Clinical trial NCT02039102: Contraceptive Use and Respiratory Conditions Among Scottish Women
Official title: Use of Hormonal Contraceptives in Relation to Asthma and Wheezing Disorders in Scottish Women: a Population-based Cross-sectional Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: hormonal contraceptives
combined pills
progesterone-only contraceptives
body mass index
asthma
Scotland
women
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 3257
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Non-pregnant women aged 16-45 years

Brief summary: Studies examining the sex differences in the epidemiology and morbidity patterns of asthma show that the rates of disease severity, healthcare utilisation, and poor quality of life are considerably higher in women than in men, and this has been attributed to endogenous and exogenous sex hormonal factors. Studies examining the impact of use of hormonal contraceptives on the risk of asthma and asthma-related conditions are few, yet findings are conflicting.

In the present study, the investigators utilize data from the Scottish Health Survey, a national representative sample, to investigate the associations between current use of hormonal contraceptives and the prevalence of self-reported doctor-diagnosed current asthma and wheezing symptoms in Scottish women. The investigators hypothesize that while current use of any hormonal contraceptives and combined oral pills are associated with higher prevalence of asthma and asthma outcomes, current use of progesterone-only contraceptives is not associated with asthma. A secondary aim of the current study is to examine whether there is evidence of any biological interaction between use of hormonal contraceptives and BMI in relation to the risk of asthma and asthma outcomes.


Eligibility criteria: Inclusion Criteria:

* Non-pregnant
* Woman
* 16-45 years old

Exclusion Criteria:

* Pregnant
* Man
* Younger than 16 years or older than 45 years old

Primary outcomes:
measure: Self-reported doctor-diagnosed current asthma
timeFrame: During the past 12 months
Secondary outcomes:
measure: Self-reported wheezing symptom
timeFrame: During the past 12 months
measure: Self-reported current treatment for asthma/wheeze
timeFrame: During the past 12 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Ediburgh
Study officials:
References:
citation: Macsali F, Real FG, Omenaas ER, Bjorge L, Janson C, Franklin K, Svanes C. Oral contraception, body mass index, and asthma: a cross-sectional Nordic-Baltic population survey. J Allergy Clin Immunol. 2009 Feb;123(2):391-7. doi: 10.1016/j.jaci.2008.10.041. Epub 2009 Jan 3.
citation: Lange P, Parner J, Prescott E, Ulrik CS, Vestbo J. Exogenous female sex steroid hormones and risk of asthma and asthma-like symptoms: a cross sectional study of the general population. Thorax. 2001 Aug;56(8):613-6. doi: 10.1136/thorax.56.8.613.
citation: Salam MT, Wenten M, Gilliland FD. Endogenous and exogenous sex steroid hormones and asthma and wheeze in young women. J Allergy Clin Immunol. 2006 May;117(5):1001-7. doi: 10.1016/j.jaci.2006.02.004.