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New treatment option for Chronic Cough
Official title Finnish Children´s Protracted Cough
ClinicalTrials.gov ID: NCT07582549
What this study is testing
What is Fluticasone propionate inhalation?
Fluticasone propionate inhalation is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic cough.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Prolonged cough lasting more than four weeks is common in children, but the best treatment is often unclear when no underlying disease can be found. This study aims to find out whether commonly used treatments help children with prolonged cough more effectively than placebo.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 6
You may be able to join if
- Prolonged cough lasting continuously for more than 4 weeks
- No chronic disease requiring continuous medication (i.e. a generally healthy child)
- No previous physician-diagnosed condition associated with prolonged cough episodes
- No physician-identified symptoms or findings suggestive of an underlying disease
- No prior physician-diagnosed allergic reaction or other severe or life-threatening adverse reaction to the investigational medicinal products...
You likely can't join if
- Children with symptoms or findings suggestive of an underlying cause of cough, including:
- A previously physician-diagnosed disease associated with prolonged cough
- Clinical examination or history at the study visit raising suspicion of a disease associated with prolonged cough (positive "cough pointers")
- Abnormal lung function test
- Abnormal chest X-ray (peribronchial markings are permitted) Additional exclusion criteria:
- Prior physician-diagnosed allergic reaction or other severe or life-threatening adverse reaction to the investigational medicinal products
See the full eligibility criteria
- Prolonged cough lasting continuously for more than 4 weeks
- No chronic disease requiring continuous medication (i.e. a generally healthy child)
- No previous physician-diagnosed condition associated with prolonged cough episodes
- No physician-identified symptoms or findings suggestive of an underlying disease
- No prior physician-diagnosed allergic reaction or other severe or life-threatening adverse reaction to the investigational medicinal products (fluticasone or amoxicillin-clavulanic acid)
- No simultaneous participation in another clinical drug trial
- Parents/guardians have sufficient spoken and written Finnish language proficiency
- Written, voluntary informed consent provided by a parent or legal guardian
- Children with symptoms or findings suggestive of an underlying cause of cough, including:
- A previously physician-diagnosed disease associated with prolonged cough
- Clinical examination or history at the study visit raising suspicion of a disease associated with prolonged cough (positive "cough pointers")
- Abnormal lung function test
- Abnormal chest X-ray (peribronchial markings are permitted) Additional exclusion criteria:
- Prior physician-diagnosed allergic reaction or other severe or life-threatening adverse reaction to the investigational medicinal products
- Simultaneous participation in another clinical drug trial
- Prolonged cough that has resolved spontaneously prior to the study visit
The study team makes the final eligibility decision.
Where it's taking place
- Tampere, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampere, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.