Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05189613
Other study ID # PoliclinicoUC
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date December 31, 2022

Study information

Verified date January 2022
Source Policlinico Universitario, Catania
Contact Raffaele Campisi, Medicine
Phone +393392659722
Email raffaelemd@hotmail.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Asthma is a chronic respiratory disorder characterized by bronchial inflammation and reversible bronchial obstruction. Severe asthma is an extremely heterogeneous disease, often associated with several comorbidities and risk factors. Severe uncontrolled asthma associated with bronchiectasis is an emerging phenotype. Several studies have attempted to establish an association between asthma and bronchiectasis. Mepolizumab, an Interleukin-5 (IL-5) antagonist, reduces exacerbations, eosinophils, and improves pulmonary function and asthma control. IL-5 is pivotal to eosinophils maturation and release from bone marrow, their subsequent accumulation, activation and persistence in the tissues. IL-5 therefore represents an attractive target to prevent or blunt eosinophils-mediated inflammation. The investigators hypothesize that eosinophils, stimulated by IL-5, play a crucial role in severe asthma and BE pathogenesis.


Description:

Read more »
Read more »

Study Design


Intervention

Biological:
Mepolizumab
Subcutaneous Mepolizumab (100 mcg) injection in patients with severe eosinophilic asthma

Locations

Country Name City State
Italy AOU Policlinico "G. Rodolico-Sto arrivando!n Marco" Catania

Sponsors (1)

Lead Sponsor Collaborator
Policlinico Universitario, Catania

Country where clinical trial is conducted

Italy, 

References & Publications (11)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline of Asthma Control Test (ACT) score at Week 12 (T3), at Week 24 (T6) and at Week 52 (T12). Asthma Control Test (ACT) score is validated five-points scoring system, self-administered assessing the control of Asthma.
Scores range from 5 points (worst asthma control) to 25 points (better asthma control).
Change = Week 12 (T3) - Baseline score; Week 24 (T6) - Baseline score; Week 52 (T12) - Baseline score.
Baseline and Week 52
Secondary Change from Baseline values of Spirometry values (expressed in Litre) at Week 12 (T3), at Week 24 (T6) and at Week 52 (T12). Spirometry assess the airways obstruction. Spirometry will be performed according to American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines.
The main benchmarks for assessing airways obstruction are: Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC), expressed in Litre (L) respectively.
Change = Week 12 (T3) - Baseline values; Week 24 (T6) - Baseline values; Week 52 (T12) - Baseline values.
Baseline and Week 52
See also
  Status Clinical Trial Phase
Completed NCT05034900 - Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis? N/A
Recruiting NCT04101448 - Prevalence of Bronchiectasis in COPD Patients
Withdrawn NCT03376204 - Pain Mechanisms in Patients With Bronchiectasis
Completed NCT02550821 - Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects
Completed NCT02656992 - Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis N/A
Completed NCT02048397 - Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis N/A
Completed NCT01615484 - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability N/A
Completed NCT02282202 - Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD N/A
Recruiting NCT01761214 - Bacteriology and Inflammation in Bronchiectasis N/A
Recruiting NCT02527486 - Seoul National University Airway Registry N/A
Completed NCT01578681 - ELTGOL and Bronchiectasis. Respiratory Therapy N/A
Completed NCT01854788 - 3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis N/A
Completed NCT00769119 - A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis Phase 2
Terminated NCT00524095 - Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Phase 2
Completed NCT01117493 - Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis N/A
Recruiting NCT00129350 - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation Phase 1
Completed NCT00656721 - Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients N/A
Completed NCT04081740 - Biological Determinants of Sputum Rheology in Chronic Airway Diseases
Enrolling by invitation NCT02546297 - Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis Phase 4
Completed NCT03628456 - Effect of HFCWO Vests on Spirometry Measurements N/A