CompletedPhase 4

Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth

United States32 participantsStarted 2012-02

Plain-language summary

Children with mild persistent asthma that have asthma symptoms once or twice a week and use a daily controller, while children with mild intermittent asthma rarely have asthma symptoms and do not use a daily controller. Inhaled corticosteroids are the standard treatment for mild peristent asthma. The purpose of this study is to measure children rate of growth while on different inhaled corticosteroids.

Who can participate

Age range

6 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age).
. All subjects must have a history of physician diagnosed mild intermittent or mild persistent asthma as documented by PCP medical record or detailed history by study investigator.
. All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history.
. All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination.
. Subjects may be on current treatment with montelukast as this drug does not affect growth. If a subject is on montelukast at screening/baseline, they will remain on a stable dose throughout the study.
. Subjects must be willing to comply with study requirements.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.

Timeframe: 1 yr

Trial details

NCT IDNCT01520688

SponsorWest Penn Allegheny Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-02

Results submitted2016-11-17

View on ClinicalTrials.gov More Asthma trials

Plain-language summary

Who can participate

Age range

6 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age).
. All subjects must have a history of physician diagnosed mild intermittent or mild persistent asthma as documented by PCP medical record or detailed history by study investigator.
. All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history.
. All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination.
. Subjects may be on current treatment with montelukast as this drug does not affect growth. If a subject is on montelukast at screening/baseline, they will remain on a stable dose throughout the study.
. Subjects must be willing to comply with study requirements.

Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria