A single-centre, randomised, double-blind, placebo-controlled, cross-over 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.
- Conditions
- Treatment for asthma.MedDRA version: 18.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2015-001957-34-ES
- Lead Sponsor
- Palobiofarma S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 16
Subjects eligible for inclusion into the screening period and to perform the visits V1 and V2 test-based selection procedures must fulfill all of the following criteria:
1. Male and female adults aged >=18, who have signed the informed consent form prior to initiation of any study procedures.
2. Subjects who have controlled asthma, diagnosed and determined as such as per the GINA guidelines, with low-to-medium dose ICS as maintenance monotherapy and inhaled, short-acting ?2-agonist bronchodilator as rescue medication, for a minimum 4-week period before screening visit V1. Controlled asthma under the stated therapy can be the current, stable condition presented at visits V0 and V1 or can be achieved through GINA guideline-based clinical practice through one or more discretionary V0b visits.
3. Subjects must have a body mass index between 18 and 35 kg/m².
4. Subjects must be able to perform acceptable spirometry in accordance with ATS/ERS criteria for acceptability and repeatability.
5. Subjects must have a baseline FEV1>=70% of predicted normal, and greater than 1 L in absolute value, on visit V1.
6. Subjects meeting criterion 1 must have a positive skin prick allergy test to at least one tested aeroallergen, defined as causing a >=2 mm wheal, on visit V1.
7. Subjects meeting criteria 1 and 2 must show airway hyperresponsiveness to AMP, defined as per an AMP PC20<=200 mg/mL, on visit V1.
8. On visit V2, subjects meeting criteria 1, 2 and 3 must develop a LAR following bronchoprovocation with the chosen allergen, defined as a FEV1 drop >=15% from post-diluent FEV1, in at least three time points between 4 and 10 hours post-bronchoprovocation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects eligible for inclusion into the screening period and randomization must not meet any of the following criteria:
1. Current smokers, smokers within six months prior to Visit V1, or subjects with a smoking history greater than 10 packs-years.
2. Asthmatics classed as intermittent asthma managed in GINA-1 therapeutic step or asthmatics that need any maintenance controller medication beyond low-to-medium ICS.
3. Patients under any immunosuppressive medication whether asthma-related or indicated for any concomitant morbidities.
4. Subjects with a history of life-threatening asthma attacks (i.e. requiring ICU admission, orotracheal intubation).
5. Subjects with a history of a respiratory tract infection or an asthma exacerbation requiring the use of antibiotics and/or systemic corticosteroids within 4 weeks prior to visit V1, or who develop a respiratory tract infection or asthma exacerbation during the screening period. In the latter case, the subjects can be re-screened 4 weeks after the last dose of systemic corticosteroid or antibiotic.
6. Subjects that received bronchial thermoplasty treatment.
7. Subjects with a concomitant pulmonary or thoracic disease other than asthma that may compromise safety or interfere with efficacy outcomes 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.
8. Subjects with any skin condition such as demographism that may prevent correct interpretation of skin prick allergy tests.
9. Subjects with symptoms of angina pectoris or with a history of confirmed coronary disease or cardiomyopathy.
10. 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 EKG on visit V1, or any other EKG abnormality deemed clinically significant by the investigator.
11. Subjects who have a clinically significant laboratory abnormality at screening blood analysis on visit V2+24h.
12. Subjects with current uncontrolled arterial hypertension.
13. 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 VFU. 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.
14. Women supplying lactation.
15. Receipt of any investigational drug or biological therapy within 3 months before randomization in this study, or within 5 half-lives of the investigational agent, whichever is longer. Subjects ever treated with omalizumab or other biological therapies for asthma are not eligible
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method