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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01520688
• Other study ID #: RC#5255
• Status: Completed
• Phase: Phase 4
• Start date: February 2012
• Est. completion date: February 2016

Study information

• Verified date: October 2020
• Source: West Penn Allegheny Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone, Budesonide, Beclomethasone
Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid
• Fluticasone, Beclomethasone, Budesonide
Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID
• Budesonide, Fluticasone, Beclomethasone
Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID
• Budesonide, Beclomethasone, Fluticasone
Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID
• Beclomethasone, Fluticasone, Budesonide
Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID
• Beclomethasone, Budesonide, Fluticasone
Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID

Locations

Country	Name	City	State
United States	Pediatric Alliance-Greentree Division	Green Tree	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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