Trials / Completed
CompletedNCT02635945
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 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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Palobiofarma SL · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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). 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PBF-680 | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2019-09-30
- Completion
- 2019-11-30
- First posted
- 2015-12-21
- Last updated
- 2020-06-30
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT02635945. Inclusion in this directory is not an endorsement.