AsthmaPhase 3NCT00109668
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
A Phase 3 study testing beclomethasone dipropionate (QVAR) in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 32 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- beclomethasone dipropionate (QVAR)
- How many people
- 415 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 31 Jul 2004to 30 Sep 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States31 sites
Dr. Emory Robinette
Abingdon, Virginia, 24210
Regional Allergy and Asthma Consultants
Asheville, North Carolina, 28805
Belligham Asthma and Allergy
Bellingham, Washington, 98225
Alabama Allergy and Asthma
Birmingham, Alabama, 35209
Boulder Medical Center
Boulder, Colorado, 80304
National Allergy and Asthma and Urticaria Centers of Charleston, PA
Charleston, South Carolina, 29407
Pulmonary Consultants of North Idaho
Coeur d'Alene, Idaho, 83814
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907
Colorado Allergy and Asthma Center
Denver, Colorado, 80230
Allergy and Asthma Associates
Houston, Texas, 77054
Allergy and Asthma Specialists
Huntington Beach, California, 92647
Bendel Medical Research
Lafayette, Louisiana, 70503
Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, 97035
West Coast Clinical Trials
Long Beach, California, 90806
Allergy Research Foundation
Los Angeles, California, 90025
UCLA David Geffen School of Medcine
Los Angeles, California, 90095
Family Allergy and Asthma Research Center
Louisville, Kentucky, 40215
Morgantown Pulmonary Associates
Morgantown, West Virginia, 26505
Sneeze, Wheeze and Itch Associates
Normal, Illinois, 61761
Northeast Medical Research Associates
North Dartmouth, Massachusetts, 02747
Allergy, Asthma & Clinical Research Center
Oklahoma City, Oklahoma, 73120
Clinical Trials of Orange County, Inc.
Orange, California, 92868
Allergy Associates Research Center
Portland, Oregon, 97213
Allergy Associates Medical Group
San Diego, California, 92120
Asthma and Allergy Research Center
Sarasota, Florida, 34233
Aero Allergy Research Labs of Savannah, Inc
Savannah, Georgia, 31406
The Clinical Research Center
St Louis, Missouri, 63141
Pulmonary Consultants
Tacoma, Washington, 98405
Allergy and Asthma DTC
Tallahassee, Florida, 32308
Dr. Alan Kaufman
The Bronx, New York, 10465
Allergy and Asthma Medical Group
Walnut Creek, California, 94598
About this study
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).
Read the detailed 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.
- Conditions
- Asthma
- Being tested
- beclomethasone dipropionate (QVAR)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasone dipropionate (QVAR)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2005 (estimated)
- Study start31 Jul 2004
- Primary completion30 Sep 2006
- Study completion30 Sep 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
- 415 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
- NCT00109668
- Sponsor's protocol ID
- IXR-301-4-197
- Status last verified
- Dec 2021
- First submitted
- 2 May 2005
- Last updated
- 8 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00109668
- Acronym / sponsor ID
- IXR-301-4-197
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2004 (actual)
- Primary completion
- 30 Sep 2006 (actual)
- Study completion
- 30 Sep 2006 (actual)
- First posted
- 3 May 2005 (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.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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.
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 (QVAR) | 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 8 Dec 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.
32 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 (QVAR) in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 32 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 9 inclusion and 18 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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 8 Dec 2021.