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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Fluticasone, Budesonide, Beclomethasone

Fluticasone, Beclomethasone, Budesonide

Budesonide, Fluticasone, Beclomethasone

Budesonide, Beclomethasone, Fluticasone

Beclomethasone, Fluticasone, Budesonide

Beclomethasone, Budesonide, Fluticasone

About this trial

This is an interventional treatment trial for Asthma focused on measuring Mild persistent or mild intermittent asthma

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age).
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.
All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history.
All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination.
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.
Subjects must be willing to comply with study requirements.

Exclusion Criteria:

Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines.
Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days.
Subjects will be excluded if they had more than one burst of systemic steroids within the past year.
Subjects will be excluded if their baseline FEV1 is < 80% predicted.
Subjects will be excluded if they have any other serious systemic disease other than asthma.
Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days
Subjects will be excluded if they have a history of allergy to any of the study medications, milk protein or lactose.
Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles.
Subjects will be excluded if they have any history of tuberculosis of the respiratory tract.
Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections.
Subjects will be excluded if they have any history of herpes simplex infection of the eye.
Subjects will be excluded if they have taken any immunosuppressive drugs within the past 2 months.
Subjects will be excluded if they have any history of Churg-Strauss syndrome or other eosinophilic disorders.
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.
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.

Sites / Locations

Pediatric Alliance-Greentree Division
Allegheny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

1 Treatment Sequence, FPQ

2 Treatment Sequence, FQP

3 Treatment Sequence, PFQ

4-Treatment Sequence, PQF

5 Treatment Sequence, QFP

6 Treatment Sequence, QPF

Arm Description

Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR

Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort

Period 2 Pulmicort Period 4 Flovent Period 6 QVAR

Period 2 Pulmicort Period 4 QVAR Period 6 Flovent

Period 2 QVAR Period 4 Flovent Period 6 Pulmicort

Period 2 QVAR Period 4 Pulmicort Period 6 Flovent

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01520688

First Posted

January 24, 2012

Last Updated

October 30, 2020

Sponsor

West Penn Allegheny Health System

1. Study Identification

Unique Protocol Identification Number

NCT01520688

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West Penn Allegheny Health System

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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: 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. 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: 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. 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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Mild persistent or mild intermittent asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 Treatment Sequence, FPQ

Arm Type

Experimental

Arm Description

Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR

Arm Title

2 Treatment Sequence, FQP

Arm Type

Experimental

Arm Description

Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort

Arm Title

3 Treatment Sequence, PFQ

Arm Type

Experimental

Arm Description

Period 2 Pulmicort Period 4 Flovent Period 6 QVAR

Arm Title

4-Treatment Sequence, PQF

Arm Type

Experimental

Arm Description

Period 2 Pulmicort Period 4 QVAR Period 6 Flovent

Arm Title

5 Treatment Sequence, QFP

Arm Type

Experimental

Arm Description

Period 2 QVAR Period 4 Flovent Period 6 Pulmicort

Arm Title

6 Treatment Sequence, QPF

Arm Type

Experimental

Arm Description

Period 2 QVAR Period 4 Pulmicort Period 6 Flovent

Intervention Type

Drug

Intervention Name(s)

Fluticasone, Budesonide, Beclomethasone

Other Intervention Name(s)

Flovent Diskus, Pulmicort Flexhaler, QVAR

Intervention Description

Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid

Intervention Type

Drug

Intervention Name(s)

Fluticasone, Beclomethasone, Budesonide

Other Intervention Name(s)

Flovent Diskus, Pulmicort Flexhaler, QVAR

Intervention Description

Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID

Intervention Type

Drug

Intervention Name(s)

Budesonide, Fluticasone, Beclomethasone

Other Intervention Name(s)

Pulmicort Flexhaler, Flovent Diskus, QVAR

Intervention Description

Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID

Intervention Type

Drug

Intervention Name(s)

Budesonide, Beclomethasone, Fluticasone

Other Intervention Name(s)

Pulmicort Flexhaler, QVAR, Flovent Diskus

Intervention Description

Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID

Intervention Type

Drug

Intervention Name(s)

Beclomethasone, Fluticasone, Budesonide

Other Intervention Name(s)

QVAR, Flovent Diskus, Pulmicort Flexhaler

Intervention Description

Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID

Intervention Type

Drug

Intervention Name(s)

Beclomethasone, Budesonide, Fluticasone

Other Intervention Name(s)

QVAR, Pulmicort Flexhaler, flovent Diskus

Intervention Description

Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID

Primary Outcome Measure Information:

Title

Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.

Description

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.

Time Frame

1 yr

Secondary Outcome Measure Information:

Title

Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID.

Description

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.

Time Frame

1 yr

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects will include females (6 to 9 years of age) and males (6 to 11 years of age). 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. All subjects must have a height within normal limits (5th to 95th percentile) and no history of abnormal growth as assessed by medical history. All subjects must be pre-pubertal (Tanner Stage 1 Sexual Maturity) as assessed by physical examination. 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. Subjects must be willing to comply with study requirements. Exclusion Criteria: Subjects will be excluded if they have asthma greater than mild persistent severity as defined by NHLBI guidelines. Subjects will be excluded if they used any systemic or nasal steroids within the past 60 days. Subjects will be excluded if they had more than one burst of systemic steroids within the past year. Subjects will be excluded if their baseline FEV1 is < 80% predicted. Subjects will be excluded if they have any other serious systemic disease other than asthma. Subjects will be excluded if they have taken any medication known to affect growth i.e. ADHD medications within the past 60 days Subjects will be excluded if they have a history of allergy to any of the study medications, milk protein or lactose. Subjects will be excluded if they have active chickenpox or measles or recent exposure to chickenpox or measles. Subjects will be excluded if they have any history of tuberculosis of the respiratory tract. Subjects will be excluded if they have any active fungal, bacterial, viral or parasitic infections. Subjects will be excluded if they have any history of herpes simplex infection of the eye. Subjects will be excluded if they have taken any immunosuppressive drugs within the past 2 months. Subjects will be excluded if they have any history of Churg-Strauss syndrome or other eosinophilic disorders. 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah A Gentile, MD

Organizational Affiliation

Allegheny Singer Research Institute/Allegheny General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pediatric Alliance-Greentree Division

City

Green Tree

State/Province

Pennsylvania

ZIP/Postal Code

15220

Country

United States

Facility Name

Allegheny General Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

12. IPD Sharing Statement

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

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