AsthmaPhase 4NCT01520688
Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth
A Phase 4 study testing Fluticasone, Budesonide, Beclomethasone, Fluticasone, Beclomethasone, Budesonide and Budesonide, Fluticasone, Beclomethasone in people with Asthma, run by West Penn Allegheny Health System at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone, Budesonide, Beclomethasone, Fluticasone, Beclomethasone, Budesonide and Budesonide, Fluticasone, Beclomethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2012to Feb 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines.
- Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days.
- Subjects will be excluded if they had more than one burst of systemic steroids within the past year.
- Subjects will be excluded if their baseline FEV1 is < 80% predicted.
- Subjects will be excluded if they have any other serious systemic disease other than asthma.
- Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days
Show all 15Show fewer
- Subjects will be excluded if they have a history of allergy to any of the study medications, milk protein or lactose.
- Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles.
- Subjects will be excluded if they have any history of tuberculosis of the respiratory tract.
- Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections.
- Subjects will be excluded if they have any history of herpes simplex infection of the eye.
- Subjects will be excluded if they have taken any immunosuppressive drugs within the past 2 months.
- Subjects will be excluded if they have any history of Churg-Strauss syndrome or other eosinophilic disorders.
- Subjects will be excluded if an investigator deems they have any mental or development health issues, such as autism, moderate to severe mental retardation or severe ADHD,that interferes with their ability to complete the knemometry measurements.
- Subjects will be excluded if an investigator deems they have any physical issues, such as inability to sit independently or amputation of lower leg, that interferes with their ability to complete the knemometry measurements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pediatric Alliance-Greentree Division
Green Tree, Pennsylvania, 15220
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: A Randomized, Cross Over Study Evaluating the Effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on Short Term Growth in Pediatric Subjects With Asthma
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.
Read the detailed description
A randomized, cross over study evaluating the effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on short term growth in pediatric subjects with asthma.
Objectives:
- The primary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus Pulmicort Flexhaler 180 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma.
- The secondary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus QVAR 80 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma.
Aims:
- The primary aim is to show that there is a growth suppressive effect of Pulmicort Flexhaler 180 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.
- The secondary aim to show that there is a growth suppressive effect of QVAR 80 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.
Hypotheses:
- The primary hypothesis is that treatment with Pulmicort Flexhaler 180mcg BID as compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by knemometry in pediatric subjects with mild asthma.
- The secondary hypothesis is that treatment with QVAR 80 mcg BID as compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by knemometry in pediatric subjects with mild asthma.
- Conditions
- Asthma
- Being tested
- Fluticasone, Budesonide, Beclomethasone, Fluticasone, Beclomethasone, Budesonide, Budesonide, Fluticasone, Beclomethasone, Budesonide, Beclomethasone, Fluticasone, Beclomethasone, Fluticasone, Budesonide
- Keywords
- Mild persistent or mild intermittent asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone, Budesonide, BeclomethasoneDrug
Also called Flovent Diskus, Pulmicort Flexhaler, QVAR
Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid
Fluticasone, Beclomethasone, BudesonideDrug
Also called Flovent Diskus, Pulmicort Flexhaler, QVAR
Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID
Budesonide, Fluticasone, BeclomethasoneDrug
Also called Pulmicort Flexhaler, Flovent Diskus, QVAR
Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID
Budesonide, Beclomethasone, FluticasoneDrug
Also called Pulmicort Flexhaler, QVAR, Flovent Diskus
Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID
Beclomethasone, Fluticasone, BudesonideDrug
Also called QVAR, Flovent Diskus, Pulmicort Flexhaler
Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID
Beclomethasone, Budesonide, FluticasoneDrug
Also called QVAR, Pulmicort Flexhaler, flovent Diskus
Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID
| Study group | Role | What they receive |
|---|---|---|
| 1 Treatment Sequence, FPQ | Experimental | Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR Receives: Drug: Fluticasone, Budesonide, Beclomethasone |
| 2 Treatment Sequence, FQP | Experimental | Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort Receives: Drug: Fluticasone, Beclomethasone, Budesonide |
| 3 Treatment Sequence, PFQ | Experimental | Period 2 Pulmicort Period 4 Flovent Period 6 QVAR Receives: Drug: Budesonide, Fluticasone, Beclomethasone |
| 4-Treatment Sequence, PQF | Experimental | Period 2 Pulmicort Period 4 QVAR Period 6 Flovent Receives: Drug: Budesonide, Beclomethasone, Fluticasone |
| 5 Treatment Sequence, QFP | Experimental | Period 2 QVAR Period 4 Flovent Period 6 Pulmicort Receives: Drug: Beclomethasone, Fluticasone, Budesonide |
| 6 Treatment Sequence, QPF | Experimental | Period 2 QVAR Period 4 Pulmicort Period 6 Flovent Receives: Drug: Beclomethasone, Budesonide, Fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
Measured: 1 yr
Secondary outcomes (1)
Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID.
Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma during treatment with Flovent Discus 100 mcg BID or QVAR 80 mcg BID.
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Gentile, West Penn Allegheny Health System
- Investigators
- Deborah A Gentile, MD, Principal investigator, Allegheny Singer Research Institute/Allegheny General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01520688
- Sponsor's protocol ID
- RC#5255
- Status last verified
- Oct 2020
- First submitted
- 24 Jan 2012
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Cross Over Study Evaluating the Effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on Short Term Growth in Pediatric Subjects With Asthma
- ClinicalTrials.gov ID
- NCT01520688
- Acronym / sponsor ID
- RC#5255
- Conditions
- Asthma
- Keywords
- Mild persistent or mild intermittent asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Posted 12 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized, cross over study evaluating the effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on short term growth in pediatric subjects with asthma.
Objectives:
- The primary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus Pulmicort Flexhaler 180 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma.
- The secondary objective of this study is to compare the effect of Flovent Diskus 100 mcg BID versus QVAR 80 mcg BID on short-term lower leg growth velocity as measured by knemometry in pediatric subjects with mild asthma.
Aims:
- The primary aim is to show that there is a growth suppressive effect of Pulmicort Flexhaler 180 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.
- The secondary aim to show that there is a growth suppressive effect of QVAR 80 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma.
Hypotheses:
- The primary hypothesis is that treatment with Pulmicort Flexhaler 180mcg BID as compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by knemometry in pediatric subjects with mild asthma.
- The secondary hypothesis is that treatment with QVAR 80 mcg BID as compared to Flovent Diskus 100 mcg BID has a growth suppressive effect on lower leg length as assessed by knemometry in pediatric subjects with mild asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 Treatment Sequence, FPQ | Experimental | Drug: Fluticasone, Budesonide, BeclomethasonePeriod 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR |
| 2 Treatment Sequence, FQP | Experimental | Drug: Fluticasone, Beclomethasone, BudesonidePeriod 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort |
| 3 Treatment Sequence, PFQ | Experimental | Drug: Budesonide, Fluticasone, BeclomethasonePeriod 2 Pulmicort Period 4 Flovent Period 6 QVAR |
| 4-Treatment Sequence, PQF | Experimental | Drug: Budesonide, Beclomethasone, FluticasonePeriod 2 Pulmicort Period 4 QVAR Period 6 Flovent |
| 5 Treatment Sequence, QFP | Experimental | Drug: Beclomethasone, Fluticasone, BudesonidePeriod 2 QVAR Period 4 Flovent Period 6 Pulmicort |
| 6 Treatment Sequence, QPF | Experimental | Drug: Beclomethasone, Budesonide, FluticasonePeriod 2 QVAR Period 4 Pulmicort Period 6 Flovent |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines.
- Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days.
- Subjects will be excluded if they had more than one burst of systemic steroids within the past year.
- Subjects will be excluded if their baseline FEV1 is < 80% predicted.
- Subjects will be excluded if they have any other serious systemic disease other than asthma.
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, Budesonide, BeclomethasoneAlso: Flovent Diskus, Pulmicort Flexhaler, QVARFluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid | Drug | 1 Treatment Sequence, FPQ |
| Fluticasone, Beclomethasone, BudesonideAlso: Flovent Diskus, Pulmicort Flexhaler, QVARFluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID | Drug | 2 Treatment Sequence, FQP |
| Budesonide, Fluticasone, BeclomethasoneAlso: Pulmicort Flexhaler, Flovent Diskus, QVARBudesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID | Drug | 3 Treatment Sequence, PFQ |
| Budesonide, Beclomethasone, FluticasoneAlso: Pulmicort Flexhaler, QVAR, Flovent DiskusBudesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID | Drug | 4-Treatment Sequence, PQF |
| Beclomethasone, Fluticasone, BudesonideAlso: QVAR, Flovent Diskus, Pulmicort FlexhalerBeclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID | Drug | 5 Treatment Sequence, QFP |
| Beclomethasone, Budesonide, FluticasoneAlso: QVAR, Pulmicort Flexhaler, flovent DiskusBeclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID | Drug | 6 Treatment Sequence, QPF |
Primary outcome
Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
Time frame: 1 yr
Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.
1 secondary outcome
Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID.
Time frame: 1 yr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Deborah A Gentile, MD principal investigator
Allegheny Singer Research Institute/Allegheny General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone, Budesonide, Beclomethasone, Fluticasone, Beclomethasone, Budesonide and Budesonide, Fluticasone, Beclomethasone in people with Asthma, run by West Penn Allegheny Health System at 2 sites in United States.
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 6 inclusion and 15 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID. (time frame: 1 yr). 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 18 Nov 2020.