Trial · NCT03774290
Study to Investigate the Effect of PBF-680 on Forced Expiratory Volume in 1 Second (FEV1) in Asthmatic Patients
NCT03774290, Phase 2, Completed, Palobiofarma SL
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Investigate the Effect of PBF-680 on Forced Expiratory Volume in 1 Second (FEV1) in Asthmatic Patients. Trials, record NCT03774290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03774290
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Investigate the Effect of PBF-680 on Forced Expiratory Volume in 1 Second (FEV1) in Asthmatic Patients
- NCT number
- NCT03774290
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- Palobiofarma SL
- Conditions
- Asthma
- Interventions
- PBF-680, Placebo oral capsule
- First posted
- 2018-12-12
- Last updated
- 2020-09-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of PBF-680 on trough forced expiratory volume in 1 second (FEV1) | 16 Days | Defined as the average of the FEV1 measurements taken at 23h 15min and 23h 45min post-dose after the final dose. |
| Secondary | Effect of PBF-680 in the FEV1 area under curve AUC30min-23h 30min post-dose | 16 days | Defined as the FEV1 area under curve of a serial of spirometries from 30min-23h 30min post-dose through days 15-to-16 |
| Secondary | Effect of PBF-680 in the standardized FEV1 AUC30min-6h post- dose | 15 Days | Defined as the FEV1 area under curve of a serial of spirometries from 30min-6h post-dose on day 15 |
| Secondary | Effect of PBF-680 in the pre-bronchodilator FEV1 | 8 days | Defined as the FEV1 before use of bronchodilator at pre-dose spirometry on day 8 |
| Secondary | Effect of PBF-680 in the post- bronchodilator FEV1 at pre-dose spirometry on day 8 | Day 8 and Day 16 | Defined as the FEV1 after use of bronchodilator at pre-dose spirometry on day 8 and 16 |
| Secondary | Effect of PBF-680 on the asthma control as measured by Asthma Questionnaires | Day 8 and Day 15 | 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) |
| Secondary | Effect of PBF-680 on daily, morning and evening FEV1 and PEF as measured by an electronic diary/Peak Expiratory Flow (PEF) meter device. | 16 days | On each morning and evening, the subjects must fill the diary questions and record three brief expiratory maneuvers that generate PEF and FEV1 data. |
| Secondary | Effect of PBF-680 in the use of rescue bronchodilator as reported by the subject using an electronic diary/PEF meter device. | 16 days | On each morning and evening, the subjects must fill the diary questions and record three brief expiratory maneuvers that generate PEF and FEV1 data |
| Secondary | Number of subjects with treatment-related adverse events as assessed by CTCAE v4 | 16 days | Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03774290
GET https://conductscience.org/api/trials/v1/NCT03774290/registered