AsthmaPhase 2ADENOASMANCT03774290
Study to Investigate the Effect of PBF-680 on Forced Expiratory Volume in 1 Second (FEV1) in Asthmatic Patients
A Phase 2 study testing PBF-680 in people with Asthma, run by Palobiofarma SL at 1 site in Spain.
Trial summary
The present trial is an exploratory study aiming at evaluating the safety, tolerability, and efficacy of a 15-day, once daily administration of 10 mg PBF-680 in subjects with persistent, mild-to-moderate atopic asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- PBF-680
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2018to 16 Mar 2020
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any study assessments are performed. Subjects must be able to communicate well with the investigator and staff so that they can understand and comply with the requirements of the study.
- Male and female subjects of 18-65 years age.
- Subjects with a medical history of mild-to-moderate persistent allergic asthma, diagnosed according to GINA 2017 guidelines, and managed in therapeutic steps 2-3 being inhaled corticosteroid (ICS) limited to low/medium dose, or step 4 restricted to medium-dose ICS plus ong-acting beta2-agonist (LABA) and/or a leukotriene antagonist, as maintenance therapy.
- A positive skin prick test to aeroallergens, such as house dust mite, tree or grass pollen, pet dander, or cockroach antigens. In addition, any allergens specific to the country/locality can be included.
- Women of child-bearing potential must agree to employ effective contraception from Visit 1 through FU visit, unless they are surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), are at least 2 years postmenopausal, or practice abstinence.
- All female subjects must have negative pregnancy test results at screening and baseline.
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- Male subjects must agree to use two acceptable methods of contraception, (e.g. spermicidal gel plus condom) for the entire duration of the study and up to the study completion visit, and refrain from fathering a child within the three months following the last study drug administration. Periodic abstinence and withdrawal are not acceptable methods of contraception.
- Subjects must weigh at least 45 kg and must have a body mass index (BMI) ≥ 17 kg/m2.
- Evidence of asthma as documented by either:
- Subjects must demonstrate an increase of ≥12% AND ≥200 mL in FEV1 over their pre- bronchodilator value within 30 min after inhaling a total of 400 μg of salbutamol (reversibility test). Reversibility can be documented prior to Screening (Visit 1) or determined at screening or during the weaning period up to visit V5.
- Or documented history of bronchial hyper reactivity (e.g. fall in FEV1 from baseline of more than or equal to 20 percent with inhaled standard doses of Adenosine monophosphate, methacholine or histamine, or more than or equal to 15 percent with standardized hyperventilation, hypertonic saline or mannitol challenge) from a bronchoprovocation study [e.g. methacholine challenge prior to Screening (Visit 1)].
- Or a decrease ≥ 5% of their initial FEV1 measured at V1 during the weaning period up to visit V5.
- Subjects must have either a pre-bronchodilator FEV1 ≥60% and ≤90% of their predicted normal value upon completion of LABA and ICS weaning on Visit 5 or a decrease ≥ 5% of their initial FEV1 measured at V1 during the weaning period up to visit V5.
- Subjects must have an ACQ-7 score ≥1.5 upon completion of LABA and ICS weaning on Visit 5.
- Subjects must meet a ≥80% compliance with the morning and evening electronic/PEF meter recordings during the weaning of their asthma maintenance therapy (i.e. from visit V2 to visit V5).
Who cannot join
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- History of hypersensitivity to the study medication or drugs of similar chemical classes (A1 adenosine receptor antagonists).
- A history of clinically significant ECG abnormalities or a recent history of autonomic dysfunction (e.g. recurrent episodes of fainting, arrhythmia, etc.).
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
- Pregnant or nursing (lactating) women.
- Smokers, defined by smoking within the previous 6 months or having a smoking history of more than 10 packs-years, a pack-year being defined as smoking the equivalent of 20 cigarettes (a pack) per day for 1 year.
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- Subjects with severe persistent asthma managed in GINA therapeutic step 4 (except for the restricted allowance in inclusion criterion 3) or 5 according to GINA 2017 guidelines. This criterion includes subjects treated with high-dose ICS, systemic corticosteroids, tiotropium bromide, theophylline or monoclonal antibody-based biological therapies such as omalizumab, mepolizumab, reslizumab, etc. Subjects treated with any immunosuppressant drug, or with systemic corticosteroids for any condition other than asthma, are excluded. Subjects requiring daily use of antihistamine drugs are also excluded.
- Present or past use of a biologic (e.g. monoclonal antibodies) agent for the treatment of asthma. Use of a biologic agent for any other condition within the past 6 months.
- Use of systemic corticosteroids to treat an asthma exacerbation or any other condition within 4 weeks prior to Visit 1.
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest and/or hypoxic seizures. History of asthma exacerbations that required ward hospitalization or an emergency room stay greater than 48 hours within 5 years prior to Visit 1.
- Any disease or illness other than asthma that may require the use of systemic corticosteroids during the study period.
- Any occupational exposure to allergens/irritants that may have a potential to worsen the asthma symptoms during the trial.
- A respiratory tract infection requiring the use of antibiotics within 4 weeks prior to visit V1, or pneumonia within 6 months prior to visit V1.
- An asthma exacerbation requiring treatment or the use of any health care resources within 4 weeks prior to visit V1. This includes asthma exacerbations managed with a transient increase of the subject's regular asthma maintenance therapy, and self- managed exacerbations using an "action plan".
- Subjects with any other underlying diseases that may compromise safety or may interfere with efficacy outcomes (e.g. tuberculosis, clinically relevant bronchiectasis, diffuse lung interstitial disease, pulmonary hypertension, emphysema, chronic bronchitis, alpha-1-antitrypsin deficiency, systemic immune-driven disorders).
- The use of prescription or over-the-counter medications is subjected to protocol- established restrictions (non-permitted medications)
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. The investigator must determine this in consideration of the subject's medical history and/or clinical or laboratory evidence of the following conditions, including but not limited to: inflammatory bowel disease; digestive tract ulcers; gastrointestinal or rectal bleeding; major gastrointestinal tract surgery such as gastrectomy or bowel resection; pancreatic injury or pancreatitis; liver disease or liver injury as indicated by abnormal liver function.
- Subjects that are receiving, or have received within the past 5 years, specific immunotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Double-blind, Randomized, Parallel-group, Placebo- Controlled Multi-center Study to Investigate the Effect of the Adenosine A1 Receptor Antagonist PBF-680 on Forced Expiratory Volume in 1 Second (FEV1) in Patients With Mild-to-moderate Persistent Atopic Asthma
The present trial is an exploratory study aiming at evaluating the safety, tolerability, and efficacy of a 15-day, once daily administration of 10 mg PBF-680 in subjects with persistent, mild-to-moderate atopic asthma.
Read the detailed description
Purpose and rationale: Extracellular adenosine, produced from dephosphorylation of adenosine triphosphate (ATP) and adenosine monophasphate (AMP), is an important signaling molecule in asthma, involved in bronchoconstriction and airway inflammation. PBF-680 is an A1 adenosine receptor antagonist that has successfully completed single dose escalation and treatment-period phase-I trials in healthy volunteers, plus a crossover, proof-of-concept Phase-IIa trial in mild and moderate asthmatics, where a single dose significantly attenuated airway hyperresponsiveness to AMP challenge and increased 8-hour post-challenge FEV1. In terms of exploratory efficacy, the primary purpose of this study is to determine whether PBF-680 compared to placebo, improves the FEV1, as well as to provide comparative safety data from this population of asthmatics. Measurements made in this study will also be used to establish whether this treatment improves other variables related to asthma control and lung function.
Objectives: The primary objective is to demonstrate an improvement in trough FEV1 upon a 15-day treatment with PBF-680 compared to placebo in mild-to-moderate asthmatics that, on study entry, are managed in Global Initiative for Asthma (GINA) therapeutic steps 2-3. Secondary objectives include determinations of FEV1 area under the curve (AUC), evaluations on pre- and post- bronchodilator FEV1, and patient reported outcomes (PROs) including Asthma Control Questionnaire-7 (ACQ-7) and Standardized Asthma Quality of Life Questionnaire (AQLQ(S)).
Study design and population: this is a multicenter, double-blind, randomized, placebo- controlled trial with a 2-arm parallel design. The treatments studied are once-daily PBF- 680 10 mg and placebo, as two orally administered, 5-mg PBF-680 capsules or two placebo capsules, respectively. The study comprises: (i) a minimum of 5-days screening period, during which, the subject's clinical stability and overall eligibility for the study will be assessed; (ii) a weaning phase where a stepwise tapering of the asthma medication will be done upon 7-day periods; (iii) the randomized, parallel-arm treatment period; and (iv) an end-of-study follow-up visit. The asthma medication weaning period comprises three possible visit pathways in order to adjust for each subject's asthma therapy on study entry. The study will comprise a primary analysis population of 58 stable asthmatic subjects managed as described for the objectives, who meet all inclusion criteria and no exclusion criteria and complete a full, valid data set for the primary variable. The total recruitment estimates to meet this target is 78 subjects.
- Conditions
- Asthma
- Being tested
- PBF-680, Placebo oral capsule
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBF-680Drug
PBF-680 is an adenosine A1 receptor antagonist
Placebo oral capsuleDrug
Oral gelatine capsule
| Study group | Role | What they receive |
|---|---|---|
| PBF-680 10 mg | Experimental | 10 mg of PBF-680 once a day Receives: Drug: PBF-680 |
| Placebo oral capsules | Placebo comparator | Placebo once a day Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of PBF-680 on trough forced expiratory volume in 1 second (FEV1)
Defined as the average of the FEV1 measurements taken at 23h 15min and 23h 45min post-dose after the final dose.
Measured: 16 Days
Secondary outcomes (8)
Effect of PBF-680 in the FEV1 area under curve AUC30min-23h 30min post-dose
Defined as the FEV1 area under curve of a serial of spirometries from 30min-23h 30min post-dose through days 15-to-16
Measured: 16 days
Effect of PBF-680 in the standardized FEV1 AUC30min-6h post- dose
Defined as the FEV1 area under curve of a serial of spirometries from 30min-6h post-dose on day 15
Measured: 15 Days
Effect of PBF-680 in the pre-bronchodilator FEV1
Defined as the FEV1 before use of bronchodilator at pre-dose spirometry on day 8
Measured: 8 days
Effect of PBF-680 in the post- bronchodilator FEV1 at pre-dose spirometry on day 8
Defined as the FEV1 after use of bronchodilator at pre-dose spirometry on day 8 and 16
Measured: Day 8 and Day 16
Effect of PBF-680 on the asthma control as measured by Asthma Questionnaires
Asthma Control Questionnaire (ACQ-7) comprises 5 patient-reported symptoms that are scored from 0 to 6.The points are added and divided by 5. According to the result:
Less than or equal to 0.75: Adequate control of asthma From 0.75 to 1.50: partially controlled asthma More than 1.50: Inadequate control of asthma. The Asthma Quality of Life Questionnaire AQLQ(S) scores symptoms, activity limitation, emotional function, and environmental exposure through 32 questions. The overall AQLQ score is the mean of the responses to each-of the 32 questions on a 7- point scale (7=no impairment, 1 =severe impairment)
Measured: Day 8 and Day 15
Effect of PBF-680 on daily, morning and evening FEV1 and PEF as measured by an electronic diary/Peak Expiratory Flow (PEF) meter device.
On each morning and evening, the subjects must fill the diary questions and record three brief expiratory maneuvers that generate PEF and FEV1 data.
Measured: 16 days
Effect of PBF-680 in the use of rescue bronchodilator as reported by the subject using an electronic diary/PEF meter device.
On each morning and evening, the subjects must fill the diary questions and record three brief expiratory maneuvers that generate PEF and FEV1 data
Measured: 16 days
Number of subjects with treatment-related adverse events as assessed by CTCAE v4
Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start1 Jun 2018
- Primary completion5 Feb 2020
- Study completion16 Mar 2020
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palobiofarma SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pivotal S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774290
- Sponsor's protocol ID
- PBF-680CT-05
- Acronym
- ADENOASMA
- Status last verified
- Sep 2020
- First submitted
- 11 Dec 2018
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Randomized, Parallel-group, Placebo- Controlled Multi-center Study to Investigate the Effect of the Adenosine A1 Receptor Antagonist PBF-680 on Forced Expiratory Volume in 1 Second (FEV1) in Patients With Mild-to-moderate Persistent Atopic Asthma
- ClinicalTrials.gov ID
- NCT03774290
- Acronym / sponsor ID
- ADENOASMA / PBF-680CT-05
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Palobiofarma SLIndustry (pharma, biotech, devices)
- Collaborators
- Pivotal S.L.
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 12 Dec 2018 (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.
The present trial is an exploratory study aiming at evaluating the safety, tolerability, and efficacy of a 15-day, once daily administration of 10 mg PBF-680 in subjects with persistent, mild-to-moderate atopic asthma.
Detailed description
Purpose and rationale: Extracellular adenosine, produced from dephosphorylation of adenosine triphosphate (ATP) and adenosine monophasphate (AMP), is an important signaling molecule in asthma, involved in bronchoconstriction and airway inflammation. PBF-680 is an A1 adenosine receptor antagonist that has successfully completed single dose escalation and treatment-period phase-I trials in healthy volunteers, plus a crossover, proof-of-concept Phase-IIa trial in mild and moderate asthmatics, where a single dose significantly attenuated airway hyperresponsiveness to AMP challenge and increased 8-hour post-challenge FEV1. In terms of exploratory efficacy, the primary purpose of this study is to determine whether PBF-680 compared to placebo, improves the FEV1, as well as to provide comparative safety data from this population of asthmatics. Measurements made in this study will also be used to establish whether this treatment improves other variables related to asthma control and lung function.
Objectives: The primary objective is to demonstrate an improvement in trough FEV1 upon a 15-day treatment with PBF-680 compared to placebo in mild-to-moderate asthmatics that, on study entry, are managed in Global Initiative for Asthma (GINA) therapeutic steps 2-3. Secondary objectives include determinations of FEV1 area under the curve (AUC), evaluations on pre- and post- bronchodilator FEV1, and patient reported outcomes (PROs) including Asthma Control Questionnaire-7 (ACQ-7) and Standardized Asthma Quality of Life Questionnaire (AQLQ(S)).
Study design and population: this is a multicenter, double-blind, randomized, placebo- controlled trial with a 2-arm parallel design. The treatments studied are once-daily PBF- 680 10 mg and placebo, as two orally administered, 5-mg PBF-680 capsules or two placebo capsules, respectively. The study comprises: (i) a minimum of 5-days screening period, during which, the subject's clinical stability and overall eligibility for the study will be assessed; (ii) a weaning phase where a stepwise tapering of the asthma medication will be done upon 7-day periods; (iii) the randomized, parallel-arm treatment period; and (iv) an end-of-study follow-up visit. The asthma medication weaning period comprises three possible visit pathways in order to adjust for each subject's asthma therapy on study entry. The study will comprise a primary analysis population of 58 stable asthmatic subjects managed as described for the objectives, who meet all inclusion criteria and no exclusion criteria and complete a full, valid data set for the primary variable. The total recruitment estimates to meet this target is 78 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBF-680 10 mg | Experimental | Drug: PBF-68010 mg of PBF-680 once a day |
| Placebo oral capsules | Placebo comparator | Drug: Placebo oral capsulePlacebo once a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent must be obtained before any study assessments are performed. Subjects must be able to communicate well with the investigator and staff so that they can understand and comply with the requirements of the study.
- Male and female subjects of 18-65 years age.
- Subjects with a medical history of mild-to-moderate persistent allergic asthma, diagnosed according to GINA 2017 guidelines, and managed in therapeutic steps 2-3 being inhaled corticosteroid (ICS) limited to low/medium dose, or step 4 restricted to medium-dose ICS plus ong-acting beta2-agonist (LABA) and/or a leukotriene antagonist, as maintenance therapy.
- A positive skin prick test to aeroallergens, such as house dust mite, tree or grass pollen, pet dander, or cockroach antigens. In addition, any allergens specific to the country/locality can be included.
- Women of child-bearing potential must agree to employ effective contraception from Visit 1 through FU visit, unless they are surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), are at least 2 years postmenopausal, or practice abstinence.
Key exclusion criteria (18 listed)
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- History of hypersensitivity to the study medication or drugs of similar chemical classes (A1 adenosine receptor antagonists).
- A history of clinically significant ECG abnormalities or a recent history of autonomic dysfunction (e.g. recurrent episodes of fainting, arrhythmia, etc.).
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
- Pregnant or nursing (lactating) women.
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 |
|---|---|---|
| PBF-680PBF-680 is an adenosine A1 receptor antagonist | Drug | PBF-680 10 mg |
| Placebo oral capsuleOral gelatine capsule | Drug | Placebo oral capsules |
Primary outcome
Effect of PBF-680 on trough forced expiratory volume in 1 second (FEV1)
Time frame: 16 Days
Defined as the average of the FEV1 measurements taken at 23h 15min and 23h 45min post-dose after the final dose.
8 secondary outcomes
Effect of PBF-680 in the FEV1 area under curve AUC30min-23h 30min post-dose
Time frame: 16 days
Effect of PBF-680 in the standardized FEV1 AUC30min-6h post- dose
Time frame: 15 Days
Effect of PBF-680 in the pre-bronchodilator FEV1
Time frame: 8 days
Effect of PBF-680 in the post- bronchodilator FEV1 at pre-dose spirometry on day 8
Time frame: Day 8 and Day 16
Effect of PBF-680 on the asthma control as measured by Asthma Questionnaires
Time frame: Day 8 and Day 15
Effect of PBF-680 on daily, morning and evening FEV1 and PEF as measured by an electronic diary/Peak Expiratory Flow (PEF) meter device.
Time frame: 16 days
Effect of PBF-680 in the use of rescue bronchodilator as reported by the subject using an electronic diary/PEF meter device.
Time frame: 16 days
Number of subjects with treatment-related adverse events as assessed by CTCAE v4
Time frame: 16 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PBF-680 in people with Asthma, run by Palobiofarma SL at 1 site in Spain.
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 15 inclusion and 18 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: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of PBF-680 on trough forced expiratory volume in 1 second (FEV1) (time frame: 16 Days). 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 25 Sep 2020.