AsthmaPhase 3NCT00094016
Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children
A Phase 3 study testing beclomethasone dipropionate in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 39 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- beclomethasone dipropionate
- How many people
- 440 participants
- Where
- 39 sitesin 2 countries
- Study dates
- 31 Oct 2004to 30 Jun 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
39 sites in 2 countries.
39 sites in 2 countries
United States37 sites
Regional Allergy and Asthma Consultants
Asheville, North Carolina, 28805
New Horizon's Health Research
Atlanta, Georgia, 30309
Allergy & Respiratory Center
Canton, Ohio, 44718
Pediatric Allergy/Immunology Assoc.
Dallas, Texas, 75230
Pharmaceutical Research and Consulting, Inc.
Dallas, Texas, 75231
Dayton Clinical Research Center
Dayton, Ohio, 45406
Allergy and Asthma Research Groups
Eugene, Oregon, 97401
Allergy and Asthma Associates
Houston, Texas, 77054
Allergy and Asthma Specialists
Huntington Beach, California, 92647
Pediatric Care Medical Group
Huntington Beach, California, 92647
Asthma and Allergy Associates, PC
Ithaca, New York, 14850
The Allergy Asthma and Sinus Center
Knoxville, Tennessee, 37922
Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, 97035
West Coast Clinical Trials
Long Beach, California, 90806
Family Allergy & Asthma Research Institute
Louisville, Kentucky, 40215
Clinical Research Institute of Southern Oregon, PC
Medford, Oregon, 97504
Perez-Betancourt Medical Clinic
Metairie, Louisiana, 70001
Southern California Research
Mission Viejo, California, 92691
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761
NorthEast Medical Research Associates
North Dartmouth, Massachusetts, 02747
Allergy & Asthma Care of Florida
Ocala, Florida, 34471
Dr. Santiago Reyes
Oklahoma City, Oklahoma, 73112
Allergy and Asthma Clinical Research Center
Oklahoma City, Oklahoma, 73120
Clinical Trials of Orange County, Inc.
Orange, California, 92868
California Allergy & Asthma
Palmdale, California, 93551
The Asthma and Allergy Center
Papillion, Nebraska, 68046-4194
Center for Clinical Trials, LLC
Paramount, California, 90723
Allergy & Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Clinical Research Institute
Plymouth, Minnesota, 55441
Allergy Associates Research Center
Portland, Oregon, 97213
Virginia Adult & Pediatric Allergy & Asthma
Richmond, Virginia, 23229
Integrated Research Group
Riverside, California, 92506
Allergy Associates Medical Group
San Diego, California, 92120
AeroAllergy Research Labs of Savanna, Inc
Savannah, Georgia, 31406
Spokane Allergy and Asthma Clinical Research
Spokane, Washington, 99204
St.Elizabeth's Children's Health Center
Utica, New York, 13502
Allergy and Asthma Medical Group
Walnut Creek, California, 94598
Puerto Rico2 sites
Centro Neumologia Pediatrica
Hato Rey, 00917
Ponce School of Medicine
Ponce, 00732
About this study
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
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.
- Conditions
- Asthma
- Being tested
- beclomethasone dipropionate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasone dipropionateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2004 (estimated)
- Study start31 Oct 2004
- Primary completion30 Jun 2006
- Study completion30 Jun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 440 participants
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094016
- Sponsor's protocol ID
- IXR-302-25-197
- Status last verified
- Nov 2021
- First submitted
- 8 Oct 2004
- Last updated
- 23 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00094016
- Acronym / sponsor ID
- IXR-302-25-197
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2004 (actual)
- Primary completion
- 30 Jun 2006 (actual)
- Study completion
- 30 Jun 2006 (actual)
- First posted
- 11 Oct 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beclomethasone dipropionate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
39 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing beclomethasone dipropionate in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 39 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.