Exploring the Impact of Sex Hormones and Obesity on Asthma Outcomes in Women with Asthma

The University of Newcastle0 sites150 target enrollmentDecember 1, 2021

Overview

No summary available.

Registry

who.int

Start Date

December 1, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Observational

Sex

Female

Sponsor

•1\.Physician diagnosed asthma
•2\.Female \>\=18 years of age
•3\.Confirmed variable airflow obstruction at screening visit or documented within the past 10 years:
•Bronchodilator response \>200mL OR \>12% (post\-bronchodilator FEV1 following administration of 400µg salbutamol, pMDI with spacer; after 10 minutes, or following administration of nebulised Ventolin)
•Airway hyperresponsiveness (in response to any standard challenge agent)
•Peak flow variability \>12% when monitored over at least one week
•FEV1 variability \>12% (between two FEV1 values measured within two months of each other)
•If not observed at screening visit or documented in file, then provide peak flow meter for two weeks monitoring, if required.
•4\.Using a combined monophasic oral contraceptive pill (Groups 3 and 4 only).
•5\.Stable disease with no respiratory infection, asthma exacerbation, corticosteroid burst (\>10mg/day) or use of antibiotics to treat an asthma exacerbation, or change in asthma therapy in the four weeks preceding visit 1\.

•1\.Asthma is not the primary respiratory diagnosis
•2\.Treatment with oral corticosteroids in the preceding four weeks (unless a low dose is being taken on a long\-term basis: \>\=10mg for \>3 months)
•3\.Current smoker, or smoked in the last six months
•4\.Perimenopausal (menstrual cycle less frequent or irregular with symptoms of estrogen insufficiency)
•5\.Pregnancy or breastfeeding
•6\.Endocrine disorder resulting in amenorrhoea (e.g. thyroid disease, hyper\-prolactinoma or known pituitary disorder)
•7\.Irregular menstrual cycle (variability \>15 days between shortest and longest cycle over 12 months or cycle length outside the range of 26\-34 days)
•8\.Hormonal contraceptive use (other than the combined monophasic oral contraceptive pill for Groups 3 and 4\)
•9\.Current lung cancer or other blood, lymphatic or solid organ malignancy
•10\.NSAID burst within 48 hours of study visit