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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by West Penn Allegheny Health System
Sponsor:
Information provided by (Responsible Party):
Deborah Gentile, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT01520688
First received: January 24, 2012
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Fluticasone, Budesonide, Beclomethasone
Drug: Fluticasone, Beclomethasone, Budesonide
Drug: Budesonide, Fluticasone, Beclomethasone
Drug: Budesonide, Beclomethasone, Fluticasone
Drug: Beclomethasone, Fluticasone, Budesonide
Drug: Beclomethasone, Budesonide, Fluticasone
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 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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. [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
    The treatment with Pulmicort Flexhaler 180 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.


Secondary Outcome Measures:
  • To show that there is a growth suppressive effect of QVAR 890 mcg BID versus Flovent Diskus 100 mcg BID in children with mild asthma. [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
    The 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.


Estimated Enrollment: 60
Study Start Date: February 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Treatment Sequence, FPQ
Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR
Drug: Fluticasone, Budesonide, Beclomethasone
Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid
Other Names:
  • Flovent Diskus
  • Pulmicort Flexhaler
  • QVAR
Experimental: 2 Treatment Sequence, FQP
Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort
Drug: Fluticasone, Beclomethasone, Budesonide
Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID
Other Names:
  • Flovent Diskus
  • Pulmicort Flexhaler
  • QVAR
Experimental: 3 Treatment Sequence, PFQ
Period 2 Pulmicort Period 4 Flovent Period 6 QVAR
Drug: Budesonide, Fluticasone, Beclomethasone
Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID
Other Names:
  • Pulmicort Flexhaler
  • Flovent Diskus
  • QVAR
Experimental: 4-Treatment Sequence, PQF
Period 2 Pulmicort Period 4 QVAR Period 6 Flovent
Drug: Budesonide, Beclomethasone, Fluticasone
Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID
Other Names:
  • Pulmicort Flexhaler
  • QVAR
  • Flovent Diskus
Experimental: 5 Treatment Sequence, QFP
Period 2 QVAR Period 4 Flovent Period 6 Pulmicort
Drug: Beclomethasone, Fluticasone, Budesonide
Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID
Other Names:
  • QVAR
  • Flovent Diskus
  • Pulmicort Flexhaler
Experimental: 6 Treatment Sequence, QPF
Period 2 QVAR Period 4 Pulmicort Period 6 Flovent
Drug: Beclomethasone, Budesonide, Fluticasone
Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID
Other Names:
  • QVAR
  • Pulmicort Flexhaler
  • flovent Diskus

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:

  1. 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.
  2. 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:

  1. 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.
  2. 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:

  1. 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.
  2. 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.
  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age).
  2. 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.
  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. All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination.
  5. 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.
  6. 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 or nasal 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, milk protein or lactose.
  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: NCT01520688

Contacts
Contact: Deborah A Gentile, MD 412-359-4099
Contact: Joseph Aracri, 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   
Allegheny 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   
Sponsors and Collaborators
West Penn Allegheny Health System
Investigators
Principal Investigator: Deborah A Gentile, MD Allegheny Singer Research Institute/Allegheny General Hospital
  More Information

No publications provided

Responsible Party: Deborah Gentile, Principal Investigator, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT01520688     History of Changes
Other Study ID Numbers: RC#5255
Study First Received: January 24, 2012
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by West Penn Allegheny Health System:
Mild persistent or mild intermittent asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Beclomethasone
Budesonide
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014