AsthmaPhase 3NCT03834012
Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Persistent Asthma
A Phase 3 study testing Beclomethasone 800 µg per day, Beclomethasone 400 µg per day and Beclomethasone 640 µg per day in people with Asthma, run by Adamis Pharmaceuticals Corporation.
Trial summary
Approximately 480 (120 per group) would need to complete the 6 weeks of treatments. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Beclomethasone 800 µg per day, Beclomethasone 400 µg per day and Beclomethasone 640 µg per day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 47Show fewer
- 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 Exclusion criteria
- 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
- Short-acting anti-muscarinics (e.g., ipratropium) 24 hours
- LABA (e.g., salmeterol, formoterol,etc.) 12 hours
- Short-acting β2-adrenergic agonists (SABA), except for study rescue medication (albuterol) (see Section 4.7) 6 hours
- Oral β2-adrenergic agonists 1 month
- Topical dermatologic corticosteroids of intermediate to high potency such as fluticasone propionate, mometasone furoate 14 days
- Oral or nasal antihistamines unless on a stable dose for 30 days prior screening.
- Immunologically active biologic medications such as anti-TNFα (tumor necrosis factor) 3 months
- Immunosuppressive therapy such as methotrexate, gold, Azathioprine 1 month
- Immunotherapy initiation within 3 months or change in dose within 1 month
- Over-the-counter bronchodilators 2 weeks
- Marijuana 1 month
- Inhaled nicotine such as e-cigarettes 1 day
- Use of the following medications 30 days before screening:
- Non-cardioselective β-blockers (e.g. propranolol, nadolol, carvedilol, labetalol, sotalol) o. Digitalis p. Thiazide diuretics q. Oral decongestants r. Potent Cytochrome P450 3A4 enzyme inhibitors s. Benzodiazepines t. Cyclic antidepressants u. Monoamine oxidase inhibitors v. Diazoxide w. Ketoconazole, itraconazole x. Phenytoin y. Rifampicin z. Mifepristone
- Known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
- Evidence (as assessed by the Investigator using good clinical judgment) of alcohol or drug abuse or dependency at the time of screening, for the 6 months prior to screening.
- Donation or loss of blood or plasma of one unit (about 450 mL whole blood or 220 mL plasma) in the previous 60 days. (Applicable for patients participating in PK arm of the study).
- Lived in the same household as currently enrolled subject.
- Any other reason which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Who cannot join
None listed.
About this study
Official title: A Randomized, Parallel Group, Placebo-controlled, Multicenter Phase 3 Study With a PK Sub-group Study With Beclomethasone HFA at 400 μg and 800 μg Daily Doses Compared to Placebo and QVAR in Persistent Asthma.
Approximately 480 (120 per group) would need to complete the 6 weeks of treatments.
Read the detailed description
This is four arm study. Approximately 480 (120 per group) would need to complete the 6 weeks of treatments.
In order to achieve that number of subjects, approximately 700 subjects will be screened randomized into the study.
A screening visit (Visit 1) will be inclusive of at least the 2-week (14 days) placebo Run-in Period during which asthma subjects will wash out their daily inhaled corticosteroid and other medications and assessed for compliance. Study treatment period will be for a duration of 6 weeks with visits: Visit 2 - Baseline Day 1; Visit 3 Day 21 (± 2 days) and Visit 4 Day 42 (± 2 days). Rescue Therapy: Short-acting beta agonists, Albuterol 90 μg/actuation
- Conditions
- Asthma
- Being tested
- Beclomethasone 800 µg per day, Placebo, Beclomethasone 400 µg per day, Beclomethasone 640 µg per day
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclomethasone 800 µg per dayDrug
Also called Beclomethasone Dipropionate HFA
Intervention: Drug: Beclomethasone 800 µg HFA per day
PlaceboDrug
Also called Placebo for Beclomethasone Dipropionate HFA
Intervention: Drug: placebo
Beclomethasone 400 µg per dayDrug
Also called Beclomethasone Dipropionate HFA
Intervention: Drug: Beclomethasone 400 µg HFA per day
Beclomethasone 640 µg per dayDrug
Also called QVAR
Intervention: Drug: Beclomethasone 640 µg per day
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Beclomethasone 640 µg per day |
| Placebo | Placebo comparator | Intervention: Drug: placebo 4 inhalations 2 times a day for 6 weeks Receives: 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 Receives: Drug: Placebo; Drug: Beclomethasone 400 µg per day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
AUC at week in FEV1 compared to placebo
Continuous secondary efficacy endpoints and other continuous tertiary efficacy endpoints will be analyzed similarly to that specified for the primary endpoint. After FEV1%-predicted is estimated for all scheduled visits (either as observed or as imputed for missing), AUC0-6 FEV1 percent predicted (0-6 weeks) will be calculated and Satterhwaite t-test will be used to compare the difference on AUC0-6 between treatment groups and placebo.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study startFeb 2019 (estimated)
- Primary completionNov 2019 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adamis Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Carlo, Study chair, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834012
- Sponsor's protocol ID
- APC-1000-02
- Status last verified
- Jul 2019
- First submitted
- 6 Feb 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Group, Placebo-controlled, Multicenter Phase 3 Study With a PK Sub-group Study With Beclomethasone HFA at 400 μg and 800 μg Daily Doses Compared to Placebo and QVAR in Persistent Asthma.
- ClinicalTrials.gov ID
- NCT03834012
- Acronym / sponsor ID
- APC-1000-02
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Adamis Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2019 (estimated)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 480 (120 per group) would need to complete the 6 weeks of treatments.
Detailed description
This is four arm study. Approximately 480 (120 per group) would need to complete the 6 weeks of treatments.
In order to achieve that number of subjects, approximately 700 subjects will be screened randomized into the study.
A screening visit (Visit 1) will be inclusive of at least the 2-week (14 days) placebo Run-in Period during which asthma subjects will wash out their daily inhaled corticosteroid and other medications and assessed for compliance. Study treatment period will be for a duration of 6 weeks with visits: Visit 2 - Baseline Day 1; Visit 3 Day 21 (± 2 days) and Visit 4 Day 42 (± 2 days). Rescue Therapy: Short-acting beta agonists, Albuterol 90 μg/actuation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beclomethasone 800 µg per day | Experimental | Drug: Beclomethasone 800 µg per dayIntervention: 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 |
| Beclomethasone 640 µg per day | Active comparator | Drug: Beclomethasone 640 µg per dayIntervention: Drug: Beclomethasone 640 µg per day 4 inhalations 80 μg ex-actuator 2 times a day for 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboIntervention: Drug: placebo 4 inhalations 2 times a day for 6 weeks |
| Beclomethasone 400 µg per day | Experimental | Drug: Placebo, Drug: Beclomethasone 400 µg per dayIntervention: 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 |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (47 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beclomethasone 800 µg per dayAlso: Beclomethasone Dipropionate HFAIntervention: Drug: Beclomethasone 800 µg HFA per day | Drug | Beclomethasone 800 µg per day |
| PlaceboAlso: Placebo for Beclomethasone Dipropionate HFAIntervention: Drug: placebo | Drug | Beclomethasone 400 µg per day, Placebo |
| Beclomethasone 400 µg per dayAlso: Beclomethasone Dipropionate HFAIntervention: Drug: Beclomethasone 400 µg HFA per day | Drug | Beclomethasone 400 µg per day |
| Beclomethasone 640 µg per dayAlso: QVARIntervention: Drug: Beclomethasone 640 µg per day | Drug | Beclomethasone 640 µg per day |
Primary outcome
Change from baseline in FEV1 percent predicted compared to placebo
Time frame: 6 weeks
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.
1 secondary outcome
AUC at week in FEV1 compared to placebo
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Carlo study chair
CEO
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Beclomethasone 800 µg per day, Beclomethasone 400 µg per day and Beclomethasone 640 µg per day in people with Asthma, run by Adamis Pharmaceuticals Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 47 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in FEV1 percent predicted compared to placebo (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.