Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 yr |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deborah A Gentile, MD | Allegheny General Hospital/Allegheny Singer Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Alliance-Greentree Division | Green Tree | Pennsylvania | 15220 | United States | ||
| Alleghney General Hospital |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A and O, Then Q and B, Then P and P | Treatment Order: Alvesco and Omnaris; QVAR and Beconase; Placebo and Placebo |
| FG001 | A and O, Then P and P, Then Q and B | Treatment Order: Alvesco and Omnaris; Placebo and Placebo; QVAR and Beconase |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-In Period (3 Weeks) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 |
|
|
| Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase | Drug | 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/Placebo | Drug | 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/Omnaris | Drug | 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/Beconase | Drug | 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/Omnaris | Drug | 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 |
|
|
| 1 yr |
| Pittsburgh |
| Pennsylvania |
| 15212 |
| United States |
| FG002 | Q and B, Then A and O, Then P and P | Treatment Order: QVAR and Beconase; Alvesco and Omnaris; Placebo and Placebo |
| FG003 | Q and B, Then P and P, Then A and O | Treatment Order: Qvar and Beconase; Placebo and Placebo; Alvesco and Omnaris |
| FG004 | P and P, Then A and O, Then Q and B | Treatment Order: Placebo and Placebo; Alvesco and Omnaris; Qvar and Beconase |
| FG005 | P and P, Then Q and B, Then A and O | Treatment Order: Placebo and Placebo; Qvar and Beconase; Alvesco and Omnaris |
| COMPLETED |
|
| NOT COMPLETED |
|
| First Treatment Period (3 Weeks) |
|
| First Wash Out Period (3 Weeks) |
|
| Second Treatment Period (3 Weeks) |
|
| Second Wash Out Period (3 Weeks) |
|
| Third Treatment Period (3 Weeks) |
|
| Third Wash Out Period (3 Weeks) |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | mm/wk | 1 yr |
|
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | mm/wk | 1 yr |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alvesco and Omnaris | 0 | 21 | 0 | 21 | 7 | 21 | |
| EG001 | Qvar and Beconase | 0 | 22 | 0 | 22 | 7 | 22 | |
| EG002 | Placebo and Placebo | 0 | 22 | 0 | 22 | 6 | 22 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headaches/migraine | General disorders |
| |||
| Respiratory infections | Respiratory, thoracic and mediastinal disorders |
| |||
| Sinus infection | General disorders |
| |||
| Pharyngitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Foot pain during sports | General disorders |
| |||
| Swollen eyelid and adenopathy | Eye disorders |
| |||
| Sprained ankle | Musculoskeletal and connective tissue disorders |
| |||
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
| |||
| Viral gastroenteritis | Gastrointestinal disorders |
| |||
| Impetigo | Skin and subcutaneous tissue disorders |
| |||
| Bilateral otitis media | Ear and labyrinth disorders |
| |||
| Mouth pain | General disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Gentile, Principal Investigator | Allegheny Health Network | 412-359-4099 | dgentile@wpahs.org |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C120481 | ciclesonide |
| D001507 | Beclomethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|