Evaluation of Two Doses of QVAR Versus Placebo by Breath Operated and Metered Dose Inhalers in Moderate Asthmatic Adolescents and Adults on a Stable Regimen of Inhaled Corticosteroids

Teva Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: beclomethasone dipropionate (QVAR)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00109668

IXR-301-4-197

Details and patient eligibility

About

QVAR in a standard press and breath inhaler (QVAR-MDI) has been approved by the Food and Drug Administration (FDA) for use in the United States. The purpose of this study is to determine the level of asthma control when comparing the safety and effectiveness of QVAR in two different devices, a metered dose inhaler (MDI) and a breath operated inhaler (BOI).

Full description

This investigation is a multicenter, randomized, placebo and active controlled, double-blind, double-dummy, parallel-group study to evaluate the safety and efficacy of two doses of QVAR-BOI in adolescents and adults.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or non-pregnant, non-nursing female at least 12 years of age at the screening visit. NOTE: Females of childbearing potential may be included if they are practicing an acceptable method of contraception for at least 2 months and have a negative urine pregnancy test at the screening visit.
Asthma (FEV1 60-85% predicted)
Ability to perform acceptable and reproducible spirometry
Ability to perform PEF determinations
Reversible bronchoconstriction as verified by a greater than or equal to 12% increase in FEV1 following inhalation of albuterol. Historical reversibility will be allowed
Patients must be on a stable regimen of daily-inhaled corticosteroids at low to medium doses for at least 30 days prior to screening.
Otherwise healthy individuals with clinically-acceptable medical history, physical examination, vital signs, 12 lead ECG, and clinical laboratory parameters within the acceptable ranges for asthma patients.
Non-smoker for at least one year prior to the screening visit and maximum smoking history of ten-pack years
The patient must be willing to give written informed consent and be able to adhere to the dose and visit schedules. If applicable, parent or guardian must also provide consent.

Exclusion criteria

Allergy or sensitivity to BDP (beclomethasone dipropionate) 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 requiring the use of >12 puffs per day of albuterol for any 3 consecutive days between the screening and baseline visits.
Patients who are unable to use an MDI without a spacer device. (Use of spacers is prohibited during the course of the study.)
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 of oropharyngeal candidiasis.
Exposure to investigational drugs within 30 days prior to the screening visit
Require continuous treatment with beta blockers (administered by any route), MAO inhibitors, leukotriene modifiers, tricyclic antidepressants, anticholinergics, inhaled nedocromil or cromolyn, or nebulized therapy (excluding sponsor provided albuterol MDI) following the screening visit.
Patients who 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
Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
Treatment at any time for life-threatening asthmatic episodes
History or presence of any non-asthmatic acute or chronic lung disease
History of glaucoma, ocular hypertension or cataracts
Presence of systemic fungal, bacterial, viral or parasitic infections and/or ocular herpes simplex
Known or suspected substance abuse (e.g., alcohol, marijuana, etc.)
Patients who are known to be HIV positive
Unlikely to be compliant, take study medication as directed, complete the diary cards, or attend scheduled clinic visits as required.