Status:
COMPLETED
Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Conditions:
Asthma
Eligibility:
All Genders
5-11 years
Phase:
PHASE3
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) re...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 31 2004
Trial Type :
INTERVENTIONAL
End Date :
June 30 2006
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT00094016
Start Date
October 31 2004
End Date
June 30 2006
Last Update
November 23 2021
Active Locations (39)
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1
Allergy and Asthma Specialists
Huntington Beach, California, United States, 92647
2
Pediatric Care Medical Group
Huntington Beach, California, United States, 92647
3
West Coast Clinical Trials
Long Beach, California, United States, 90806
4
Southern California Research
Mission Viejo, California, United States, 92691