AsthmaPhase 4NCT01550471
Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis
A Phase 4 study of Asthma and Allergic Rhinitis, run by West Penn Allegheny Health System at 2 sites in United States.
Trial summary
This study will provide the clinicians guidance on the safest combination of inhaled and nasal corticosteroids for children with mild asthma and allergic rhinitis respectively; however, one safety concern is that these products are independently known to have dose-related effects on short term and intermediate term… Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Allergic Rhinitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2012to Aug 2015
- 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 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects will include females and males 6 to 15 years of age.
- All subjects must have a history of physician diagnosed mild asthma and allergic rhinitis 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.
- 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
- 1. Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines.
- 2 Subjects will be excluded if they used any systemic steroids within the past 60 days.
- 3. Subjects will be excluded if they had more than one burst of systemic steroids within the past year.
- 4. Subjects will be excluded if their baseline FEV1 is < 80% predicted. 5. Subjects will be excluded if they have any other serious systemic disease other than asthma.
- 6. Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days 7. Subjects will be excluded if they have a history of allergy to any of the study medications.
- 8. Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles.
Show all 13Show fewer
- 9. Subjects will be excluded if they have any history of tuberculosis of the respiratory tract.
- 10. Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections.
- 11. Subjects will be excluded if they have any history of herpes simplex infection of the eye.
- 12. Subjects will be excluded if they have taken any immunosuppressive drugs within the past 2 months.
- 13. Subjects will be excluded if they have any history of Churg-Strauss syndrome or other eosinophilic disorders.
- 14. 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.
- 15. 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
Alleghney General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
Official title: A Study Evaluating the Effect of Omnaris Nasal Spray 200 mcg QD & Alvesco Inhalation Aerosol 80 BID vs Beconase AQ Nasal Spray 168 mcg BID & QVAR Inhalation Aerosol 40 mcg BID vs Placebo Nasal Spray QD & Placebo Inhalation Aerosol BID on Short Term Growth in Pediatric Subjects With Mild Asthma & Allergic Rhinitis
This study will provide the clinicians guidance on the safest combination of inhaled and nasal corticosteroids for children with mild asthma and allergic rhinitis respectively; however, one safety concern is that these products are independently known to have dose-related effects on short term and intermediate term growth. Knemometry is a non invasive technique for measuring short-term lower leg growth in children and is currently the method of choice in growth studies of short duration. Subjects will be seen on a weekly basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.
Read the detailed description
This will be a single-center, cross-over study evaluating the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID versus Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID on short term growth in pediatric subjects with mild asthma and allergic rhinitis. During the course of the study, subjects will be seen on a weekly basis and lower leg length will be measured using knemometry. Knemometry is a non invasive technique for measuring short-term lower leg growth in children and is currently the method of choice in growth studies of short duration. During the run-in and wash-out periods, subjects will not be treated with any medications or placebos. During the active treatment periods, subjects will be treated with Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID or Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID, or Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID. Eligible subjects will be randomized into the study which will contain one run-in period (Period 1), 3 active treatment periods (Periods 2, 4 and 6) and 2 washout periods (Periods 3 and 5). Each period will be of 3 weeks duration and the entire study duration will be 18 weeks. Subjects will be seen on a weekly basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.
- Conditions
- Asthma, Allergic Rhinitis
- Being tested
- Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase, QVAR/Beconase, Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris, Placebo/Placebo, Alvesco/Omnaris, QVAR/Beconase
- Keywords
- Mild asthma and allergic rhinitis
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alvesco/Omnaris, QVAR/Beconase, Placebo/PlaceboDrug
Also called Ciclesonide, Beclomethasone, Placebo
Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID
Alvesco/Omnaris, Placebo/Placebo, QVAR/BeconaseDrug
Also called Ciclesonide, Placebo, Beclomethasone
Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID
QVAR/Beconase, Alvesco/Omnaris, Placebo/PlaceboDrug
Also called Beclomethasone, Ciclesonide, Placebo
QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID
QVAR/Beconase, Placebo/Placebo, Alvesco/OmnarisDrug
Also called Beclomethasone, Placebo, Ciclesonide
QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD
Placebo/Placebo, Alvesco/Omnaris, QVAR/BeconaseDrug
Also called Placebo, Ciclesonide, Beclomethasone
Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID
Placebo/Placebo, QVAR/Beconase, Alvesco/OmnarisDrug
Also called Placebo, Beclomethasone, Ciclesonide
Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD
| Study group | Role | What they receive |
|---|---|---|
| 1 Treatment Sequence-A and O, Q and B, P and P | Experimental | Period 2-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 4-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 6-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Receives: Drug: Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo |
| 2 Treatment Sequence-A and O, P and P, Q and B | Experimental | Period 2-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 4-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 6-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Receives: Drug: Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase |
| 3 Treatment Sequence-Q and B, A and O, P and P | Experimental | Period 2-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 4-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 6-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Receives: Drug: QVAR/Beconase, Alvesco/Omnaris, Placebo/Placebo |
| 4 Treatment Sequence-Q and B, P and P, A and O | Experimental | Period 2-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 4-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 6-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Receives: Drug: QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris |
| 5 Treatment Sequence-P and P, A and O, Q and B | Experimental | Period 2-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 4-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 6-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Receives: Drug: Placebo/Placebo, Alvesco/Omnaris, QVAR/Beconase |
| 6 Treatment Sequence-P and P, Q and B, A and O | Experimental | Period 2-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 4-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 6-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Receives: Drug: Placebo/Placebo, QVAR/Beconase, Alvesco/Omnaris |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Beconase AQ Nasal Spray & QVAR Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.
To evaulate the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID on- short-term lower leg growth as measured by knemometry in children with mild asthma and allergic rhinitis.
Measured: 1 yr
Secondary outcomes (1)
The Effects of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Placebo Nasal Spray & Placebo Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.
To evaluate growth suppressive effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID as compared to Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID on short-term lower leg growth velocity as measured by knemometry in children with mild asthma and allergic rhinitis.
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 posted12 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2015
- Study completionAug 2015
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
- 22 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 General Hospital/Allegheny Singer Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550471
- Sponsor's protocol ID
- RC#5401
- Status last verified
- Oct 2020
- First submitted
- 19 Feb 2012
- Last updated
- 4 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 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Effect of Omnaris Nasal Spray 200 mcg QD & Alvesco Inhalation Aerosol 80 BID vs Beconase AQ Nasal Spray 168 mcg BID & QVAR Inhalation Aerosol 40 mcg BID vs Placebo Nasal Spray QD & Placebo Inhalation Aerosol BID on Short Term Growth in Pediatric Subjects With Mild Asthma & Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01550471
- Acronym / sponsor ID
- RC#5401
- Conditions
- Asthma, Allergic Rhinitis
- Keywords
- Mild asthma and allergic rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Posted 14 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will provide the clinicians guidance on the safest combination of inhaled and nasal corticosteroids for children with mild asthma and allergic rhinitis respectively; however, one safety concern is that these products are independently known to have dose-related effects on short term and intermediate term growth. Knemometry is a non invasive technique for measuring short-term lower leg growth in children and is currently the method of choice in growth studies of short duration. Subjects will be seen on a weekly basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.
Detailed description
This will be a single-center, cross-over study evaluating the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID versus Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID on short term growth in pediatric subjects with mild asthma and allergic rhinitis. During the course of the study, subjects will be seen on a weekly basis and lower leg length will be measured using knemometry. Knemometry is a non invasive technique for measuring short-term lower leg growth in children and is currently the method of choice in growth studies of short duration. During the run-in and wash-out periods, subjects will not be treated with any medications or placebos. During the active treatment periods, subjects will be treated with Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID or Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID, or Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID. Eligible subjects will be randomized into the study which will contain one run-in period (Period 1), 3 active treatment periods (Periods 2, 4 and 6) and 2 washout periods (Periods 3 and 5). Each period will be of 3 weeks duration and the entire study duration will be 18 weeks. Subjects will be seen on a weekly basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 Treatment Sequence-A and O, Q and B, P and P | Experimental | Drug: Alvesco/Omnaris, QVAR/Beconase, Placebo/PlaceboPeriod 2-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 4-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 6-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID |
| 2 Treatment Sequence-A and O, P and P, Q and B | Experimental | Drug: Alvesco/Omnaris, Placebo/Placebo, QVAR/BeconasePeriod 2-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 4-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 6-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID |
| 3 Treatment Sequence-Q and B, A and O, P and P | Experimental | Drug: QVAR/Beconase, Alvesco/Omnaris, Placebo/PlaceboPeriod 2-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 4-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 6-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID |
| 4 Treatment Sequence-Q and B, P and P, A and O | Experimental | Drug: QVAR/Beconase, Placebo/Placebo, Alvesco/OmnarisPeriod 2-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 4-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 6-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD |
| 5 Treatment Sequence-P and P, A and O, Q and B | Experimental | Drug: Placebo/Placebo, Alvesco/Omnaris, QVAR/BeconasePeriod 2-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 4-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 6-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID |
| 6 Treatment Sequence-P and P, Q and B, A and O | Experimental | Drug: Placebo/Placebo, QVAR/Beconase, Alvesco/OmnarisPeriod 2-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 4-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 6-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects will include females and males 6 to 15 years of age.
- All subjects must have a history of physician diagnosed mild asthma and allergic rhinitis 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.
- 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.
Key exclusion criteria (13 listed)
- 1. Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines.
- 2 Subjects will be excluded if they used any systemic steroids within the past 60 days.
- 3. Subjects will be excluded if they had more than one burst of systemic steroids within the past year.
- 4. Subjects will be excluded if their baseline FEV1 is < 80% predicted. 5. Subjects will be excluded if they have any other serious systemic disease other than asthma.
- 6. Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days 7. Subjects will be excluded if they have a history of allergy to any of the study medications.
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 |
|---|---|---|
| Alvesco/Omnaris, QVAR/Beconase, Placebo/PlaceboAlso: Ciclesonide, Beclomethasone, PlaceboAlvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID | Drug | 1 Treatment Sequence-A and O, Q and B, P and P |
| Alvesco/Omnaris, Placebo/Placebo, QVAR/BeconaseAlso: Ciclesonide, Placebo, BeclomethasoneAlvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID | Drug | 2 Treatment Sequence-A and O, P and P, Q and B |
| QVAR/Beconase, Alvesco/Omnaris, Placebo/PlaceboAlso: Beclomethasone, Ciclesonide, PlaceboQVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID | Drug | 3 Treatment Sequence-Q and B, A and O, P and P |
| QVAR/Beconase, Placebo/Placebo, Alvesco/OmnarisAlso: Beclomethasone, Placebo, CiclesonideQVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD | Drug | 4 Treatment Sequence-Q and B, P and P, A and O |
| Placebo/Placebo, Alvesco/Omnaris, QVAR/BeconaseAlso: Placebo, Ciclesonide, BeclomethasonePlacebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID | Drug | 5 Treatment Sequence-P and P, A and O, Q and B |
| Placebo/Placebo, QVAR/Beconase, Alvesco/OmnarisAlso: Placebo, Beclomethasone, CiclesonidePlacebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD | Drug | 6 Treatment Sequence-P and P, Q and B, A and O |
Primary outcome
The Effect of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Beconase AQ Nasal Spray & QVAR Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.
Time frame: 1 yr
To evaulate the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID on- short-term lower leg growth as measured by knemometry in children with mild asthma and allergic rhinitis.
1 secondary outcome
The Effects of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Placebo Nasal Spray & Placebo Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.
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 4 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Deborah A Gentile, MD principal investigator
Allegheny General Hospital/Allegheny Singer Research Institute
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 of Asthma and Allergic Rhinitis, 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 5 inclusion and 13 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 4 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 14 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?
The Effect of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Beconase AQ Nasal Spray & QVAR Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis. (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 4 Nov 2020.