NCT01550471

Brief Summary

This study will provide the clinicians guidance on the safest combination of inhaled and nasal corticosteroids for children with mild asthma and allergic rhinitis respectively; however, one safety concern is that these products are independently known to have dose-related effects on short term and intermediate term growth. Knemometry is a non invasive technique for measuring short-term lower leg growth in children and is currently the method of choice in growth studies of short duration. Subjects will be seen on a weekly basis for 18 weeks and at each visit, lower leg length will be measured using knemometry.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

October 14, 2020

Completed
Last Updated

November 4, 2020

Status Verified

October 1, 2020

Enrollment Period

3.4 years

First QC Date

February 19, 2012

Results QC Date

December 20, 2016

Last Update Submit

October 12, 2020

Conditions

AsthmaAllergic Rhinitis

Keywords

Mild asthma and allergic rhinitis

Outcome Measures

Primary Outcomes (1)

  • The Effect of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Beconase AQ Nasal Spray & QVAR Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.

    To evaulate the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID on- short-term lower leg growth as measured by knemometry in children with mild asthma and allergic rhinitis.

    1 yr

Secondary Outcomes (1)

  • The Effects of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Placebo Nasal Spray & Placebo Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.

    1 yr

Study Arms (6)

1 Treatment Sequence-A and O, Q and B, P and P

EXPERIMENTAL

Period 2-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 4-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 6-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID

Drug: Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo

2 Treatment Sequence-A and O, P and P, Q and B

EXPERIMENTAL

Period 2-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 4-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 6-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID

Drug: Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase

3 Treatment Sequence-Q and B, A and O, P and P

EXPERIMENTAL

Period 2-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 4-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 6-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID

Drug: QVAR/Beconase, Alvesco/Omnaris, Placebo/Placebo

4 Treatment Sequence-Q and B, P and P, A and O

EXPERIMENTAL

Period 2-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 4-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 6-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD

Drug: QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris

5 Treatment Sequence-P and P, A and O, Q and B

EXPERIMENTAL

Period 2-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 4-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD Period 6-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID

Drug: Placebo/Placebo, Alvesco/Omnaris, QVAR/Beconase

6 Treatment Sequence-P and P, Q and B, A and O

EXPERIMENTAL

Period 2-Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID Period 4-QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Period 6-Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD

Drug: Placebo/Placebo, QVAR/Beconase, Alvesco/Omnaris

Interventions

Alvesco/Omnaris, QVAR/Beconase, Placebo/PlaceboDRUG

Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID

Also known as: Ciclesonide, Beclomethasone, Placebo
1 Treatment Sequence-A and O, Q and B, P and P
Alvesco/Omnaris, Placebo/Placebo, QVAR/BeconaseDRUG

Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID

Also known as: Ciclesonide, Placebo, Beclomethasone
2 Treatment Sequence-A and O, P and P, Q and B
QVAR/Beconase, Alvesco/Omnaris, Placebo/PlaceboDRUG

QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID

Also known as: Beclomethasone, Ciclesonide, Placebo
3 Treatment Sequence-Q and B, A and O, P and P
QVAR/Beconase, Placebo/Placebo, Alvesco/OmnarisDRUG

QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD

Also known as: Beclomethasone, Placebo, Ciclesonide
4 Treatment Sequence-Q and B, P and P, A and O
Placebo/Placebo, Alvesco/Omnaris, QVAR/BeconaseDRUG

Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID

Also known as: Placebo, Ciclesonide, Beclomethasone
5 Treatment Sequence-P and P, A and O, Q and B
Placebo/Placebo, QVAR/Beconase, Alvesco/OmnarisDRUG

Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD

Also known as: Placebo, Beclomethasone, Ciclesonide
6 Treatment Sequence-P and P, Q and B, A and O

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subjects will include females and males 6 to 15 years of age.
  • All subjects must have a history of physician diagnosed mild asthma and allergic rhinitis 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.
  • 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 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. 5. 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 7. Subjects will be excluded if they have a history of allergy to any of the study medications.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pediatric Alliance-Greentree Division

Green Tree, Pennsylvania, 15220, United States

Location

Alleghney General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

MeSH Terms

Conditions

AsthmaRhinitis, Allergic

Interventions

ciclesonideBeclomethasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Results Point of Contact

Title
Deborah Gentile, Principal Investigator
Organization
Allegheny Health Network
dgentile@wpahs.org
412-359-4099

Study Officials

  • Deborah A Gentile, MD

    Allegheny General Hospital/Allegheny Singer Research Institute

    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

February 19, 2012

First Posted

March 12, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 4, 2020

Results First Posted

October 14, 2020

Record last verified: 2020-10

Locations

US(2)