AsthmaPhase 2NCT01939587
Study to Assess the Efficacy of a Single PBF-680 Oral Administration to Attenuate Adenosine 5'-Monophosphate Challenge-induced Airway Hyperresponsiveness in Mild-to-moderate Asthmatics
A Phase 2 study testing PBF-680 5 mg and PBF-680 20 mg in people with Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites in Spain.
Trial summary
This is a single-center, double-blind, randomized trial utilizing a three-period, balanced block design, with each period comprising a unique study product administration. The treatments studied are PBF-680 5 mg, PBF-680 20 mg and placebo, as an orally administered capsule. 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 5 mg and PBF-680 20 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesSpain
- Study dates
- Dec 2013to Jul 2014
- 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 18, who have signed the informed consent form prior to initiation of any study procedures.
- Subjects with mild to moderate asthma, diagnosed as per Global Initiative for Asthma(GINA) guidelines.
- Subjects must have a body mass index between 18 and 35 kg/m².
- Subjects must be able to perform acceptable spirometry in accordance with ATS/ERS criteria for acceptability repeatability.
- Subjects must have a baseline FEV1 60% of predicted normal, and greater than 1 L in absolute value, on Visit 2.
- On Visit 2, eligible subjects must show airway hyperresponsiveness to AMP, determined by PC20 thresholding (the AMP provocative concentration that elicits a 20% drop from baseline FEV1 value, under AMP challenge test as per the ERS Task Force on Indirect Airway Challenges).
Who cannot join
- Current smokers, smokers within six months prior to Visit 1, or subjects with an smoking history greater than 5 pack-years.
- Asthmatics in treatment Step 5 as per GINA guidelines, including oral corticosteroids and/or omalizumab, or any immunosuppressive medication whether asthma-related or indicated for any concomitant morbidities.
- Subjects with a history of life-threatening asthma attacks (i.e. requiring ICU admission, orotracheal intubation).
- Subjects with a history of a respiratory tract infection or an asthma crisis requiring the use of antibiotics and/or systemic corticosteroids within 4 weeks prior to Visit 1, or who develop a respiratory tract infection or asthma crisis during the screening period. In the latter case, the subjects can be re-screened four weeks after the last dose of systemic corticosteroid or antibiotic.
- Subjects that received bronchial thermoplastic treatment.
- Subjects with concomitant pulmonary or thoracic disease other than asthma that could interfere safety or efficacy as per site investigator assessment. This includes, but is not limited to, COPD attributable to tobacco or alpha-1 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 alpha-1 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.
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- 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, QTc(F) interval greater than 450 ms at screening(Visit 2), or any other EKG abnormality deemed clinically significant by the investigator.
- Subjects who have a clinically significant laboratory abnormality at screening (Visit 2).
- 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 Visit 6. 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 therapy or biologicals within 3 months before randomization in this study, or within 5 half-lives of the investigational agent or biologic, whichever is longer.
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Palobiofarma S.L. (molecule owner)
Mataró, Barcelona, 08302
About this study
Official title: A Single-centre, Randomised, Double-blind, Placebo-controlled, 3-way Multiple Dose, Cross-over, "Proof-of-concept" Study to Assess the Efficacy of a Single PBF-680 Oral Administration to Attenuate Adenosine 5'-Monophosphate (AMP) Challenge-induced Airway Hyperresponsiveness in Mild-to-moderate Asthmatics
This is a single-center, double-blind, randomized trial utilizing a three-period, balanced block design, with each period comprising a unique study product administration. The treatments studied are PBF-680 5 mg, PBF-680 20 mg and placebo, as an orally administered capsule. The study includes a screening visit, a selection visit, three visits for the randomized treatment sequence, and an end-of-study follow-up visit, spanning through a 65-day maximum study duration. The study will be conducted on 18 male or female adults aged ³18 years, with a diagnosis of stable, mild to moderate asthma as per GINA guidelines, with no smoking or less than a 5 packs-years smoking history history, responsive to AMP airway challenge as determined in the selection visit.
The primary efficacy variable will be the PC20 yielded from AMP airway challenge testing at the three treatment visits. FeNO, sampled at three time points at each treatment period visit, will be a exploratory variable. Safety assessment will include monitoring of adverse events, physical examination, vital signs, EKGs, spirometry, serum and urine pregnancy tests, and laboratory determinations. Blood sampling at a time-point series will provide pharmacokinetics data.
The primary variable of the study is PC20, mg×mL-1. The PC 20 distributions will be analyzed by treatment using ANOVA for repeated measurements, followed by post hoc pairwise comparisons as appropriate. Other analyses will comprise FeNO, pharmacokinetics, data sets generated from baseline characteristics and safety assessments, and discretionary expiratory analyses to evaluate the influence of baseline and clinical covariates on the primary variable.
- Conditions
- Asthma
- Being tested
- PBF-680 5 mg, PBF-680 20 mg, Placebo
- Keywords
- Adenosine A1 receptor antagonist, Asthma, adenosine receptor modulator, COPD
- 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-680 5 mgDrug
PBF-680 20 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| PBF-680 5 mg | Experimental | 5 mg of PBF-680 Receives: Drug: PBF-680 5 mg |
| PBF-680 20 mg | Experimental | 20 mg of PBF-680 Receives: Drug: PBF-680 20 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PC20 yielded from AMP airway challenge testing
Measured: 2.25, 3.5, 8 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startDec 2013
- Primary completionJul 2014
- Study completionJul 2014
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.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Palo Biofarma, S.L
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939587
- Sponsor's protocol ID
- IIBSP-PBF-2013-93
- Other IDs
- 2013-002906-30
- Status last verified
- Mar 2016
- First submitted
- 8 Aug 2013
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Double-blind, Placebo-controlled, 3-way Multiple Dose, Cross-over, "Proof-of-concept" Study to Assess the Efficacy of a Single PBF-680 Oral Administration to Attenuate Adenosine 5'-Monophosphate (AMP) Challenge-induced Airway Hyperresponsiveness in Mild-to-moderate Asthmatics
- ClinicalTrials.gov ID
- NCT01939587
- Acronym / sponsor ID
- IIBSP-PBF-2013-93
- Conditions
- Asthma
- Keywords
- Adenosine A1 receptor antagonist, Asthma, adenosine receptor modulator, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Palo Biofarma, S.L
- Study start
- Dec 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Sep 2013 (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 is a single-center, double-blind, randomized trial utilizing a three-period, balanced block design, with each period comprising a unique study product administration. The treatments studied are PBF-680 5 mg, PBF-680 20 mg and placebo, as an orally administered capsule. The study includes a screening visit, a selection visit, three visits for the randomized treatment sequence, and an end-of-study follow-up visit, spanning through a 65-day maximum study duration. The study will be conducted on 18 male or female adults aged ³18 years, with a diagnosis of stable, mild to moderate asthma as per GINA guidelines, with no smoking or less than a 5 packs-years smoking history history, responsive to AMP airway challenge as determined in the selection visit.
The primary efficacy variable will be the PC20 yielded from AMP airway challenge testing at the three treatment visits. FeNO, sampled at three time points at each treatment period visit, will be a exploratory variable. Safety assessment will include monitoring of adverse events, physical examination, vital signs, EKGs, spirometry, serum and urine pregnancy tests, and laboratory determinations. Blood sampling at a time-point series will provide pharmacokinetics data.
The primary variable of the study is PC20, mg×mL-1. The PC 20 distributions will be analyzed by treatment using ANOVA for repeated measurements, followed by post hoc pairwise comparisons as appropriate. Other analyses will comprise FeNO, pharmacokinetics, data sets generated from baseline characteristics and safety assessments, and discretionary expiratory analyses to evaluate the influence of baseline and clinical covariates on the primary variable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PBF-680 5 mg | Experimental | Drug: PBF-680 5 mg5 mg of PBF-680 |
| PBF-680 20 mg | Experimental | Drug: PBF-680 20 mg20 mg of PBF-680 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female adults aged 18, who have signed the informed consent form prior to initiation of any study procedures.
- Subjects with mild to moderate asthma, diagnosed as per Global Initiative for Asthma(GINA) guidelines.
- Subjects must have a body mass index between 18 and 35 kg/m².
- Subjects must be able to perform acceptable spirometry in accordance with ATS/ERS criteria for acceptability repeatability.
- Subjects must have a baseline FEV1 60% of predicted normal, and greater than 1 L in absolute value, on Visit 2.
Key exclusion criteria (17 listed)
- Current smokers, smokers within six months prior to Visit 1, or subjects with an smoking history greater than 5 pack-years.
- Asthmatics in treatment Step 5 as per GINA guidelines, including oral corticosteroids and/or omalizumab, or any immunosuppressive medication whether asthma-related or indicated for any concomitant morbidities.
- Subjects with a history of life-threatening asthma attacks (i.e. requiring ICU admission, orotracheal intubation).
- Subjects with a history of a respiratory tract infection or an asthma crisis requiring the use of antibiotics and/or systemic corticosteroids within 4 weeks prior to Visit 1, or who develop a respiratory tract infection or asthma crisis during the screening period. In the latter case, the subjects can be re-screened four weeks after the last dose of systemic corticosteroid or antibiotic.
- Subjects that received bronchial thermoplastic treatment.
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 5 mg | Drug | PBF-680 5 mg |
| PBF-680 20 mg | Drug | PBF-680 20 mg |
| Placebo | Drug | Placebo |
Primary outcome
Change in PC20 yielded from AMP airway challenge testing
Time frame: 2.25, 3.5, 8 hours post dose
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 8 Mar 2016.
- Institut d'Investigació Biomèdica Sant PauLink provided by the sponsor.
- molecule ownerLink provided by the sponsor.
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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.
2 sites 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 5 mg and PBF-680 20 mg in people with Asthma, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 2 sites 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 6 inclusion and 17 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 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in PC20 yielded from AMP airway challenge testing (time frame: 2.25, 3.5, 8 hours post dose). 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 8 Mar 2016.