AsthmaTAPAGENCT05459012
Patient Education in Pregnant Women With Asthma
An observational study of Asthma, run by CHU de Reims at 1 site in France.
Trial summary
Pregnancy may impact treatment adherence in women with asthma. This is a major risk factor for asthma exacerbation, which may have an important impact for both women and the babies. This study aims to evaluate the impact of a targeted patient education action tailored for pregnant women with asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- follow-up
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 19 Sep 2022to 31 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: women with asthma
Who may be able to join
- Adult pregnant women with asthma
Who cannot join
- women not able to speak and/or read French language
- women protected by the law
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Education: Asthma and Pregnancy
Pregnancy may impact treatment adherence in women with asthma. This is a major risk factor for asthma exacerbation, which may have an important impact for both women and the babies. This study aims to evaluate the impact of a targeted patient education action tailored for pregnant women with asthma.
- Conditions
- Asthma
- Being tested
- follow-up
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-upOther
Questionnaire of Quality of life
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with asthma | Not described Receives: Other: follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Asthma quality of life between two periods : before intervention and 3 month after the intervention
The physician gives Asthma quality of life questionnaire (AQLQ) before intervention and 3 month after the intervention
Measured: before and 3 month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start19 Sep 2022
- Primary completion27 Jun 2023
- Study completion31 Oct 2023
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 CHU de ReimsThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459012
- Sponsor's protocol ID
- PO22079*
- Acronym
- TAPAGE
- Status last verified
- Oct 2023
- First submitted
- 8 Jul 2022
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Education: Asthma and Pregnancy
- ClinicalTrials.gov ID
- NCT05459012
- Acronym / sponsor ID
- TAPAGE / PO22079*
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 14 Jul 2022 (actual)
- 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.
Pregnancy may impact treatment adherence in women with asthma. This is a major risk factor for asthma exacerbation, which may have an important impact for both women and the babies. This study aims to evaluate the impact of a targeted patient education action tailored for pregnant women with asthma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women with asthma | – | Other: follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with asthma
Key inclusion criteria (1 listed)
- Adult pregnant women with asthma
Key exclusion criteria (2 listed)
- women not able to speak and/or read French language
- women protected by the law
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 |
|---|---|---|
| follow-upQuestionnaire of Quality of life | Other | pregnant women with asthma |
Primary outcome
Change from Asthma quality of life between two periods : before intervention and 3 month after the intervention
Time frame: before and 3 month after the intervention
The physician gives Asthma quality of life questionnaire (AQLQ) before intervention and 3 month after the intervention
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 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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 CHU de Reims at 1 site in France.
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 1 inclusion and 2 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 Nov 2023. 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 France. 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?
Change from Asthma quality of life between two periods : before intervention and 3 month after the intervention (time frame: before and 3 month after the intervention). 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 21 Nov 2023.