Trial · NCT02635945
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.
NCT02635945, Phase 2, Completed, Palobiofarma SL
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT02635945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02635945
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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.
- NCT number
- NCT02635945
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Palobiofarma SL
- Conditions
- Asthma
- Interventions
- PBF-680, Placebo
- First posted
- 2015-12-21
- Last updated
- 2020-06-30
- Other registries' IDs
- eudract:2015-001957-34
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Late Asthmatic Response (LAR) , measured as the fall of the forced expiratory volume (FEV1) between 3 and 10 hours postallergen bronchoprovocation | 3-to-10 hour post-allergen bronchoprovocation. | |
| Secondary | Early Asthmatic Response (EAR), measured as the maximum FEV1 fall from the postdiluent value | within 1 hour post-allergen bronchoprovocation. | |
| Secondary | hyperresponsiveness to AMP in terms of provocative concentration causing a 20% fall (PC20) increment in response to AMP airway challenge | 24-hour post-allergen bronchoprovocation | |
| Secondary | Nitric oxide fraction in exhaled air (FeNO) on post-allergen bronchoprovocation day | 6th treatment period day | |
| Secondary | Total leukocytes per mL in induced sputum on post-allergen bronchoprovocation day | 6th treatment period day | |
| Secondary | Leukocyte differential counts per mL in induced sputum on post-allergen bronchoprovocation day. | 6th treatment period day | Leukocyte subpopulations from cytocentrifuged, stained preparations will be counted and expressed as percentage cell numbers per volume unit. |
| Secondary | Adverse events | 2 Months | 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) |
| Secondary | Vital signs | 9 times during 2 months | 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. |
| Secondary | Number of Participants With Abnormal Laboratory Values | 4 times during 2 months | 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). |
| Secondary | Physical examination | 7 times during 2 months |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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/NCT02635945
GET https://conductscience.org/api/trials/v1/NCT02635945/registered