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

Not Applicable

Recruiting

Conditions: Asthma
Respiratory - Asthma
Diet and Nutrition - Obesity

Registration Number: ACTRN12621001656820

Lead Sponsor: The University of Newcastle

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 150

Inclusion Criteria

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.
6.Able to provide written informed consent

Exclusion Criteria

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
11.Participant has a clinically important medical illness (including serious psychological disorders) likely to interfere with management or participation in the study