Pulmonary Disease, Chronic ObstructivePhase 2NCT00851370
Exploratory Study of Xolair in Chronic Obstructive Pulmonary Disease in Patients With Elevated IgE Levels
A Phase 2 study testing Omalizumab (Xolair) in people with Pulmonary Disease, Chronic Obstructive, run by National Jewish Health at 1 site in United States.
Trial summary
The objective is to conduct an exploratory study on the effect of Omalizumab on COPD patients with elevated IgE. Exploratory outcomes include to determine whether Omalizumab use: reduces exacerbations in COPD patients; or improves rescue medication use, decreases ICS use, modified Medical Research Council (MMRC)… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Omalizumab (Xolair)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Feb 2011
- Phase
- Phase 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoking-related COPD and aged between 40 and 70 yrs.
- Total IgE of 30-700 IU and a positive RAST or skin prick test result to one or more perennial environmental allergens (e.g. dust mite (Dermatophagoides farinae, Dermatophagoides pteronyssinus), cockroach, dog, or cat.)
- Any race or sex; women with childbearing potential are required to use an acceptable method for birth control and have a negative pregnancy test
- History of ≥2 exacerbations during 2 yrs previous to the enrollment date
- An exacerbation will be defined as an increase or new onset of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least 3 days requiring antibiotic or systemic steroid treatment. The severity of an exacerbation will be determined by the following:
- Mild: Home management, with or without contacting a health care provider, or unscheduled office visit
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- Moderate: Requiring a visit to an emergency department
- Severe: Requiring hospitalization
- Very Severe: Requiring intubation and medical ventilation
- Post-bronchodilator FEV1 30-64% of predicted; the first 5 subjects enrolled will be required to have post-bronchodilator FEV1 50-64%
- Post-bronchodilator FEV1/FVC < 0.7
- Smokers or ex-smokers with at least a 20 pack-year smoking history
- Able to communicate meaningfully with the study personnel and to understand and read fluently in English
- Written informed consent;
- BODE score 3-10.
Who cannot join
- History of Omalizumab use
- Evidence of illicit drug use or abuse of alcohol.
- Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
- Known sensitivity to study drug(s) or class of study drug(s)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
- Use of any other investigational agent in the last 30 days
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- Continuous treatment with oral corticosteroids
- Participating in another trial within 3 months prior to the beginning of the study
- Non-compliance in taking medications
- Planned for lung transplantation at the time of admission to the study or expected to be transplanted within 3 yrs
- Alpha-1-antitrypsin deficiency
- Cystic fibrosis
- Bronchiectasis
- History of infection or active infection due to Mycobacterium tuberculosis
- Pneumoconiosis
- Pulmonary restriction due to any other pulmonary disease, apart from the one concerned with the study population
- Congestive heart failure class 2 or more of the New York Heart Association (NYHA)
- Reduced life expectancy due to other disease (defined as having an expected mortality of ≥25% five years from enrollment)
- Current use of ß-blockers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of Xolair (Omalizumab)to Improve Outcomes in Patients With COPD and Elevated IgE Levels, and Positive RAST or Skin Prick Tests
The objective is to conduct an exploratory study on the effect of Omalizumab on COPD patients with elevated IgE. Exploratory outcomes include to determine whether Omalizumab use: reduces exacerbations in COPD patients; or improves rescue medication use, decreases ICS use, modified Medical Research Council (MMRC) dyspnea score, St. George's Respiratory Questionnaire (SGRQ), 6-minute walk distance (6MWD), forced expiratory volume at one second (FEV1)(the latter 3 with BMI make up the BODE score), residual volume (RV), total lung capacity (TLC), exhaled nitric oxide (ENO), and determination C-reactive protein (CRP).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Omalizumab (Xolair), Placebo
- Keywords
- COPD, Exacerbation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omalizumab (Xolair)Drug
Also called Xolair
Bi-weekly
PlaceboDrug
Bi-Weekly
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | Not described Receives: Drug: Omalizumab (Xolair) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Exacerbations
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011
Why it stopped: Unable to find eligible subjects- study closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Russell P Bowler, MD, PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851370
- Sponsor's protocol ID
- NJ-241
- Status last verified
- Mar 2017
- First submitted
- 4 Feb 2009
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cazzola M, Dahl R. Inhaled combination therapy with long-acting beta 2-agonists and corticosteroids in stable COPD. Chest. 2004 Jul;126(1):220-37. doi: 10.1378/chest.126.1.220.
PubMed 15249466Bonay M, Bancal C, Crestani B. The risk/benefit of inhaled corticosteroids in chronic obstructive pulmonary disease. Expert Opin Drug Saf. 2005 Mar;4(2):251-71. doi: 10.1517/14740338.4.2.251.
PubMed 15794718Imfeld S, Bloch KE, Weder W, Russi EW. The BODE index after lung volume reduction surgery correlates with survival. Chest. 2006 Apr;129(4):873-8. doi: 10.1378/chest.129.4.873.
PubMed 16608932
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Xolair (Omalizumab)to Improve Outcomes in Patients With COPD and Elevated IgE Levels, and Positive RAST or Skin Prick Tests
- ClinicalTrials.gov ID
- NCT00851370
- Acronym / sponsor ID
- NJ-241
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, Exacerbation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to find eligible subjects- study closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jan 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (actual)
- First posted
- 25 Feb 2009 (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 objective is to conduct an exploratory study on the effect of Omalizumab on COPD patients with elevated IgE. Exploratory outcomes include to determine whether Omalizumab use: reduces exacerbations in COPD patients; or improves rescue medication use, decreases ICS use, modified Medical Research Council (MMRC) dyspnea score, St. George's Respiratory Questionnaire (SGRQ), 6-minute walk distance (6MWD), forced expiratory volume at one second (FEV1)(the latter 3 with BMI make up the BODE score), residual volume (RV), total lung capacity (TLC), exhaled nitric oxide (ENO), and determination C-reactive protein (CRP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: Omalizumab (Xolair) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Smoking-related COPD and aged between 40 and 70 yrs.
- Total IgE of 30-700 IU and a positive RAST or skin prick test result to one or more perennial environmental allergens (e.g. dust mite (Dermatophagoides farinae, Dermatophagoides pteronyssinus), cockroach, dog, or cat.)
- Any race or sex; women with childbearing potential are required to use an acceptable method for birth control and have a negative pregnancy test
- History of ≥2 exacerbations during 2 yrs previous to the enrollment date
- An exacerbation will be defined as an increase or new onset of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least 3 days requiring antibiotic or systemic steroid treatment. The severity of an exacerbation will be determined by the following:
Key exclusion criteria (19 listed)
- History of Omalizumab use
- Evidence of illicit drug use or abuse of alcohol.
- Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
- Known sensitivity to study drug(s) or class of study drug(s)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
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 |
|---|---|---|
| Omalizumab (Xolair)Also: XolairBi-weekly | Drug | Omalizumab |
| PlaceboBi-Weekly | Drug | Placebo |
Primary outcome
COPD Exacerbations
Time frame: 48 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Background: PubMed 15249466Cazzola M, Dahl R. Inhaled combination therapy with long-acting beta 2-agonists and corticosteroids in stable COPD. Chest. 2004 Jul;126(1):220-37. doi: 10.1378/chest.126.1.220.
- Background: PubMed 15794718Bonay M, Bancal C, Crestani B. The risk/benefit of inhaled corticosteroids in chronic obstructive pulmonary disease. Expert Opin Drug Saf. 2005 Mar;4(2):251-71. doi: 10.1517/14740338.4.2.251.
- Background: PubMed 16608932Imfeld S, Bloch KE, Weder W, Russi EW. The BODE index after lung volume reduction surgery correlates with survival. Chest. 2006 Apr;129(4):873-8. doi: 10.1378/chest.129.4.873.
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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.
Russell P Bowler, MD, PhD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omalizumab (Xolair) in people with Pulmonary Disease, Chronic Obstructive, run by National Jewish Health at 1 site 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 15 inclusion and 19 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: withdrawn, as of the sponsor's last update on 29 Mar 2017. 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 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 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 was withdrawn before enrolling participants, so there are no results.
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?
COPD Exacerbations (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00851370, which also lists 3 linked publications.
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 29 Mar 2017.