Bronchial AsthmaPhase 1/2NCT00411567
A Study to Assess the Efficacy of Inhaled Corticosteroid (ICS) Therapy in Moderate-Severe Bronchial Asthma
A Phase 1/2 study testing inhaled corticosteroid therapy in people with Bronchial Asthma, run by Novartis at 1 site in Germany.
Trial summary
The purpose of this study is to investigate/assess the treatment of moderate to severe asthmatics with inhaled corticosteroid. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- inhaled corticosteroid therapy
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2006to not given
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or female moderate to severe asthmatic patients, from 18-75 years of age.
- Moderate to severe asthma, according to the GINA guidelines, for at least one year with no exacerbations requiring hospitalization and/or oral steroids within the previous three months.
- No concomitant lung disease or significant medical conditions
- Fluticasone propionate 500mcg daily or greater, or equivalent (Mometsaone 800 mcg, triamcinolone 2000 mcg, Flunisolide 2000 mcg, Budesonide DPI 800 mcg, Beclomathasone HFA 500 mcg, Beclomethasone CFC 1000 mcg, Forced expiratory volume in 1 second (FEV1) at screening will be ≥ 70% of the normal predicted.
- Evidence of asthma, demonstrated by one of the following: Historical evidence confirmed by their treating physician or Demonstration of ≥ 12% reversibility of FEV1 using a standard dose of salbutamol (up to 400 µg) within 30 minutes.
- Female subjects of child bearing potential must be using two forms of contraception or postmenopausal women must have no regular menstrual bleeding for at least 2 years prior to inclusion.
- Body Mass Index between 18 and 30. Body weight should be less than 100 kg.
Who cannot join
- Smokers
- Concomitant medications: Except for short- and long-acting β-agonists and medication which may be required to treat adverse events, all other medications, other than study drug should be avoided from screening until all of the study completion evaluations have been conducted. Paracetamol is acceptable.
- Medical conditions: history of clinically significant drug allergy; any significant medical condition. For example, a history of any pulmonary disorder other than asthma.
- Any surgical or medical condition which might significantly alter the distribution, metabolism or excretion of the drug.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or longer if required by local regulation.
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- Significant illness within the two weeks prior to dosing.
- A past personal or close family medical history of clinically significant cardiac abnormalities
- History of history of fainting, orthostatic hypotension, sinus arrhythmia, etc.
- A known hypersensitivity to Fluticasone propionate or drugs similar to Fluticasone propionate.
- History of immunocompromise, including a positive HIV test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of drug or alcohol abuse within the 12 months prior to dosing
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Assess the Utility of Measuring Markers of Inflammation, to Detect Transition From Optimal to Sub-Optimal Inhaled Corticosteroid Therapy in Moderate-Severe Bronchial Asthma
The purpose of this study is to investigate/assess the treatment of moderate to severe asthmatics with inhaled corticosteroid.
- Conditions
- Bronchial Asthma
- Being tested
- inhaled corticosteroid therapy
- Keywords
- markers, inflammation, optimal, sub-optimal, corticosteroid, bronchial asthma
- Medical subject headings
- Asthma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled corticosteroid therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory parameters in response to a decrease in ICS compared to no change in therapy after 2 and 4 weeks
Secondary outcomes (2)
Parameter/combination of parameters most sensitive to the ICS reduction
Collection of relative data to assess sample size calculations for subsequent studies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study startJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Principal investigator, Investigator site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411567
- Sponsor's protocol ID
- CQAE397A2202
- Status last verified
- Jun 2007
- First submitted
- 13 Dec 2006
- Last updated
- 22 Jun 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Assess the Utility of Measuring Markers of Inflammation, to Detect Transition From Optimal to Sub-Optimal Inhaled Corticosteroid Therapy in Moderate-Severe Bronchial Asthma
- ClinicalTrials.gov ID
- NCT00411567
- Acronym / sponsor ID
- CQAE397A2202
- Conditions
- Bronchial Asthma
- Keywords
- markers, inflammation, optimal, sub-optimal, corticosteroid, bronchial asthma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- First posted
- 14 Dec 2006 (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 purpose of this study is to investigate/assess the treatment of moderate to severe asthmatics with inhaled corticosteroid.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and/or female moderate to severe asthmatic patients, from 18-75 years of age.
- Moderate to severe asthma, according to the GINA guidelines, for at least one year with no exacerbations requiring hospitalization and/or oral steroids within the previous three months.
- No concomitant lung disease or significant medical conditions
- Fluticasone propionate 500mcg daily or greater, or equivalent (Mometsaone 800 mcg, triamcinolone 2000 mcg, Flunisolide 2000 mcg, Budesonide DPI 800 mcg, Beclomathasone HFA 500 mcg, Beclomethasone CFC 1000 mcg, Forced expiratory volume in 1 second (FEV1) at screening will be ≥ 70% of the normal predicted.
- Evidence of asthma, demonstrated by one of the following: Historical evidence confirmed by their treating physician or Demonstration of ≥ 12% reversibility of FEV1 using a standard dose of salbutamol (up to 400 µg) within 30 minutes.
Key exclusion criteria (14 listed)
- Smokers
- Concomitant medications: Except for short- and long-acting β-agonists and medication which may be required to treat adverse events, all other medications, other than study drug should be avoided from screening until all of the study completion evaluations have been conducted. Paracetamol is acceptable.
- Medical conditions: history of clinically significant drug allergy; any significant medical condition. For example, a history of any pulmonary disorder other than asthma.
- Any surgical or medical condition which might significantly alter the distribution, metabolism or excretion of the drug.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
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 |
|---|---|---|
| inhaled corticosteroid therapy | Drug | – |
Primary outcome
Change in inflammatory parameters in response to a decrease in ICS compared to no change in therapy after 2 and 4 weeks
2 secondary outcomes
Parameter/combination of parameters most sensitive to the ICS reduction
Collection of relative data to assess sample size calculations for subsequent studies
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 22 Jun 2007.
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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.
Novartis principal investigator
Investigator site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing inhaled corticosteroid therapy in people with Bronchial Asthma, run by Novartis at 1 site in Germany.
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 14 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 22 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Change in inflammatory parameters in response to a decrease in ICS compared to no change in therapy after 2 and 4 weeks. It is what the study was designed to measure, not a finding.
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 22 Jun 2007.