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.
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|ClinicalTrials.gov Identifier: NCT02635945|
Recruitment Status : Completed
First Posted : December 21, 2015
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: PBF-680 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||September 30, 2019|
|Actual Study Completion Date :||November 30, 2019|
Experimental: PBF-680 10 mg
2 capsules: PBF-680, 5 mg capsules for oral administration (excipient: 76 mg microcrystalline cellulose).
Placebo Comparator: Placebo
2 capsules: Placebo to PBF-680, as 95.12 mg microcrystalline cellulose capsules.
- 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. ]
- 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 ]Leukocyte subpopulations from cytocentrifuged, stained preparations will be counted and expressed as percentage cell numbers per volume unit.
- Adverse events [ Time Frame: 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)
- Vital signs [ Time Frame: 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.
- Number of Participants With Abnormal Laboratory Values [ Time Frame: 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).
- Physical examination [ Time Frame: 7 times during 2 months ]
- Electrocardiogram (EKG) [ Time Frame: 3 times during 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635945
|Unitat de Pneumologia Experimental|
|Barcelona, Spain, 08025|