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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Fluticasone, Budesonide, Beclomethasone; Drug: Fluticasone, Beclomethasone, Budesonide; Drug: Budesonide, Fluticasone, Beclomethasone; Drug: Budesonide, Beclomethasone, Fluticasone; Drug: Beclomethasone, Fluticasone, Budesonide; Drug: Beclomethasone, Budesonide, Fluticasone

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Green Tree, Pennsylvania, United States, 15220
      • Pediatric Alliance-Greentree Division
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: QVAR; Flovent Diskus; Pulmicort Flexhaler
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: QVAR; Flovent Diskus; Pulmicort Flexhaler
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: QVAR; Flovent Diskus; Pulmicort Flexhaler
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: QVAR; Flovent Diskus; Pulmicort Flexhaler
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.	Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.	1 yr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID.	Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma during treatment with Flovent Discus 100 mcg BID or QVAR 80 mcg BID.	1 yr

Collaborators and Investigators

• Sponsor: West Penn Allegheny Health System
• Investigators: Principal Investigator: Deborah A Gentile, MD, Allegheny Singer Research Institute/Allegheny General Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: January 24, 2012
• First Submitted That Met QC Criteria: January 26, 2012
• First Posted (Estimate): January 30, 2012

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Mild persistent or mild intermittent asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Budesonide; Fluticasone; Xhance; Beclomethasone
• Other Study ID Numbers: RC#5255