AsthmaNCT01681979
WEUSRTP4850: Phase II: ICS/LABA Use in Pregnancy and Outcomes
An observational study of Asthma, run by GlaxoSmithKline.
Trial summary
Asthma is reported to affect between 3-14% of pregnancies making asthma medicines one of the most commonly used classes of medicines during pregnancy. Maternal asthma and in particular poorly controlled asthma has been found to be associated with a number of adverse perinatal outcomes including preterm delivery, low… Read more about this study
- Who is it for?
- Ages 11 to 50 years, women only
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone propionate (with and without concurrent salmeterol)
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Aug 2013
- 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 11 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of all eligible pregnancies identified from the source population where the female is considered to have asthma. The source population will be all pregnancies identified on the GPRD that started and ended between 1 January 2000 and 31 December 2010.
Who may be able to join
- female patients whose pregnancy was registered on the GPRD and started and ended between 1 January 2000 and 31 December 2010
- Patients are considered to have asthma based on diagnosis and prescription codes
Who cannot join
- patients not registered with a practice contributing up-to-standard data to the GPRD for the 6 months before the start of pregnancy, throughout pregnancy and for the 3 months following the pregnancy end date.
- patients not 11-50 years of age on the pregnancy start date
- patients who experienced multiple birth (twins, triplets)
- patients with a medical code for a diagnosis of chronic obstructive pulmonary disease (COPD) or any other chronic respiratory condition (e.g. cystic fibrosis) recorded at anytime before the pregnancy end date
About this study
Official title: WEUSRTP4850: Phase II: Asthma Treatment in Pregnancy and the Frequency of Adverse Pregnancy Outcomes
Asthma is reported to affect between 3-14% of pregnancies making asthma medicines one of the most commonly used classes of medicines during pregnancy. Maternal asthma and in particular poorly controlled asthma has been found to be associated with a number of adverse perinatal outcomes including preterm delivery, low birth weight and pre-eclampsia. At present little is known about the safety in humans of many anti-asthma medicines when used during pregnancy. As a result all inhaled corticosteroids, with the exception of budesonide which is category B, have an FDA pregnancy category C, indicative of the fact there are no adequate and well controlled studies in humans.
Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often in combination with the long-acting β-agonist salmeterol. Owing to small numbers of pregnancy exposures in the past, little is known about the safety of fluticasone propionate when used during pregnancy. A recent feasibility study, however, has shown that there are sufficient numbers of first trimester exposed pregnancies on the General Practice Research Database (GPRD) to allow the overall risk of major congenital malformations (MCMs) to be evaluated. This study also demonstrated that using data from the GPRD it is possible to determine an individual's exposure to anti-asthma medicines during pregnancy and to classify her treatment in terms of the British Thoracic Society treatment steps based on linked prescription and primary care data.
Read more
The aims of this study are to 1) evaluate the safety profile of fluticasone propionate (FP) compared with exposure to all other inhaled corticosteroids with all major congenital malformations combined as the primary endpoint, whilst taking into account potential confounders and exposure to other anti-asthma medicine; and 2) test the null hypothesis that exposure to fluticasone propionate during the first trimester of pregnancy is not associated with increased overall risk of all major congenital malformations when compared to the risk in those exposed to other inhaled corticosteroids during the first trimester of pregnancy.
The study will be a retrospective cohort study and will use data from the United Kingdom's General Practice Research Database (GPRD). The GPRD contains longitudinal medical records collected within UK primary care. All medical symptoms and diagnoses are recorded in the database, including those relating to pregnancy, in the form of Read Codes. In addition to coded data GPs have the option of recording un-coded comments ('free text'), such as more detailed descriptions of diagnoses or treatments along with information provided to them via hospital letters, referrals and discharge summaries.
As the recording of stillbirths, neonatal deaths and pre-term births on the GPRD has not been verified, a verification exercise will be carried out. This will involve requesting and reviewing free text comments for 100 stillbirths, 100 neonatal deaths and 100 pre-term births. Free text comments will be requested if they are associated with a medical code related to pregnancy, delivery, post natal visits, death, post mortem, hospital letters and other forms of communication. If the free text is not found to be informative we will send questionnaires to the woman's GP.
All outcomes will be identified and verified blinded to asthma treatment and severity levels.
- Conditions
- Asthma
- Being tested
- Fluticasone propionate (with and without concurrent salmeterol)
- Keywords
- fluticasone propionate, asthma, pregnancy, major congenital malformations
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionate (with and without concurrent salmeterol)Drug
Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often in combination with the long-acting β-agonist salmeterol. For the primary endpoint, exposure status will be determined based on the individual receiving a prescription for the drug of interest (fluticasone propionate or another inhaled corticosteroid) in the 2 weeks immediately before the LMP date or during the first trimester of pregnancy.
Sensitivity analysis will be carried out categorising exposure based on mapping the duration of prescriptions based on the number of inhalers, number of puffs within an inhaler and the prescribed daily dose.
| Study group | Role | What they receive |
|---|---|---|
| Women with asthma during pregnancy | Women with asthma during pregnancy will be identified based on one of the following: 1) an asthma related medical code recorded anytime before the pregnancy start date and at least one prescription for an asthma medicine in the 6 months before the pregnancy start date or during pregnancy; 2) no asthma related medical code but at least 6 prescriptions for an asthma medicine in their record before the pregnancy start date, including one in the 6 months before the pregnancy start date or during pregnancy. Receives: Drug: Fluticasone propionate (with and without concurrent salmeterol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All major congenital malformations (MCMs) combined
Measured: 11 years (January 1, 2000 to December 31, 2010)
Secondary outcomes (1)
Secondary outcomes associated with measures of asthma control, not drug exposures of interest including Spontaneous pregnancy losses, pre-term births, and Stillbirths and neonatal deaths.
Spontaneous pregnancy losses will be defined as losses that occurred > 24 wks gestation from the date of the first day of the last menstrual period (LMP) (identified based on the pregnancy algorithm). For pregnancy losses where the type of loss is unknown any free text comments associated with the code will be requested \& reviewed. Pre-term births will be defined as a live birth delivered at <37 complete wks gestation from the date of the first day of the LMP (identified based on medical codes for a pre-term delivery in addition to gestational age \& first day of LMP). Stillbirths =>24 wks.
Measured: 11 years (January 1, 2000 to December 31, 2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681979
- Sponsor's protocol ID
- 114593
- Other IDs
- WEUSRTP4850, EPI40638
- Status last verified
- Sep 2014
- First submitted
- 6 Sep 2012
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEUSRTP4850: Phase II: Asthma Treatment in Pregnancy and the Frequency of Adverse Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT01681979
- Acronym / sponsor ID
- 114593
- Conditions
- Asthma
- Keywords
- fluticasone propionate, asthma, pregnancy, major congenital malformations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Sep 2012 (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.
Asthma is reported to affect between 3-14% of pregnancies making asthma medicines one of the most commonly used classes of medicines during pregnancy. Maternal asthma and in particular poorly controlled asthma has been found to be associated with a number of adverse perinatal outcomes including preterm delivery, low birth weight and pre-eclampsia. At present little is known about the safety in humans of many anti-asthma medicines when used during pregnancy. As a result all inhaled corticosteroids, with the exception of budesonide which is category B, have an FDA pregnancy category C, indicative of the fact there are no adequate and well controlled studies in humans.
Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often in combination with the long-acting β-agonist salmeterol. Owing to small numbers of pregnancy exposures in the past, little is known about the safety of fluticasone propionate when used during pregnancy. A recent feasibility study, however, has shown that there are sufficient numbers of first trimester exposed pregnancies on the General Practice Research Database (GPRD) to allow the overall risk of major congenital malformations (MCMs) to be evaluated. This study also demonstrated that using data from the GPRD it is possible to determine an individual's exposure to anti-asthma medicines during pregnancy and to classify her treatment in terms of the British Thoracic Society treatment steps based on linked prescription and primary care data.
The aims of this study are to 1) evaluate the safety profile of fluticasone propionate (FP) compared with exposure to all other inhaled corticosteroids with all major congenital malformations combined as the primary endpoint, whilst taking into account potential confounders and exposure to other anti-asthma medicine; and 2) test the null hypothesis that exposure to fluticasone propionate during the first trimester of pregnancy is not associated with increased overall risk of all major congenital malformations when compared to the risk in those exposed to other inhaled corticosteroids during the first trimester of pregnancy.
The study will be a retrospective cohort study and will use data from the United Kingdom's General Practice Research Database (GPRD). The GPRD contains longitudinal medical records collected within UK primary care. All medical symptoms and diagnoses are recorded in the database, including those relating to pregnancy, in the form of Read Codes. In addition to coded data GPs have the option of recording un-coded comments ('free text'), such as more detailed descriptions of diagnoses or treatments along with information provided to them via hospital letters, referrals and discharge summaries.
As the recording of stillbirths, neonatal deaths and pre-term births on the GPRD has not been verified, a verification exercise will be carried out. This will involve requesting and reviewing free text comments for 100 stillbirths, 100 neonatal deaths and 100 pre-term births. Free text comments will be requested if they are associated with a medical code related to pregnancy, delivery, post natal visits, death, post mortem, hospital letters and other forms of communication. If the free text is not found to be informative we will send questionnaires to the woman's GP.
All outcomes will be identified and verified blinded to asthma treatment and severity levels.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with asthma during pregnancy | – | Drug: Fluticasone propionate (with and without concurrent salmeterol)Women with asthma during pregnancy will be identified based on one of the following: 1) an asthma related medical code recorded anytime before the pregnancy start date and at least one prescription for an asthma medicine in the 6 months before the pregnancy start date or during pregnancy; 2) no asthma related medical code but at least 6 prescriptions for an asthma medicine in their record before the pregnancy start date, including one in the 6 months before the pregnancy start date or during pregnancy. |
Who may qualify
- Ages
- 11 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of all eligible pregnancies identified from the source population where the female is considered to have asthma. The source population will be all pregnancies identified on the GPRD that started and ended between 1 January 2000 and 31 December 2010.
Key inclusion criteria (2 listed)
- female patients whose pregnancy was registered on the GPRD and started and ended between 1 January 2000 and 31 December 2010
- Patients are considered to have asthma based on diagnosis and prescription codes
Key exclusion criteria (4 listed)
- patients not registered with a practice contributing up-to-standard data to the GPRD for the 6 months before the start of pregnancy, throughout pregnancy and for the 3 months following the pregnancy end date.
- patients not 11-50 years of age on the pregnancy start date
- patients who experienced multiple birth (twins, triplets)
- patients with a medical code for a diagnosis of chronic obstructive pulmonary disease (COPD) or any other chronic respiratory condition (e.g. cystic fibrosis) recorded at anytime before the pregnancy end date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone propionate (with and without concurrent salmeterol)Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often in combination with the long-acting β-agonist salmeterol. For the primary endpoint, exposure status will be determined based on the individual receiving a prescription for the drug of interest (fluticasone propionate or another inhaled corticosteroid) in the 2 weeks immediately before the LMP date or during the first trimester of pregnancy. Sensitivity analysis will be carried out categorising exposure based on mapping the duration of prescriptions based on the number of inhalers, number of puffs within an inhaler and the prescribed daily dose. | Drug | Women with asthma during pregnancy |
Primary outcome
All major congenital malformations (MCMs) combined
Time frame: 11 years (January 1, 2000 to December 31, 2010)
1 secondary outcome
Secondary outcomes associated with measures of asthma control, not drug exposures of interest including Spontaneous pregnancy losses, pre-term births, and Stillbirths and neonatal deaths.
Time frame: 11 years (January 1, 2000 to December 31, 2010)
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 1 Oct 2014.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline.
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 2 inclusion and 4 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 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
All major congenital malformations (MCMs) combined (time frame: 11 years (January 1, 2000 to December 31, 2010)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2014.