AsthmaPhase 3NATAIRNCT01007149
Effect of Omalizumab in Patients With Severe Persistent Non-atopic Uncontrolled Asthma
A Phase 3 study testing omalizumab in people with Asthma, run by Novartis Pharmaceuticals at 10 sites in France.
Trial summary
This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- omalizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 10 sitesFrance
- Study dates
- Sep 2009to Feb 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe persistent asthma with the following characteristics:
- Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year.
- Treated with high-dose inhaled corticosteroid (i.e. > 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid).
- Non-atopic, i.e. negative blood multiallergic testing and negative Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens
Who cannot join
- Current smokers or smoking history stopped for less than 3 years or > 10 pack years.
- Asthma exacerbation during the 4 weeks prior to randomization.
- Active lung disease other than non-atopic asthma.
- Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years.
- Pregnant or nursing (lactating) women.
- Treatment with omalizumab.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Novartis Investigative Site
Arnaud de Villeneuve
Novartis Investigative Site
Béthune
Novartis Investigative Site
Bordeaux
Novartis Investigative Site
Clamart
Novartis Investigative Site
Lyon
Novartis Investigative Site
Nantes
Novartis Investigative Site
Paris
Novartis Investigative Site
Strasbourg
Novartis Investigative Site
Suresnes
Novartis Investigative Site
Toulouse
About this study
Official title: A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy
This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.
- Conditions
- Asthma
- Being tested
- omalizumab, Placebo
- Keywords
- Severe asthma,, non-atopic,, omalizumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabDrug
Omalizumab was supplied in 5mL vials with solution for subcutaneous injection.
PlaceboDrug
Placebo was supplied in vials with solution for subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Omalizumab | Experimental | Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. Receives: Drug: omalizumab |
| Placebo | Placebo comparator | Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
Measured: Baseline and 16 weeks
Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
Measured: Baseline and 16 weeks
Secondary outcomes (7)
Change in Fractional Exhaled Nitric Oxide (FeNO)
FeNO was measured at baseline, and after 4, 8, 12 and 16 weeks of treatment. Absolute change in FeNO was expressed at each time point versus baseline value.
Measured: Baseline and 4, 8, 12 and 16 weeks
Change From Baseline in Induced Sputum Eosinophil Count
The induced sputum eosinophil count was measured in a subset of patients in selected centers. Sputum samples were collected at screening and Week 16. Sputum eosinophil count was expressed as a percentage of total nonsquamous cells. Absolute change in sputum eosinophil count was expressed versus baseline value.
Measured: Baseline and 16 weeks
Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
The shortened version of the asthma control questionnaire (symptoms plus β2-agonist) consists of 6 subscores (nighttime waking, symptoms on waking, activity limitation, shortness of breath, wheeze and rescue short-acting β2-agonist use) between 0 and 6 (0 = no impairment; 6 = maximum impairment) and a total score between 0 and 6 (subscores mean value). Absolute change in total score and subscores count was expressed versus baseline value. A decrease in score indicates improvement.
Measured: Baseline and 16 weeks
Change From Baseline in Nasal Symptom Global Score and Individual Components
Nasal symptom score calculated from six scales assessing the nasal symptom severity (sneezing, runny nose, congestion, itchy nose, postnasal drip and nasal symptoms overall). These six scores were rated on a scale from 1 to 7, with 7 being the worst rating. Absolute changes in these six scores were expressed versus baseline values. A negative change indicates improvement. The range of the global score was from 1 to 7, since this is the mean value of all the subscores.
Measured: Baseline and 16 weeks
Physician and Patient Global Evaluation of Treatment Effectiveness
The GETE is an assessment of asthma symptoms controlled in response to asthma treatment. The evaluation was performed independently by both investigator and patient using the same 5 point scale. The scale points are: excellent, good, moderate, poor and worsening. A good or excellent response is suggested as a means of defining a patient who has responded to treatment.
Measured: 16 weeks
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks
Spirometry was conducted according to internationally accepted standards. At least three maneuvers were performed at each sampling timepoint. The FEV1 recorded was taken from the maneuver obtained from the single best test curve. The best test curve was defined as the spirogram that gave the largest FEV1.
Measured: Baseline and 16 weeks
Number of Patients With at Least One Asthma-related Event Over 16 Weeks
Asthma-related events were: unscheduled medical visits, emergency room visits and hospitalizations. Details of exacerbations requiring oral or IV corticosteroids were recorded at each visit.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007149
- Sponsor's protocol ID
- CIGE025AFR05
- Other IDs
- 2009-010937-38, 2009
- Acronym
- NATAIR
- Status last verified
- Jul 2012
- First submitted
- 30 Oct 2009
- Last updated
- 20 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Garcia G, Magnan A, Chiron R, Contin-Bordes C, Berger P, Taille C, Devouassoux G, de Blay F, Couderc LJ, Didier A, O'Callaghan DS, Girodet PO, Bourdeix I, Le Gros V, Humbert M. A proof-of-concept, randomized, controlled trial of omalizumab in patients with severe, difficult-to-control, nonatopic asthma. Chest. 2013 Aug;144(2):411-419. doi: 10.1378/chest.12-1961.
PubMed 23579324
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-week Treatment, Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel-group Study to Assess the Effect of Omalizumab on the Expression of FcεRI Receptors of Blood Basophils and Dendritic Cells in Patients With Severe Persistent Non-atopic Asthma, Uncontrolled Despite Optimal Therapy
- ClinicalTrials.gov ID
- NCT01007149
- Acronym / sponsor ID
- NATAIR / CIGE025AFR05
- Conditions
- Asthma
- Keywords
- Severe asthma,, non-atopic,, omalizumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 3 Nov 2009 (estimated)
- Results
- Posted 8 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the change in the expression of FcεRI receptors of blood basophils and dendritic cells after 16 weeks of treatment with omalizumab as compared with placebo, in adult patients with non-atopic severe persistent asthma, uncontrolled despite optimal therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omalizumab | Experimental | Drug: omalizumabParticipants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Uncontrolled according to Global Initiative for Asthma (GINA) 2007 guidelines and at least 2 exacerbations having required systemic corticosteroid and/or at least 1 hospitalization or emergency room visit in the past year.
- Treated with high-dose inhaled corticosteroid (i.e. > 1,000 µg beclometasone dipropionate equivalent per day) plus inhaled long-acting β2 agonist (with or without maintenance oral corticosteroid).
- Non-atopic, i.e. negative blood multiallergic testing and negative Aspergillus-specific IgE-radio allergosorbent blood test and negative skin prick tests to a battery of common aeroallergens
Key exclusion criteria (7 listed)
- Current smokers or smoking history stopped for less than 3 years or > 10 pack years.
- Asthma exacerbation during the 4 weeks prior to randomization.
- Active lung disease other than non-atopic asthma.
- Patients with an active cancer, a suspicion of cancer or any history of cancer with less than 5 disease free years.
- Pregnant or nursing (lactating) women.
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 |
|---|---|---|
| omalizumabOmalizumab was supplied in 5mL vials with solution for subcutaneous injection. | Drug | Omalizumab |
| PlaceboPlacebo was supplied in vials with solution for subcutaneous injection. | Drug | Placebo |
Primary outcome
Change From Baseline in the Expression of FcεRI Receptors of Blood Basophils
Time frame: Baseline and 16 weeks
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of blood basophils (mean fluorescence intensity(MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
Change From Baseline in the Expression of FcεRI Receptors of Dendritic Cells
Time frame: Baseline and 16 weeks
Venous blood samples were collected at screening and at Week 16. Flow cytometry analysis determined the FcεRI receptors expression of dendritic cells (mean fluorescence intensity (MFI)). Relative change in mean fluorescence intensity at the end of study was expressed as a percentage of baseline value.
7 secondary outcomes
Change in Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Baseline and 4, 8, 12 and 16 weeks
Change From Baseline in Induced Sputum Eosinophil Count
Time frame: Baseline and 16 weeks
Change From Baseline in Score of the Shortened Version of the Asthma Control Questionnaire (Symptoms Plus Short-acting β2-agonist)
Time frame: Baseline and 16 weeks
Change From Baseline in Nasal Symptom Global Score and Individual Components
Time frame: Baseline and 16 weeks
Physician and Patient Global Evaluation of Treatment Effectiveness
Time frame: 16 weeks
Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to 16 Weeks
Time frame: Baseline and 16 weeks
Number of Patients With at Least One Asthma-related Event Over 16 Weeks
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23579324Garcia G, Magnan A, Chiron R, Contin-Bordes C, Berger P, Taille C, Devouassoux G, de Blay F, Couderc LJ, Didier A, O'Callaghan DS, Girodet PO, Bourdeix I, Le Gros V, Humbert M. A proof-of-concept, randomized, controlled trial of omalizumab in patients with severe, difficult-to-control, nonatopic asthma. Chest. 2013 Aug;144(2):411-419. doi: 10.1378/chest.12-1961.
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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 Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing omalizumab in people with Asthma, run by Novartis Pharmaceuticals at 10 sites in France.
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 4 inclusion and 7 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 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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 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?
Yes. Results are posted in the registry (first posted 8 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline in the Expression of FcεRI Receptors of Blood Basophils (time frame: Baseline and 16 weeks). The study lists 2 primary outcomes in all. 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 NCT01007149, which also lists 1 linked publication.
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 20 Jul 2012.