Lung DiseasePhase 4NCT00139152
Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair
A Phase 4 study testing Xolair in people with Lung Disease, run by Creighton University at 2 sites in United States.
Trial summary
The purpose of this study is to study the effects of Xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Lung Disease
- What is being tested?
- Xolair
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2005to Dec 2009
- Phase
- Phase 4
- 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
- On medium to high dose inhaled corticosteroids either with or without a long acting beta agonist
- Baseline IgE 30-700 IU/mL
- Exhaled nitric oxide greater than 13 ppb
- Positive skin test to at least one of the following perennial allergens: cat, dog, dust mite, cockroach
- Stable asthma at the time of enrollment
Who cannot join
- Concurrent diseases/conditions, history of other diseases/conditions, with clinically significant uncontrolled systemic disease or a history of such disease (eg, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinological, or gastrointestinal disease) within previous 3 months
- Upper or lower respiratory tract infection within 6 weeks of screening visit
- Elevated IgE level other than atopy
- Known sensitivity to Xolair
- < 3 months of stable immunotherapy
- Smokers
Show all 12Show fewer
- Pregnant/nursing women
- Women of childbearing potential who are not practicing medically approved contraceptive methods (eg, oral, subcutaneous, mechanical, or surgical contraception) including abstinence
- Patients who currently hav diagnosed cancer, are currently being investigated for possible cancer or who have any history of cancer
- Known sensitivity to study drug or class of study drugs
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Use of any other investigational agent in the last 30 days.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Albany Medical College
Albany, New York, 12208
Creighton University Division of Allergy & Immunology
Omaha, Nebraska, 68131
About this study
Official title: Exhaled Breath Condensate and Nitric Oxide: Non-invasive Evaluation of Lung Disease After Treatment With Xolair
The purpose of this study is to study the effects of Xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma.
Read the detailed description
Traditional methods of sampling secretions from the lower respiratory tract include sputum collection, sputum induction, and bronchoscopy with bronchoalveolar lavage. They cannot be repeated within a short period of time because of their invasiveness, and because the procedures themselves may include an inflammatory response. The need to monitor inflammation in the lungs has led to the exploration of exhaled gases and condensates. Noninvasive monitoring may assist in differential diagnosis of pulmonary diseases, assessment of disease severity and response to treatment.
- Conditions
- Lung Disease
- Being tested
- Placebo, Xolair
- Keywords
- moderate to severe allergic asthma
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Normal Saline
Saline, Sub-Cuteanous (SQ)
XolairDrug
Also called omalizumab, rhumabE25
Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline placebo Receives: Drug: Placebo |
| Xolair | Experimental | Xolair treatment Receives: Drug: Xolair |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of Xolair on exhaled nitric oxide and leukotriene levels obtained from exhaled breath condensate in patients before and after four months of Xolair or placebo treatment.
Measured: post dose
Secondary outcomes (1)
To measure the levels of power of hydrogen (pH), nitrate/nitrite in exhaled breath condensate before and after four months treatment with Xolair and to compare these data to those obtained from the placebo asthmatic control group.
Measured: post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Robert G Townley, MD, Principal investigator, Creighton University Division of Allergy & ImmunologyMuhammad A Pasha, M.D., Principal investigator, Albany Medical CollegeDivision of Allergy, Asthma, & Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139152
- Sponsor's protocol ID
- Xolair ENO EBC Study
- Status last verified
- Jan 2014
- First submitted
- 29 Aug 2005
- Last updated
- 7 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Condensate and Nitric Oxide: Non-invasive Evaluation of Lung Disease After Treatment With Xolair
- ClinicalTrials.gov ID
- NCT00139152
- Acronym / sponsor ID
- Xolair ENO EBC Study
- Conditions
- Lung Disease
- Keywords
- moderate to severe allergic asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Sep 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 Aug 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.
The purpose of this study is to study the effects of Xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma.
Detailed description
Traditional methods of sampling secretions from the lower respiratory tract include sputum collection, sputum induction, and bronchoscopy with bronchoalveolar lavage. They cannot be repeated within a short period of time because of their invasiveness, and because the procedures themselves may include an inflammatory response. The need to monitor inflammation in the lungs has led to the exploration of exhaled gases and condensates. Noninvasive monitoring may assist in differential diagnosis of pulmonary diseases, assessment of disease severity and response to treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSaline placebo |
| Xolair | Experimental | Drug: XolairXolair treatment |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- On medium to high dose inhaled corticosteroids either with or without a long acting beta agonist
- Baseline IgE 30-700 IU/mL
- Exhaled nitric oxide greater than 13 ppb
- Positive skin test to at least one of the following perennial allergens: cat, dog, dust mite, cockroach
- Stable asthma at the time of enrollment
Key exclusion criteria (12 listed)
- Concurrent diseases/conditions, history of other diseases/conditions, with clinically significant uncontrolled systemic disease or a history of such disease (eg, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinological, or gastrointestinal disease) within previous 3 months
- Upper or lower respiratory tract infection within 6 weeks of screening visit
- Elevated IgE level other than atopy
- Known sensitivity to Xolair
- < 3 months of stable immunotherapy
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 |
|---|---|---|
| PlaceboAlso: Normal SalineSaline, Sub-Cuteanous (SQ) | Drug | Placebo |
| XolairAlso: omalizumab, rhumabE25Xolair, 0.016 mg/kg Immunoglobulions E (IgE) , SQ | Drug | Xolair |
Primary outcome
To assess the effect of Xolair on exhaled nitric oxide and leukotriene levels obtained from exhaled breath condensate in patients before and after four months of Xolair or placebo treatment.
Time frame: post dose
1 secondary outcome
To measure the levels of power of hydrogen (pH), nitrate/nitrite in exhaled breath condensate before and after four months treatment with Xolair and to compare these data to those obtained from the placebo asthmatic control group.
Time frame: post dose
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 7 Jan 2014.
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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.
Robert G Townley, MD principal investigator
Creighton University Division of Allergy & Immunology
Muhammad A Pasha, M.D. principal investigator
Albany Medical CollegeDivision of Allergy, Asthma, & Immunology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xolair in people with Lung Disease, run by Creighton University at 2 sites in United States.
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 5 inclusion and 12 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 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To assess the effect of Xolair on exhaled nitric oxide and leukotriene levels obtained from exhaled breath condensate in patients before and after four months of Xolair or placebo treatment. (time frame: post dose). 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 7 Jan 2014.