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

NCT01520688 | Completed Phase 4 Results DMC

• 1 other identifier: RC#5255
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

Mild persistent or mild intermittent asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 yr

Study Arms (6)

1 Treatment Sequence, FPQ

EXPERIMENTAL

Period 2 Flovent Diskus Period 4 Pulmicort Flexhaler Period 6 QVAR

Drug: Fluticasone, Budesonide, Beclomethasone

2 Treatment Sequence, FQP

EXPERIMENTAL

Period 2 Flovent Diskus Period 4 QVAR Period 6 Pulmicort

Drug: Fluticasone, Beclomethasone, Budesonide

3 Treatment Sequence, PFQ

EXPERIMENTAL

Period 2 Pulmicort Period 4 Flovent Period 6 QVAR

Drug: Budesonide, Fluticasone, Beclomethasone

4-Treatment Sequence, PQF

EXPERIMENTAL

Period 2 Pulmicort Period 4 QVAR Period 6 Flovent

Drug: Budesonide, Beclomethasone, Fluticasone

5 Treatment Sequence, QFP

EXPERIMENTAL

Period 2 QVAR Period 4 Flovent Period 6 Pulmicort

Drug: Beclomethasone, Fluticasone, Budesonide

6 Treatment Sequence, QPF

EXPERIMENTAL

Period 2 QVAR Period 4 Pulmicort Period 6 Flovent

Drug: Beclomethasone, Budesonide, Fluticasone

Interventions

Fluticasone, Budesonide, Beclomethasone DRUG

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

Also known as: Flovent Diskus, Pulmicort Flexhaler, QVAR

1 Treatment Sequence, FPQ

Fluticasone, Beclomethasone, Budesonide DRUG

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

Also known as: Flovent Diskus, Pulmicort Flexhaler, QVAR

2 Treatment Sequence, FQP

Budesonide, Fluticasone, Beclomethasone DRUG

Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID

Also known as: Pulmicort Flexhaler, Flovent Diskus, QVAR

3 Treatment Sequence, PFQ

Budesonide, Beclomethasone, Fluticasone DRUG

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

Also known as: Pulmicort Flexhaler, QVAR, Flovent Diskus

4-Treatment Sequence, PQF

Beclomethasone, Fluticasone, Budesonide DRUG

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

Also known as: QVAR, Flovent Diskus, Pulmicort Flexhaler

5 Treatment Sequence, QFP

Beclomethasone, Budesonide, Fluticasone DRUG

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

Also known as: QVAR, Pulmicort Flexhaler, flovent Diskus

6 Treatment Sequence, QPF

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Penn Allegheny Health System: lead

Study Sites (2)

Pediatric Alliance-Greentree Division

Green Tree, Pennsylvania, 15220, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Budesonide; Beclomethasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Pregnadienetriols; Pregnadienes; Steroids, Chlorinated

Results Point of Contact

• Title: Deborah Gentile, MD
• Organization: Allegheny Health Network

dgentile@ahn.org

412-359-4099

Study Officials

• Deborah A Gentile, MD

  Allegheny Singer Research Institute/Allegheny General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: January 30, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 18, 2020
• Results First Posted: October 12, 2020

Record last verified: 2020-10

Locations

US (2)