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

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:
NCT01520688
First received: January 24, 2012
Last updated: February 6, 2014
Last verified: February 2014

January 24, 2012
February 6, 2014
February 2012
December 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01520688 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Drug: Fluticasone, Budesonide, Beclomethasone
    Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid
    Other Names:
    • Flovent Diskus
    • Pulmicort Flexhaler
    • QVAR
  • Drug: Fluticasone, Beclomethasone, Budesonide
    Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID
    Other Names:
    • Flovent Diskus
    • Pulmicort Flexhaler
    • QVAR
  • Drug: Budesonide, Fluticasone, Beclomethasone
    Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID
    Other Names:
    • Pulmicort Flexhaler
    • Flovent Diskus
    • QVAR
  • Drug: Budesonide, Beclomethasone, Fluticasone
    Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID
    Other Names:
    • Pulmicort Flexhaler
    • QVAR
    • Flovent Diskus
  • Drug: Beclomethasone, Fluticasone, Budesonide
    Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID
    Other Names:
    • QVAR
    • Flovent Diskus
    • Pulmicort Flexhaler
  • Drug: Beclomethasone, Budesonide, Fluticasone
    Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID
    Other Names:
    • QVAR
    • Pulmicort Flexhaler
    • flovent Diskus
  • Experimental: 1 Treatment Sequence, FPQ
    Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR
    Intervention: Drug: Fluticasone, Budesonide, Beclomethasone
  • Experimental: 2 Treatment Sequence, FQP
    Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort
    Intervention: Drug: Fluticasone, Beclomethasone, Budesonide
  • Experimental: 3 Treatment Sequence, PFQ
    Period 2 Pulmicort Period 4 Flovent Period 6 QVAR
    Intervention: Drug: Budesonide, Fluticasone, Beclomethasone
  • Experimental: 4-Treatment Sequence, PQF
    Period 2 Pulmicort Period 4 QVAR Period 6 Flovent
    Intervention: Drug: Budesonide, Beclomethasone, Fluticasone
  • Experimental: 5 Treatment Sequence, QFP
    Period 2 QVAR Period 4 Flovent Period 6 Pulmicort
    Intervention: Drug: Beclomethasone, Fluticasone, Budesonide
  • Experimental: 6 Treatment Sequence, QPF
    Period 2 QVAR Period 4 Pulmicort Period 6 Flovent
    Intervention: Drug: Beclomethasone, Budesonide, Fluticasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Both
6 Years to 11 Years
Yes
Contact: Deborah A Gentile, MD 412-359-6645
Contact: Joseph Aracri, DO 412-922-5250
United States
 
NCT01520688
RC#5255
Yes
Deborah Gentile, West Penn Allegheny Health System
West Penn Allegheny Health System
Not Provided
Principal Investigator: Deborah A Gentile, MD Allegheny Singer Research Institute/Allegheny General Hospital
West Penn Allegheny Health System
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP