Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV
Asthma
Correlation
FEV1
Home-measurement
In-clinic measurement
PEF
Tiotropium
Journal
Respiratory research
ISSN: 1465-993X
Titre abrégé: Respir Res
Pays: England
ID NLM: 101090633
Informations de publication
Date de publication:
18 Jul 2019
18 Jul 2019
Historique:
received:
25
01
2019
accepted:
01
07
2019
entrez:
20
7
2019
pubmed:
20
7
2019
medline:
17
1
2020
Statut:
epublish
Résumé
The primary lung function endpoint in clinical trials in adolescent and adult patients with asthma is usually forced expiratory volume in one second (FEV For this assessment, we calculated post hoc the correlation between pre-dose FEV Across all 8 trials included in this analysis, changes in lung function from baseline correlated well between pre-dose FEV Pre-dose PEF measured at home could be an alternative primary lung function endpoint for trials in adolescent and adult patients with asthma. Using home-measured PEF could facilitate trial conduct and improve the convenience for patients by relocating scheduled assessments from the clinic to the patient's home. Adolescents aged 12 to 17 years: RubaTinA-asthma® ( NCT01257230 ), PensieTinA-asthma® ( NCT01277523 ). Adults aged 18 to 75 years: GraziaTinA-asthma® ( NCT01316380 ), MezzoTinA-asthma® ( NCT01172808 / NCT01172821 ), CadenTinA-asthma® ( NCT01340209 ), PrimoTinA-asthma® ( NCT00772538 / NCT00776984 ). All from Clinicaltrials.gov ( https://clinicaltrials.gov/ ).
Sections du résumé
BACKGROUND
BACKGROUND
The primary lung function endpoint in clinical trials in adolescent and adult patients with asthma is usually forced expiratory volume in one second (FEV
METHODS
METHODS
For this assessment, we calculated post hoc the correlation between pre-dose FEV
RESULTS
RESULTS
Across all 8 trials included in this analysis, changes in lung function from baseline correlated well between pre-dose FEV
CONCLUSIONS
CONCLUSIONS
Pre-dose PEF measured at home could be an alternative primary lung function endpoint for trials in adolescent and adult patients with asthma. Using home-measured PEF could facilitate trial conduct and improve the convenience for patients by relocating scheduled assessments from the clinic to the patient's home.
TRIAL REGISTRATION
BACKGROUND
Adolescents aged 12 to 17 years: RubaTinA-asthma® ( NCT01257230 ), PensieTinA-asthma® ( NCT01277523 ). Adults aged 18 to 75 years: GraziaTinA-asthma® ( NCT01316380 ), MezzoTinA-asthma® ( NCT01172808 / NCT01172821 ), CadenTinA-asthma® ( NCT01340209 ), PrimoTinA-asthma® ( NCT00772538 / NCT00776984 ). All from Clinicaltrials.gov ( https://clinicaltrials.gov/ ).
Identifiants
pubmed: 31319851
doi: 10.1186/s12931-019-1119-6
pii: 10.1186/s12931-019-1119-6
pmc: PMC6637596
doi:
Banques de données
ClinicalTrials.gov
['NCT01172808', 'NCT01257230', 'NCT00776984', 'NCT01277523', 'NCT01340209', 'NCT01172821', 'NCT01316380', 'NCT00772538']
Types de publication
Comparative Study
Journal Article
Meta-Analysis
Langues
eng
Sous-ensembles de citation
IM
Pagination
159Subventions
Organisme : Boehringer Ingelheim
ID : N/A
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