Clinical trial NCT00094016: Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children
Official title: Safety and Efficacy Evaluation of Two Doses of HFA-Propelled Beclomethasone Dipropionate (QVAR) Versus Placebo by Breath Operated and Metered Dose Inhalers in Mild to Moderate Asthmatic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2004-10-11
Enrollment: 440
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in 1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal awakening and utilization of rescue medication per day also will be evaluated. In addition, an exploratory evaluation will assess the comparability of the two devices (i.e., QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels.


Eligibility criteria: Inclusion Criteria:

* Male or female children aged 5 through 11 years at the screening visit
* Documented clinical evidence of asthma (FEV1 = 65-90%)
* Ability to perform acceptable and reproducible spirometry per ATS guidelines
* Ability to perform PEF determinations
* Reversible bronchoconstriction as verified by \>12% increase in FEV1
* Otherwise healthy children with clinically-acceptable medical history, physical examination, vital signs and clinical laboratory parameters within the acceptable ranges for asthma patients
* The parent or guardian must be willing to give written informed consent as well as the patient assent and be able to adhere to the dose and visit schedule.

Exclusion Criteria:

* Patients who have used inhaled corticosteroids within 30 days prior to the screening visit.
* Allergy or sensitivity to beclomethasone dipropionate (BDP) or to other components of the formulations used in the CTM
* Patients demonstrating an increase or decrease in FEV1 \>20% between the screening and baseline visit.
* Patients who are unable to use a metered dose inhaler (MDI) without a spacer device.
* Patients requiring the use of \>12 puffs per day of albuterol for any 3 consecutive days between the screening and baseline visits.
* Patients with evidence of growth retardation
* Patients who have been treated with methotrexate, cyclosporin, gold or other cytotoxic agents for the control of asthma or for a concurrent condition within the last 3 months.
* Patients who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for rhinitis.
* Patients with evidence (on physical exam) of oropharyngeal candidiasis.
* Exposure to investigational drugs within 30 days prior to the screening visit
* Require continuous treatment with beta blockers MAO inhibitors, tricyclic antidepressants, anticholinergics, inhaled nedocromil or cromolyn, or nebulized therapy (excluding sponsor provided albuterol MDI)
* Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
* Treatment at any time for life-threatening asthmatic episodes (e.g., episodes requiring intubation and/or associated with the development of hypercapnia, hypoxia and seizures, etc.)
* Patients that have received any of the following treatments or met any of the following conditions within six weeks prior to the screening visit:

  * Oral or injectable corticosteroids
  * an upper respiratory tract infection and/or sinusitis associated with exacerbation of asthmatic symptoms
  * emergency room treatment or hospitalization for asthmatic symptoms.
* History and/or presence of any non-asthmatic acute or chronic lung disease, including but not limited to bronchitis (within the previous 6 months), emphysema, active tuberculosis, bronchiectasis or cystic fibrosis.
* Presence of any clinically-significant cardiovascular disease (including cardiac arrhythmias and uncontrolled hypertension), clinically-significant hepatic, renal, or endocrine dysfunction, stroke, uncontrolled diabetes, hyperthyroidism, convulsive disorders, neoplastic disease other than basal cell carcinoma, and significant psychiatric disease.
* History of glaucoma or cataracts
* Presence of systemic fungal, bacterial, viral or parasitic infections and/or ocular herpes simplex
* Unlikely to be compliant, take study medication as directed, complete the diary cards, or attend scheduled clinic visits as required.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialists
state: California
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group
state: California
city: Long Beach
country: United States
facility: West Coast Clinical Trials
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: Orange
country: United States
facility: Clinical Trials of Orange County, Inc.
state: California
city: Palmdale
country: United States
facility: California Allergy & Asthma
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Riverside
country: United States
facility: Integrated Research Group
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Medical Group
state: California
city: Ocala
country: United States
facility: Allergy & Asthma Care of Florida
state: Florida
city: Atlanta
country: United States
facility: New Horizon's Health Research
state: Georgia
city: Savannah
country: United States
facility: AeroAllergy Research Labs of Savanna, Inc
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze and Itch Associates
state: Illinois
city: Louisville
country: United States
facility: Family Allergy & Asthma Research Institute
state: Kentucky
city: Metairie
country: United States
facility: Perez-Betancourt Medical Clinic
state: Louisiana
city: North Dartmouth
country: United States
facility: NorthEast Medical Research Associates
state: Massachusetts
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Papillion
country: United States
facility: The Asthma and Allergy Center
state: Nebraska
city: Ithaca
country: United States
facility: Asthma and Allergy Associates, PC
state: New York
city: Utica
country: United States
facility: St.Elizabeth's Children's Health Center
state: New York
city: Asheville
country: United States
facility: Regional Allergy and Asthma Consultants
state: North Carolina
city: Canton
country: United States
facility: Allergy & Respiratory Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Dr. Santiago Reyes
state: Oklahoma
city: Oklahoma City
country: United States
facility: Allergy and Asthma Clinical Research Center
state: Oklahoma
city: Eugene
country: United States
facility: Allergy and Asthma Research Groups
state: Oregon
city: Lake Oswego
country: United States
facility: Allergy, Asthma & Dermatology Research Center
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Portland
country: United States
facility: Allergy Associates Research Center
state: Oregon
city: Pittsburgh
country: United States
facility: Allergy & Clinical Immunology Associates
state: Pennsylvania
city: Knoxville
country: United States
facility: The Allergy Asthma and Sinus Center
state: Tennessee
city: Dallas
country: United States
facility: Pediatric Allergy/Immunology Assoc.
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research and Consulting, Inc.
state: Texas
city: Houston
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Richmond
country: United States
facility: Virginia Adult & Pediatric Allergy & Asthma
state: Virginia
city: Spokane
country: United States
facility: Spokane Allergy and Asthma Clinical Research
state: Washington
city: Hato Rey
country: Puerto Rico
facility: Centro Neumologia Pediatrica
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine
Study officials:
References: