A Study Evaluating the Effect of Inhaled and Nasal Corticosteroids on Short Term Growth in Pediatric Subjects With Mild Asthma & Allergic Rhinitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by West Penn Allegheny Health System
Sponsor:
Information provided by (Responsible Party):
Deborah Gentile, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT01550471
First received: February 19, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Allergic Rhinitis
Drug: Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo
Drug: Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase
Drug: QVAR/Beconase, Alvesco/Omnaris, Placebo/Placebo
Drug: QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris
Drug: Placebo/Placebo, Alvesco/Omnaris, QVAR/Beconase
Drug: Placebo/Placebo, QVAR/Beconase, Alvesco/Omnaris
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 in children with mild asthma and allergic rhinitis.


Secondary Outcome Measures:
  • The Effects of Omnaris, Alvesco, Beconase AQ and QVAR 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 ] [ Designated as safety issue: No ]

    A)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.

    B)To evaluate growth suppressive effect of Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID as compared to Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID in children with mild asthma and allergic rhinitis.



Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Treatment Sequence-A/O, Q/B, P/P
Period 2-Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD Period 4-QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID Period 6-Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID
Drug: Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo
Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID
Other Name: Ciclesonide, Beclomethasone, Placebo
Experimental: 2 Treatment Sequence-A/O, P/P, Q/B
Period 2-Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD Period 4-Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID Period 6-QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID
Drug: Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase
Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID
Other Name: Ciclesonide, Placebo, Beclomethasone
Experimental: 3 Treatment Sequence-Q/B, A/O, P/P
Period 2-QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID Period 4-Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD Period 6-Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID
Drug: QVAR/Beconase, Alvesco/Omnaris, Placebo/Placebo
QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID
Other Name: Beclomethasone, Ciclesonide, Placebo
Experimental: 4 Treatment Sequence-Q/B, P/P, A/O
Period 2-QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID Period 4-Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID Period 6-Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD
Drug: QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris
QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID, Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD
Other Name: Beclomethasone, Placebo, Ciclesonide
Experimental: 5 Treatment Sequence-P/P, A/O, Q/B
Period 2-Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID Period 4-Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD Period 6-QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID
Drug: Placebo/Placebo, Alvesco/Omnaris, QVAR/Beconase
Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD, QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID
Other Name: Placebo, Ciclesonide, Beclomethasone
Experimental: 6 Treatment Sequence-P/P, Q/B, A/O
Period 2-Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID Period 4-QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID Period 6-Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD
Drug: Placebo/Placebo, QVAR/Beconase, Alvesco/Omnaris
Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID/Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID/Omnaris Nasal Spray 200 mcg QD
Other Name: Placebo, Beclomethasone, Ciclesonide

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.

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects will include females and males 12 to 15 years of age.
  2. 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.
  3. All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history.
  4. 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.
  5. Subjects must be willing to comply with study requirements.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550471

Contacts
Contact: Deborah A Gentile, MD 412-359-6645 dgentile@wpahs.org
Contact: Joseph Arcari, DO 412-922-5250

Locations
United States, Pennsylvania
Pediatric Alliance-Greentree Division Recruiting
Greentree, Pennsylvania, United States, 15220
Contact: Joseph Aracri, DO    412-922-5250    aracrij@pediatricalliance.com   
Contact: Deborah A Gentile, MD    412-359-6645    dgentile@wpahs.org   
Sub-Investigator: Joseph Aracri, DO         
Alleghney General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Deborah A Gentile, MD    412-359-6645    dgentile@wpahs.org   
Contact: David P Skoner, MD    412-359-6643    dskoner@wpahs.org   
Principal Investigator: Deborah A Gentile, MD         
Sponsors and Collaborators
West Penn Allegheny Health System
Investigators
Principal Investigator: Deborah A Gentile, MD Allegheny General Hospital/Allegheny Singer Research Institute
  More Information

No publications provided

Responsible Party: Deborah Gentile, Principal Investigator, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT01550471     History of Changes
Other Study ID Numbers: RC#5401
Study First Received: February 19, 2012
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:
Mild asthma and allergic rhinitis

Additional relevant MeSH terms:
Asthma
Rhinitis
Rhinitis, Allergic, Perennial
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Beclomethasone
Ciclesonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 31, 2014