Contraceptive Use and Respiratory Conditions Among Scottish Women

Asthma Clinical Trial

Official title:

Use of Hormonal Contraceptives in Relation to Asthma and Wheezing Disorders in Scottish Women: a Population-based Cross-sectional Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039102
• Other study ID #: 75764
• Status: Completed
• Start date: December 2013
• Est. completion date: September 2018

Study information

• Verified date: June 2021
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3257
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

Inclusion Criteria:

• Non-pregnant

• Woman

• 16-45 years old

Exclusion Criteria:

• Pregnant

• Man

• Younger than 16 years or older than 45 years old

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United Kingdom	University of Ediburgh	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported doctor-diagnosed current asthma		During the past 12 months
Secondary	Self-reported wheezing symptom		During the past 12 months
Secondary	Self-reported current treatment for asthma/wheeze		During the past 12 months