Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children

November 19, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
440

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2004

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IXR-302-25-197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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