AsthmaPhase 2NCT02635945
A Study to Assess the Efficacy of a 5-day, 10- mg PBF-680 Oral Administration on Late Asthmatic Responses (LAR) in Mild to Moderate Asthmatic Patients.
A Phase 2 study testing PBF-680 in people with Asthma, run by Palobiofarma SL at 1 site in Spain.
Trial summary
This study is the second Phase-II trial analyzing efficacy outcomes of PBF-680 in asthmatic subjects, following the supportive data from the proof-of-concept trial on the effect of PBF-680 on airway hyperresponsiveness to adenosine monophasphate (AMP). Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 8 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to 30 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults aged ³18, who have signed the informed consent form prior to initiation of any study procedures.
- Subjects who have controlled asthma, diagnosed and determined as such as per the Global Initiative for Asthma (GINA) guidelines, with low-to-medium dose inhaled corticosteroid (ICS) as maintenance monotherapy and inhaled, short-acting β2-agonist bronchodilator as rescue medication, for a minimum 4-week period before screening visit V1. Controlled asthma under the stated therapy can be the current, stable condition presented at visits V0 and V1 or can be achieved through GINA guideline-based clinical practice through one or more discretionary V0b visits.
- Subjects must have a body mass index between 18 and 35 kg/m².
- Subjects must be able to perform acceptable spirometry in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for acceptability and repeatability.
Who cannot join
- Current smokers, smokers within six months prior to Visit V1, or subjects with an smoking history greater than 10 packs-years.
- Asthmatics classed as "intermittent asthma" managed in GINA-1 therapeutic step or asthmatics that need any maintenance controller medication beyond low-to-medium inhaled corticosteroid (ICS).
- Patients under any immunosuppressive medication whether asthma-related or indicated for any concomitant morbidities.
- Subjects with a history of life-threatening asthma attacks (i.e. requiring intensive care unit (ICU) admission, orotracheal intubation).
- Subjects with a history of a respiratory tract infection or an asthma exacerbation requiring the use of antibiotics and/or systemic corticosteroids within 4 weeks prior to visit V1, or who develop a respiratory tract infection or asthma exacerbation during the screening period. In the latter case, the subjects can be re-screened 4 weeks after the last dose of systemic corticosteroid (except for depot corticosteroids; see Table 5.5-1) or antibiotic.
- Subjects that received bronchial thermoplasty treatment.
Show all 20Show fewer
- Subjects with a concomitant pulmonary or thoracic disease other than asthma that may compromise safety or interfere with efficacy outcomes as per site investigator assessment. This includes, but is not limited to, COPD (COPD) attributable to tobacco or α1- antitrypsin deficiency, cystic fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, active pulmonary tuberculosis, or any prior condition that led to pulmonary resection surgery or lung transplantation. Non-cystic fibrosis bronchiectasis without clinically significant morbidity, moderate α1-antitrypsin deficiency without evidence of emphysema or related COPD, or past pulmonary tuberculosis that received proper medical treatment, are acceptable provided that the condition is not expected to interfere with pulmonary function testing as per site investigator assessment.
- Subjects with any skin condition such as dermographism that may prevent correct interpretation of skin prick allergy tests.
- Subjects with symptoms of angina pectoris or with a history of confirmed coronary disease or cardiomyopathy.
- Subjects with A-V block in any degree, sinus bradycardia, tachyarrhythmia, unstable atrial fibrillation, long QT syndrome, corrected QT interval (QTc(F)) interval greater than 450 ms at screening EKG on visit V1, or any other EKG abnormality deemed clinically significant by the investigator.
- Subjects who have a clinically significant laboratory abnormality at screening blood analysis on visit V2+24h.
- Subjects with current uncontrolled arterial hypertension.
- Women of child-bearing potential, unless they are surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), are at least 2 years postmenopausal, practice abstinence, or agree to employ effective contraception from Visit 1 through final visit. Acceptable contraception procedures are oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, or use of a condom with spermicide by the sexual partner.
- Women supplying lactation.
- Receipt of any investigational drug or biological therapy within 3 months before randomization in this study, or within 5 half-lives of the investigational agent, whichever is longer. Subjects ever treated with omalizumab or other biological therapies for asthma are not eligible.
- History of any known immunodeficiency disorder.
- Subjects with a history of malignancy within the past five years, with the exception of localized basal cell carcinoma of the skin.
- History of treatment for alcohol or drug abuse within the past year.
- Subjects with any comorbidity that could affect the safety or efficacy as per site investigator assessment.
- Subjects not meeting other medication restrictions as stated in Table 5.5-1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Efficacy of a 5-day, Once Daily 10- mg PBF-680 Oral Administration Course to Attenuate Allergen Bronchoprovocation-induced Late Asthmatic Responses (LAR) in Asthmatic Patients Controlled on Low-to-medium Dose Inhaled Corticosteroid Maintenance Monotherapy and Inhaled Short Acting Beta-2 Agonist as Rescue Bronchodilator
This study is the second Phase-II trial analyzing efficacy outcomes of PBF-680 in asthmatic subjects, following the supportive data from the proof-of-concept trial on the effect of PBF-680 on airway hyperresponsiveness to adenosine monophasphate (AMP). The purpose of the present study is to provide an assessment on the efficacy of a 5-day treatment course of once daily, orally administered, 10-mg PBF-680 doses, to attenuate "Late Asthmatic Responses" (LAR) as a primary efficacy outcome. The study also aims at analyzing the effect of the PBF-680 treatment course on airway inflammation-related outcomes including airway hyperresponsiveness to AMP at 24 h after allergen bronchoprovocation, plus nitric oxide fraction in exhaled air (FeNO) and airway inflammatory cells counts in induced sputum under the effect of an additional 10-mg PBF-680 dose on the 6th treatment period day. Overall, the study aims at providing evidence on the efficacy of PBF-680 on outcomes, particularly the LAR, that are well established to screen valid drugs for asthma maintenance therapy.
- Conditions
- Asthma
- Being tested
- PBF-680, Placebo
- Keywords
- adenosine A1 receptor antagonist, adenosine receptor modulator, COPD, asthma
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBF-680Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PBF-680 10 mg | Experimental | 2 capsules: PBF-680, 5 mg capsules for oral administration (excipient: 76 mg microcrystalline cellulose). Receives: Drug: PBF-680 |
| Placebo | Placebo comparator | 2 capsules: Placebo to PBF-680, as 95.12 mg microcrystalline cellulose capsules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Asthmatic Response (LAR) , measured as the fall of the forced expiratory volume (FEV1) between 3 and 10 hours postallergen bronchoprovocation
Measured: 3-to-10 hour post-allergen bronchoprovocation.
Secondary outcomes (10)
Early Asthmatic Response (EAR), measured as the maximum FEV1 fall from the postdiluent value
Measured: within 1 hour post-allergen bronchoprovocation.
hyperresponsiveness to AMP in terms of provocative concentration causing a 20% fall (PC20) increment in response to AMP airway challenge
Measured: 24-hour post-allergen bronchoprovocation
Nitric oxide fraction in exhaled air (FeNO) on post-allergen bronchoprovocation day
Measured: 6th treatment period day
Total leukocytes per mL in induced sputum on post-allergen bronchoprovocation day
Measured: 6th treatment period day
Leukocyte differential counts per mL in induced sputum on post-allergen bronchoprovocation day.
Leukocyte subpopulations from cytocentrifuged, stained preparations will be counted and expressed as percentage cell numbers per volume unit.
Measured: 6th treatment period day
Adverse events
The occurrence of adverse events will be monitored through the complete study. Adverse events will be recorded with the following information: severity grade (mild, moderate, severe); suspected/unsuspected relationship to the study drug; duration (date and time of onset, defined as precisely as possible, and end date or if continuing at final exam)
Measured: 2 Months
Vital signs
Vital signs will include radial artery pulse rate (measured for 60 seconds), and systolic and diastolic blood pressure. Pulse rate and blood pressure will be assessed in the right arm after the patient has rested in the sitting position for at least 5 min. Vital sign values will be recorded as notable if: pulse rate <40 or >90 bpm; systolic blood pressure <90 or >140 mmHg; diastolic blood pressure <50 or >90 mmHg.
Measured: 9 times during 2 months
Number of Participants With Abnormal Laboratory Values
On visits V2+24h, V4+24h and V6+24h, venipuncture will be performed for blood laboratory evaluations. The analysis will be performed at the local laboratory, and will include: hemogram with complete blood counts and differential leukocyte counts; clinical biochemistry including electrolytes (sodium, potassium, chloride), glucose, creatinine, urea, aspartate transaminase (AST), alanine transaminase (ALT), gammaglutamyl transpeptidase (GGT) and bilirubin; and serum immunoglobulin E (IgE) (only on visit V2+24h).
Measured: 4 times during 2 months
Physical examination
Measured: 7 times during 2 months
Electrocardiogram (EKG)
Measured: 3 times during 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startApr 2016
- Primary completion30 Sep 2019
- Study completion30 Nov 2019
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palobiofarma SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital de Sant Pau
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635945
- Sponsor's protocol ID
- IIBSP-PBF-2015-34
- Other IDs
- 2015-001957-34, 2015
- Status last verified
- Jun 2020
- First submitted
- 21 Oct 2015
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Efficacy of a 5-day, Once Daily 10- mg PBF-680 Oral Administration Course to Attenuate Allergen Bronchoprovocation-induced Late Asthmatic Responses (LAR) in Asthmatic Patients Controlled on Low-to-medium Dose Inhaled Corticosteroid Maintenance Monotherapy and Inhaled Short Acting Beta-2 Agonist as Rescue Bronchodilator
- ClinicalTrials.gov ID
- NCT02635945
- Acronym / sponsor ID
- IIBSP-PBF-2015-34
- Conditions
- Asthma
- Keywords
- adenosine A1 receptor antagonist, adenosine receptor modulator, COPD, asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Palobiofarma SLIndustry (pharma, biotech, devices)
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital de Sant Pau
- Study start
- Apr 2016 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 21 Dec 2015 (estimated)
- 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.
This study is the second Phase-II trial analyzing efficacy outcomes of PBF-680 in asthmatic subjects, following the supportive data from the proof-of-concept trial on the effect of PBF-680 on airway hyperresponsiveness to adenosine monophasphate (AMP). The purpose of the present study is to provide an assessment on the efficacy of a 5-day treatment course of once daily, orally administered, 10-mg PBF-680 doses, to attenuate "Late Asthmatic Responses" (LAR) as a primary efficacy outcome. The study also aims at analyzing the effect of the PBF-680 treatment course on airway inflammation-related outcomes including airway hyperresponsiveness to AMP at 24 h after allergen bronchoprovocation, plus nitric oxide fraction in exhaled air (FeNO) and airway inflammatory cells counts in induced sputum under the effect of an additional 10-mg PBF-680 dose on the 6th treatment period day. Overall, the study aims at providing evidence on the efficacy of PBF-680 on outcomes, particularly the LAR, that are well established to screen valid drugs for asthma maintenance therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBF-680 10 mg | Experimental | Drug: PBF-6802 capsules: PBF-680, 5 mg capsules for oral administration (excipient: 76 mg microcrystalline cellulose). |
| Placebo | Placebo comparator | Drug: Placebo2 capsules: Placebo to PBF-680, as 95.12 mg microcrystalline cellulose capsules. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female adults aged ³18, who have signed the informed consent form prior to initiation of any study procedures.
- Subjects who have controlled asthma, diagnosed and determined as such as per the Global Initiative for Asthma (GINA) guidelines, with low-to-medium dose inhaled corticosteroid (ICS) as maintenance monotherapy and inhaled, short-acting β2-agonist bronchodilator as rescue medication, for a minimum 4-week period before screening visit V1. Controlled asthma under the stated therapy can be the current, stable condition presented at visits V0 and V1 or can be achieved through GINA guideline-based clinical practice through one or more discretionary V0b visits.
- Subjects must have a body mass index between 18 and 35 kg/m².
- Subjects must be able to perform acceptable spirometry in accordance with American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria for acceptability and repeatability.
Key exclusion criteria (20 listed)
- Current smokers, smokers within six months prior to Visit V1, or subjects with an smoking history greater than 10 packs-years.
- Asthmatics classed as "intermittent asthma" managed in GINA-1 therapeutic step or asthmatics that need any maintenance controller medication beyond low-to-medium inhaled corticosteroid (ICS).
- Patients under any immunosuppressive medication whether asthma-related or indicated for any concomitant morbidities.
- Subjects with a history of life-threatening asthma attacks (i.e. requiring intensive care unit (ICU) admission, orotracheal intubation).
- Subjects with a history of a respiratory tract infection or an asthma exacerbation requiring the use of antibiotics and/or systemic corticosteroids within 4 weeks prior to visit V1, or who develop a respiratory tract infection or asthma exacerbation during the screening period. In the latter case, the subjects can be re-screened 4 weeks after the last dose of systemic corticosteroid (except for depot corticosteroids; see Table 5.5-1) or antibiotic.
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-680 | Drug | PBF-680 10 mg |
| Placebo | Drug | Placebo |
Primary outcome
Late Asthmatic Response (LAR) , measured as the fall of the forced expiratory volume (FEV1) between 3 and 10 hours postallergen bronchoprovocation
Time frame: 3-to-10 hour post-allergen bronchoprovocation.
10 secondary outcomes
Early Asthmatic Response (EAR), measured as the maximum FEV1 fall from the postdiluent value
Time frame: within 1 hour post-allergen bronchoprovocation.
hyperresponsiveness to AMP in terms of provocative concentration causing a 20% fall (PC20) increment in response to AMP airway challenge
Time frame: 24-hour post-allergen bronchoprovocation
Nitric oxide fraction in exhaled air (FeNO) on post-allergen bronchoprovocation day
Time frame: 6th treatment period day
Total leukocytes per mL in induced sputum on post-allergen bronchoprovocation day
Time frame: 6th treatment period day
Leukocyte differential counts per mL in induced sputum on post-allergen bronchoprovocation day.
Time frame: 6th treatment period day
Adverse events
Time frame: 2 Months
Vital signs
Time frame: 9 times during 2 months
Number of Participants With Abnormal Laboratory Values
Time frame: 4 times during 2 months
Physical examination
Time frame: 7 times during 2 months
Electrocardiogram (EKG)
Time frame: 3 times during 2 months
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 30 Jun 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 4 inclusion and 20 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 30 Jun 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?
Late Asthmatic Response (LAR) , measured as the fall of the forced expiratory volume (FEV1) between 3 and 10 hours postallergen bronchoprovocation (time frame: 3-to-10 hour post-allergen bronchoprovocation.). 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 30 Jun 2020.