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Article: Elexacaftor/tezacaftor/ivacaftor as rescue therapy in a patient with the cystic fibrosis genotype

Salvatore, Donatello / Colangelo, Carmela / D'Andria, Michele / Marsicovetere, Giovanni / Passarella, Domenica

2021 Volume 9, Issue 8, Page(s) e04713

Abstract: ... ...

Abstract	Elexacaftor
Language	English
Publishing date	2021-08-25
Publishing country	England
Document type	Case Reports
ZDB-ID	2740234-4
ISSN	2050-0904
ISSN	2050-0904
DOI	10.1002/ccr3.4713
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Article: Elexacaftor/Tezacaftor/Ivacaftor in Patients with Cystic Fibrosis Homozygous for the

Carnovale, Vincenzo / Iacotucci, Paola / Terlizzi, Vito / Colangelo, Carmela / Ferrillo, Lorenza / Pepe, Angela / Francalanci, Michela / Taccetti, Giovanni / Buonaurio, Serena / Celardo, Assunta / Salvadori, Laura / Marsicovetere, Giovanni / D'Andria, Michele / Ferrara, Nicola / Salvatore, Donatello

Journal of clinical medicine

2022 Volume 11, Issue 4

Abstract: Background: Elexacaftor/tezacaftor/ivacaftor (ETI) is the newest cystic fibrosis transmembrane conductance regulator (: Methods: Retrospective observational study in : Results: ppFEV: Conclusions: ... ...

Abstract	Background: Elexacaftor/tezacaftor/ivacaftor (ETI) is the newest cystic fibrosis transmembrane conductance regulator ( Methods: Retrospective observational study in Results: ppFEV Conclusions: In
Language	English
Publishing date	2022-02-16
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662592-1
ISSN	2077-0383
ISSN	2077-0383
DOI	10.3390/jcm11041021
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Article ; Online: Airway Clearance with Expiratory Flow Accelerator Technology: Effectiveness of the "Free Aspire" Device in Patients with Severe COPD.

Patrizio, Giorgia / D'Andria, Michele / D'Abrosca, Francesco / Cabiaglia, Antonella / Tanzi, Fabio / Garuti, Giancarlo / Nicolini, Antonello

Turkish thoracic journal

2019 Volume 20, Issue 4, Page(s) 209–215

Abstract: Objectives: Chronic obstructive pulmonary disease (COPD) is associated with a higher risk of pulmonary infections. This risk not only negatively affects patients' quality of life but also increases social and health costs. Hence, there is a need for an ... ...

Abstract	Objectives: Chronic obstructive pulmonary disease (COPD) is associated with a higher risk of pulmonary infections. This risk not only negatively affects patients' quality of life but also increases social and health costs. Hence, there is a need for an effective rehabilitative treatment including airway clearance. The aim of this pilot study was to evaluate the efficacy of a new tool for bronchial clearance based on expiratory flow accelerator (EFA) technology compared with positive expiratory pressure (PEP) treatment. Materials and methods: Twenty stable patients with COPD, Global Initiative for Chronic Obstructive Lung Disease 3-4 stage, were enrolled and allocated to treatment with EFA or Bubble-PEP (BP) for 20 days during a pulmonary rehabilitation program. At baseline and the end of treatment, the following parameters were measured: arterial blood gases (ABG); respiratory function, including peak cough expiratory flow (PCEF), maximal inspiratory pressure (MIP), and maximal expiratory pressure exercise capacity using the 6-minute walk test (6MWT), dyspnea using the Medical Research Council scale, and quality of life using the St. George's Respiratory Questionnaire. Results: Expiratory flow accelerator showed a significant pre- and post-improvement in ABG and a significantly greater improvement than BP in PCEF, MIP, and 6MWT post-treatment. Conclusion: Expiratory flow accelerator is a valid device compared with BP as an adjunctive therapy for the treatment of patients with severe COPD.
Language	English
Publishing date	2019-07-30
Publishing country	Turkey
Document type	Journal Article
ISSN	2149-2530
ISSN (online)	2149-2530
DOI	10.5152/TurkThoracJ.2018.18053
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Article ; Online: Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor Therapy in Three Subjects with the Cystic Fibrosis Genotype Phe508del/Unknown and Advanced Lung Disease.

Terlizzi, Vito / Colangelo, Carmela / Marsicovetere, Giovanni / D'Andria, Michele / Francalanci, Michela / Innocenti, Diletta / Masi, Eleonora / Avarello, Angelo / Taccetti, Giovanni / Amato, Felice / Comegna, Marika / Castaldo, Giuseppe / Salvatore, Donatello

Genes

2021 Volume 12, Issue 8

Abstract: We evaluated the effectiveness and safety of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in three subjects carrying ... ...

Abstract	We evaluated the effectiveness and safety of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in three subjects carrying the
MeSH term(s)	Adult ; Aminophenols/administration & dosage ; Aminophenols/therapeutic use ; Benzodioxoles/administration & dosage ; Benzodioxoles/therapeutic use ; Chloride Channel Agonists/administration & dosage ; Chloride Channel Agonists/therapeutic use ; Cystic Fibrosis/drug therapy ; Cystic Fibrosis/genetics ; Cystic Fibrosis Transmembrane Conductance Regulator/chemistry ; Cystic Fibrosis Transmembrane Conductance Regulator/genetics ; Drug Therapy, Combination ; Female ; Genotype ; Humans ; Indoles/administration & dosage ; Indoles/therapeutic use ; Middle Aged ; Phenylalanine/chemistry ; Pyrazoles/administration & dosage ; Pyrazoles/therapeutic use ; Pyridines/administration & dosage ; Pyridines/therapeutic use ; Pyrrolidines/administration & dosage ; Pyrrolidines/therapeutic use ; Quinolones/administration & dosage ; Quinolones/therapeutic use ; Retrospective Studies
Chemical Substances	Aminophenols ; Benzodioxoles ; CFTR protein, human ; Chloride Channel Agonists ; Indoles ; Pyrazoles ; Pyridines ; Pyrrolidines ; Quinolones ; tezacaftor ; Cystic Fibrosis Transmembrane Conductance Regulator (126880-72-6) ; ivacaftor (1Y740ILL1Z) ; Phenylalanine (47E5O17Y3R) ; elexacaftor (RRN67GMB0V)
Language	English
Publishing date	2021-07-29
Publishing country	Switzerland
Document type	Journal Article ; Observational Study
ZDB-ID	2527218-4
ISSN	2073-4425 ; 2073-4425
ISSN (online)	2073-4425
ISSN	2073-4425
DOI	10.3390/genes12081178
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Article ; Online: Comparison of an expiratory flow accelerator device versus positive expiratory pressure for tracheobronchial airway clearance after lung cancer lobectomy: a preliminary study.

Rotolo, Nicola / Cattoni, Maria / D'Andria, Michele / Cavanna, Laura / Patrizio, Giorgia / Imperatori, Andrea / Nicolini, Antonello

Physiotherapy

2019 Volume 110, Page(s) 34–41

Abstract: Objective: A new type of device has recently been introduced in chest physiotherapy as an aid to tracheo-bronchial airway clearance: expiratory flow accelerator (EFA). It promotes mucus clearance without generating any pressure gradient, allowing ... ...

Abstract	Objective: A new type of device has recently been introduced in chest physiotherapy as an aid to tracheo-bronchial airway clearance: expiratory flow accelerator (EFA). It promotes mucus clearance without generating any pressure gradient, allowing patients to breathe at tidal volume against no resistance. Design: Pilot randomized controlled study. Setting: Tertiary hospital. Participants: Fifty adult patients who underwent lung cancer lobectomy were randomized to undergo chest physiotherapy with EFA (n=26) or PEP (n=24). Interventions: EFA; PEP bottle. Main outcomes: Incidence of postoperative pulmonary complications (PPC) and length of stay. Secondary outcomes: trends in inspiratory capacity, respiratory rate, oxygen saturation, and dyspnoea. Patients rated user-friendliness of the two devices on a 5-point Likert scale. Results: A slightly different incidence of PPCs was observed between the EFA and PEP group. Nevertheless, the length of stay was similar in the two groups. No substantial differences were seen in trends of inspiratory capacity, respiratory rate, oxygen saturation, dyspnoea between the two groups. Patient-reported user-friendliness of the two devices did not differ significantly, although the use of the EFA device appeared less strenuous. Conclusions: Results of this pilot study point to the use of EFA as an alternative treatment option rather than as a replacement for the PEP bottle in chest physiotherapy following lung cancer lobectomy. EFA may be preferable for weaker patients and/or with airway leakages in whom PEP has limited indications. Further investigation in a larger sample is required to statistically confirm the findings. Clinical Trial Registration Number ChiCTR-ONC-17013255.
MeSH term(s)	Aged ; Female ; Humans ; Length of Stay ; Lung Neoplasms/physiopathology ; Lung Neoplasms/surgery ; Male ; Middle Aged ; Pilot Projects ; Pneumonectomy ; Positive-Pressure Respiration/instrumentation ; Positive-Pressure Respiration/methods ; Postoperative Complications/therapy ; Respiratory Function Tests ; Respiratory Therapy/instrumentation ; Respiratory Therapy/methods
Language	English
Publishing date	2019-01-26
Publishing country	England
Document type	Comparative Study ; Journal Article ; Randomized Controlled Trial
ZDB-ID	391109-3
ISSN	1873-1465 ; 0031-9406
ISSN (online)	1873-1465
ISSN	0031-9406
DOI	10.1016/j.physio.2019.01.011
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Article: Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor Therapy in Three Subjects with the Cystic Fibrosis Genotype Phe508del/Unknown and Advanced Lung Disease

Terlizzi, Vito / Colangelo, Carmela / Marsicovetere, Giovanni / D’Andria, Michele / Francalanci, Michela / Innocenti, Diletta / Masi, Eleonora / Avarello, Angelo / Taccetti, Giovanni / Amato, Felice / Comegna, Marika / Castaldo, Giuseppe / Salvatore, Donatello

Genes. 2021 July 29, v. 12, no. 8

2021

Abstract: We evaluated the effectiveness and safety of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in three subjects carrying the Phe508del/unknown CFTR genotype. An ex vivo analysis on nasal epithelial cells (NEC) indicated a significant improvement of CFTR ... ...

Abstract	We evaluated the effectiveness and safety of elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA) in three subjects carrying the Phe508del/unknown CFTR genotype. An ex vivo analysis on nasal epithelial cells (NEC) indicated a significant improvement of CFTR gating activity after the treatment. Three patients were enrolled in an ELX/TEZ/IVA managed-access program, including subjects with the highest percent predicted Forced Expiratory Volume in the 1st second (ppFEV₁) < 40 in the preceding 3 months. Data were collected at baseline and after 8, 12 and 24 weeks of follow-up during treatment. All patients showed a considerable decrease of sweat chloride (i.e., meanly about 60 mmol/L as compared to baseline), relevant improvement of ppFEV₁ (i.e., >8) and six-minute walk test, and an increase in body mass index after the first 8 weeks of treatment. No pulmonary exacerbations occurred during the 24 weeks of treatment and all domains of the CF Questionnaire-Revised improved. No safety concerns related to the treatment occurred. This study demonstrates the benefit from the ELX/TEZ/IVA treatment in patients with CF with the Phe508del and one unidentified CFTR variant. The preliminary ex vivo analysis of the drug response on NEC helps to predict the in vivo therapeutic endpoints.
Keywords	body mass index ; chlorides ; cystic fibrosis ; drugs ; epithelium ; genotype ; nose ; sweat ; therapeutics
Language	English
Dates of publication	2021-0729
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2527218-4
ISSN	2073-4425
ISSN	2073-4425
DOI	10.3390/genes12081178
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Effectiveness and safety of elexacaftor/tezacaftor/ivacaftor in patients with cystic fibrosis and advanced lung disease with the Phe508del/minimal function genotype.

Carnovale, Vincenzo / Iacotucci, Paola / Terlizzi, Vito / Colangelo, Carmela / Medio, Pietro / Ferrillo, Lorenza / De Gregorio, Fabiola / Francalanci, Michela / Taccetti, Giovanni / Buonaurio, Serena / d'Ippolito, Marcella / Marsicovetere, Giovanni / D'Andria, Michele / Ferrara, Nicola / Salvatore, Donatello

Respiratory medicine

2021 Volume 189, Page(s) 106646

Abstract: Background: Elexacaftor/tezacaftor/ivacaftor (E/T/I) is a cystic fibrosis transmembrane conductance regulator (CFTR) triple combination therapy used for the treatment of cystic fibrosis (CF) in patients aged ≥12 years who have at least one copy of the ... ...

Abstract	Background: Elexacaftor/tezacaftor/ivacaftor (E/T/I) is a cystic fibrosis transmembrane conductance regulator (CFTR) triple combination therapy used for the treatment of cystic fibrosis (CF) in patients aged ≥12 years who have at least one copy of the Phe508del mutation (F) in the CFTR gene or another mutation that is responsive to treatment with E/T/I. This study determined the effectiveness and safety of E/T/I treatment in a cohort of CF patients. Methods: This retrospective cohort study collected data from the first 6 months of treatment of patients with CF, compound heterozygotes for the F and a minimal function (MF) mutations, enrolled in an E/T/I compassionate use program only available to patients having ppFEV Results: After 6 months of treatment, the mean (standard deviation (SD)) SCC decreased from 91.1 (19.3) mmol/L to 46.2 (24.2) mmol/L. The decrease of SCC was accompanied by improvement of lung function (mean (95% Confidence Interval (CI) absolute increase in ppFEV Conclusions: E/T/I was clinically effective and safe in patients with advanced CF lung disease with an F/MF genotype.
MeSH term(s)	Adolescent ; Adult ; Aminophenols/therapeutic use ; Benzodioxoles/therapeutic use ; Chloride Channel Agonists/therapeutic use ; Cystic Fibrosis/drug therapy ; Cystic Fibrosis/genetics ; Cystic Fibrosis/physiopathology ; Drug Therapy, Combination ; Female ; Genotype ; Humans ; Indoles/therapeutic use ; Male ; Middle Aged ; Pyrazoles/therapeutic use ; Pyridines/therapeutic use ; Pyrrolidines/therapeutic use ; Quinolones/therapeutic use ; Respiratory Function Tests ; Retrospective Studies
Chemical Substances	Aminophenols ; Benzodioxoles ; Chloride Channel Agonists ; Indoles ; Pyrazoles ; Pyridines ; Pyrrolidines ; Quinolones ; tezacaftor ; ivacaftor (1Y740ILL1Z) ; elexacaftor (RRN67GMB0V)
Language	English
Publishing date	2021-10-12
Publishing country	England
Document type	Journal Article
ZDB-ID	1003348-8
ISSN	1532-3064 ; 0954-6111
ISSN (online)	1532-3064
ISSN	0954-6111
DOI	10.1016/j.rmed.2021.106646
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Article ; Online: Minimum Clinically Important Difference in 30-s Sit-to-Stand Test After Pulmonary Rehabilitation in Subjects With COPD.

Zanini, Andrea / Crisafulli, Ernesto / D'Andria, Michele / Gregorini, Cristina / Cherubino, Francesca / Zampogna, Elisabetta / Azzola, Andrea / Spanevello, Antonio / Schiavone, Nicola / Chetta, Alfredo

Respiratory care

2019 Volume 64, Issue 10, Page(s) 1261–1269

Abstract: Background: The sit-to-stand (STS) test is a feasible tool for measuring peripheral muscle strength of the lower limbs. There is evidence of increasing use of STS tests in patients with COPD. We sought to evaluate in subjects with COPD the minimum ... ...

Abstract	Background: The sit-to-stand (STS) test is a feasible tool for measuring peripheral muscle strength of the lower limbs. There is evidence of increasing use of STS tests in patients with COPD. We sought to evaluate in subjects with COPD the minimum clinically important difference in 30-s STS test after pulmonary rehabilitation. Methods: Stable COPD subjects undergoing a 30-s STS test and a 6-min walk test (6MWT) before and after pulmonary rehabilitation were included. Responsiveness to pulmonary rehabilitation was determined by the change in 30-s STS test results (Δ 30-s STS) before and after pulmonary rehabilitation. The minimum clinically important difference was evaluated using an anchor-based method. Results: 96 subjects with moderate-to-severe COPD were included. At baseline, 30-s STS test results were significantly related to distance covered in a 6MWT (6MWD) ( Conclusions: Our study indicates that in stable subjects with moderate-to-severe COPD, the 30-s STS test was a sensitive tool to assess the efficacy of pulmonary rehabilitation. A Δ 30-s STS of ≥ 2 repetitions represented the minimum clinically important difference, which may be predicted by the baseline ability in the 30-s STS test and lung function in terms of diffusing lung capacity (ClinicalTrials.gov registration NCT03627624).
MeSH term(s)	Aged ; Area Under Curve ; Calcium Hydroxide ; Dyspnea/etiology ; Exercise Test ; Female ; Humans ; Male ; Middle Aged ; Minimal Clinically Important Difference ; Pulmonary Diffusing Capacity ; Pulmonary Disease, Chronic Obstructive/complications ; Pulmonary Disease, Chronic Obstructive/physiopathology ; Pulmonary Disease, Chronic Obstructive/rehabilitation ; Residual Volume ; Retrospective Studies ; Vital Capacity ; Walk Test
Chemical Substances	Reocap E (85746-53-8) ; Calcium Hydroxide (PF5DZW74VN)
Language	English
Publishing date	2019-07-03
Publishing country	United States
Document type	Journal Article
ZDB-ID	603252-7
ISSN	1943-3654 ; 0098-9142 ; 0020-1324
ISSN (online)	1943-3654
ISSN	0098-9142 ; 0020-1324
DOI	10.4187/respcare.06694
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Article: Effects of salmeterol on arterial oxyhemoglobin saturations in patients with cystic fibrosis.

Salvatore, Donatello / D'Andria, Michele

Pediatric pulmonology

2002 Volume 34, Issue 1, Page(s) 11–15

Abstract: Sleep-related oxygen desaturation has been described in patients with cystic fibrosis (CF). Thus we studied the effects of inhaled Salmeterol xinafoate, a long-acting beta-2 agonist, on transcutaneous oxyhemoglobin saturation in sleeping, stable CF ... ...

Abstract	Sleep-related oxygen desaturation has been described in patients with cystic fibrosis (CF). Thus we studied the effects of inhaled Salmeterol xinafoate, a long-acting beta-2 agonist, on transcutaneous oxyhemoglobin saturation in sleeping, stable CF patients. Patients with stable CF (n = 23) were divided into responders and nonresponders to beta-2 agonists, based on an albuterol challenge during daytime testing, and then they received salmeterol before sleep, in a double-blind crossover design. Overnight oxyhemoglobin saturation measurements and spirometry on awakening were performed. Salmeterol administration before sleep resulted in statistically significant increases in mean arterial oxyhemoglobin saturation and in FEV(1) and FEF(25-75) on awakening compared to placebo values, but only in patients responding to daytime albuterol inhalation by showing improvement in lung function. We conclude that salmeterol inhalation at bedtime could prevent or reduce nocturnal hypoxemia in daytime albuterol-responsive CF patients, thus improving the long-term clinical outcome of CF lung disease.
MeSH term(s)	Administration, Inhalation ; Adrenergic beta-Agonists/therapeutic use ; Adult ; Albuterol/analogs & derivatives ; Albuterol/therapeutic use ; Cystic Fibrosis/blood ; Cystic Fibrosis/drug therapy ; Female ; Humans ; Hypoxia/drug therapy ; Male ; Oxyhemoglobins/analysis ; Salmeterol Xinafoate
Chemical Substances	Adrenergic beta-Agonists ; Oxyhemoglobins ; Salmeterol Xinafoate (6EW8Q962A5) ; Albuterol (QF8SVZ843E)
Language	English
Publishing date	2002-07
Publishing country	United States
Document type	Clinical Trial ; Controlled Clinical Trial ; Journal Article
ZDB-ID	632784-9
ISSN	1099-0496 ; 8755-6863
ISSN (online)	1099-0496
ISSN	8755-6863
DOI	10.1002/ppul.10117
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