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.
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.
Ponce School of Medicine, Ponce 00732, Puerto Rico
Centro Neumologia Pediatrica, Hato Rey 00917, Puerto Rico
Southern California Research, Mission Viejo, California 92691, United States
Allergy and Asthma Medical Group, Walnut Creek, California 94598, United States
Clinical Trials of Orange County, Inc., Orange, California 92868, United States
Integrated Research Group, Riverside, California 92506, United States
Allergy Associates Medical Group, San Diego, California 92120, United States
California Allergy & Asthma, Palmdale, California 93551, United States
Allergy and Asthma Specialists, Huntington Beach, California 92647, United States
West Coast Clinical Trials, Long Beach, California 90806, United States
Center for Clinical Trials, LLC, Paramount, California 90723, United States
Pediatric Care Medical Group, Huntington Beach, California 92647, United States
Allergy & Asthma Care of Florida, Ocala, Florida 34471, United States
New Horizon's Health Research, Atlanta, Georgia 30309, United States
AeroAllergy Research Labs of Savanna, Inc, Savannah, Georgia 31406, United States
Sneeze, Wheeze and Itch Associates, Normal, Illinois 61761, United States
Family Allergy & Asthma Research Institute, Lousiville, Kentucky 40215, United States
Perez-Betancourt Medical Clinic, Metairie, Louisiana 70001, United States
NorthEast Medical Research Associates, North Dartmouth, Massachusetts 02747, United States
Clinical Research Institute, Plymouth, Minnesota 55441, United States
The Asthma and Allergy Center, Papillion, Nebraska 68046-4194, United States
Asthma and Allergy Associates, PC, Ithaca, New York 14850, United States
St.Elizabeth's Children's Health Center, Utica, New York 13502, United States
Regional Allergy and Asthma Consultants, Asheville, North Carolina 28805, United States
Allergy & Respiratory Center, Canton, Ohio 44718, United States
Dayton Clinical Research Center, Dayton, Ohio 45406, United States
Dr. Santiago Reyes, Oklahoma City, Oklahoma 73112, United States
Allergy and Asthma Clinical Research Center, Oklahoma City, Oklahoma 73120, United States
Allergy, Asthma & Dermatology Research Center, Lake Oswego, Oregon 97035, United States
Allergy and Asthma Research Groups, Eugene, Oregon 97401, United States
Allergy Associates Research Center, Portland, Oregon 97213, United States
Clinical Research Institute of Southern Oregon, PC, Medford, Oregon 97504, United States
Allergy & Clinical Immunology Associates, Pittsburg, Pennsylvania 15241, United States
The Allergy Asthma and Sinus Center, Knoxville, Tennessee 37922, United States
Pharmaceutical Research and Consulting, Inc., Dallas, Texas 75231, United States
Allergy and Asthma Associates, Houston, Texas 77054, United States
Pediatric Allergy/Immunology Assoc., Dallas, Texas 75230, United States
Virginia Adult & Pediatric Allergy & Asthma, Richmond, Virginia 23229, United States
Spokane Allergy and Asthma Clinical Research, Spokane, Washington 99204, United States
