beclomethasone

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 12 weeks

Drug: 400 µg per day Beclomethasone

200 µg per day Beclomethasone

EXPERIMENTAL

Intervention: Drug: Beclomethasone 200 µg per day Daily dose of Beclomethasone 200 µg 1 inhalation 100 μg ex-valve 2 times a day for 12 weeks Intervention: Drug: Placebo 1 inhalation 2 times a day for 12 weeks

Drug: Placebo; Drug: 200 µg per day Beclomethasone

100 µg per day Beclomethasone

EXPERIMENTAL

Intervention: Drug: Beclomethasone 100 µg per day Daily dose of Beclomethasone 100 µg 1 inhalation 50 μg ex-valve 2 times a day for 12 weeks Intervention: Drug: Placebo 1 inhalation 2 times a day for 12 weeks

Drug: Placebo; Drug: 100 µg per day Beclomethasone

placebo

PLACEBO COMPARATOR

Intervention: Drug: placebo 2 inhalations 2 times a day for 12 weeks

Drug: Placebo

Interventions

Placebo DRUG

Intervention: Drug: placebo

Also known as: placebo for Beclomethasone Dipropionate HFA

100 µg per day Beclomethasone; 200 µg per day Beclomethasone; placebo

400 µg per day Beclomethasone DRUG

Intervention: Drug: Beclomethasone 400 µg HFA per day

Also known as: Beclomethasone Dipropionate HFA

400 µg per day Beclomethasone

200 µg per day Beclomethasone DRUG

Intervention: Drug: Beclomethasone 200 µg HFA per day

Also known as: Beclomethasone Dipropionate HFA

200 µg per day Beclomethasone

100 µg per day Beclomethasone DRUG

Intervention: Drug: Beclomethasone 100 µg HFA per day

Also known as: Beclomethasone Dipropionate HFA

100 µg per day Beclomethasone

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 mild to moderate asthma as defined by the National Asthma Education a Prevention Program (NAEPP ERP-3 ), 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 \> 60% of the predicted value of predicted values 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 in on inhaled corticosteroids the subject must be on a stable dose of daily-inhaled corticosteroid (ICS), at least 80 μg/day of beclomethasone dipropionate or equivalent for a minimum of 4 weeks before screening visit
• 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)
• Prior corticosteroid users

You may not qualify if:

• Incidence of asthma exacerbations per NAEPP ERP-3(1) (Appendix IV) 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 a clinically significant medical condition, other than asthma including laboratory result 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 infraction, 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 and/or antibiotics for lung disease in last 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: February 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: May 1, 2020
• Last Updated: July 17, 2019

Record last verified: 2019-07