AsthmaNCT02039102
Contraceptive Use and Respiratory Conditions Among Scottish Women
An observational study of Asthma, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Asthma
- How many people
- 3,257 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2013to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- Child, Adult
Study population: Non-pregnant women aged 16-45 years
Who may be able to join
- Non-pregnant
- Woman
- 16-45 years old
Who cannot join
- Pregnant
- Man
- Younger than 16 years or older than 45 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Hormonal Contraceptives in Relation to Asthma and Wheezing Disorders in Scottish Women: a Population-based Cross-sectional Survey
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.
- Conditions
- Asthma
- Keywords
- hormonal contraceptives, combined pills, progesterone-only contraceptives, body mass index, asthma, Scotland, women
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-users of hormonal contraceptives | Not described | |
| Users of hormonal contraceptives | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported doctor-diagnosed current asthma
Measured: During the past 12 months
Secondary outcomes (2)
Self-reported wheezing symptom
Measured: During the past 12 months
Self-reported current treatment for asthma/wheeze
Measured: During the past 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 3,257 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039102
- Sponsor's protocol ID
- 75764
- Status last verified
- Jun 2021
- First submitted
- 15 Jan 2014
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19121863Lange 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.
PubMed 11462063Salam 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.
PubMed 16675325
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Hormonal Contraceptives in Relation to Asthma and Wheezing Disorders in Scottish Women: a Population-based Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT02039102
- Acronym / sponsor ID
- 75764
- Conditions
- Asthma
- Keywords
- hormonal contraceptives, combined pills, progesterone-only contraceptives, body mass index, asthma, Scotland, women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,257 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-users of hormonal contraceptives | – | – |
| Users of hormonal contraceptives | – | – |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Non-pregnant women aged 16-45 years
Key inclusion criteria (3 listed)
- Non-pregnant
- Woman
- 16-45 years old
Key exclusion criteria (3 listed)
- Pregnant
- Man
- Younger than 16 years or older than 45 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-reported doctor-diagnosed current asthma
Time frame: During the past 12 months
2 secondary outcomes
Self-reported wheezing symptom
Time frame: During the past 12 months
Self-reported current treatment for asthma/wheeze
Time frame: During the past 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Background: PubMed 19121863Macsali 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.
- Background: PubMed 11462063Lange 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.
- Background: PubMed 16675325Salam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported doctor-diagnosed current asthma (time frame: During the past 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02039102, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.