Autoimmune DiseasesNCT00039988
Treatment of Multiple Sclerosis With Copaxone and Albuterol
A study testing Glatiramer acetate and Albuterol in people with Autoimmune Diseases and Multiple Sclerosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS). MS is thought to be an autoimmune disease of the central nervous system. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Autoimmune Diseases, Multiple Sclerosis
- What is being tested?
- Glatiramer acetate and Albuterol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Nov 2007
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients may be eligible for this study if they:
- Have been diagnosed with RR-MS, within 2 years of diagnosis.
- Are 18-55 years old.
- Have RR-MS with evidence of demyelination on MRI scanning of the brain.
- Have extended disability status scale (EDSS) scores between 0 and 3.5.
- Have not taken Copaxone or oral myelin.
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- Have not had immunomodulating therapy for the past 3 months.
- Have not taken immunosuppressants.
- Have not had steroid treatment 1 month before entry.
- Have no evidence of active infection or cancer.
Who cannot join
- Patients may not be eligible for this study if they:
- Have a normal brain MRI.
- Are not willing to practice contraception (applies to women who are able to have children).
- Are pregnant or breast-feeding.
- Are currently taking any of the following drugs: beta2-adrenergic agonist or antagonist, diuretics, tricyclic antidepressants, or monoamine oxidase inhibitors.
- Have heart, blood, liver, or kidney problems.
Show all 10Show fewer
- Have a disease that affects blood clotting or lung function.
- Have abnormalities that relate to the endocrine system.
- Have a history of alcohol or drug abuse within 6 months of enrollment.
- Have been diagnosed with primary progressive MS, in which the disease slowly worsens without periods of recovery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital/Harvard Medical School
Boston, Massachusetts, 02115
About this study
Official title: Treatment of Multiple Sclerosis With Copaxone (Glatiramer Acetate) and Albuterol
The purpose of this study is to determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS).
MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.
Read the detailed description
MS is a chronic inflammatory disease of the central nervous system characterized by focal T cell and macrophage infiltrates that lead to demyelination and loss of neurologic function. Four therapies are currently approved for the treatment of MS. Three of these are approved for the treatment of patients with the relapsing-remitting (RR) form of MS, in which patients have clinical exacerbations followed by partial or complete recovery of function. These treatments are only modestly effective and are associated with significant toxicity, often causing patients to delay therapy for significant lengths of time. Thus, there is a need to find therapies with low toxicities that can be administered early during the disease course with the potential for arresting the disease.
During the pre-treatment phase, patients undergo neurological exams, including the extended disability status scale (EDSS), Ambulation Index (AI), disease steps (DS) scale MS functional composite score, PASAT, 9 hole peg test, and the 25 foot walking time. A 12-lead electrocardiogram (EKG) and chest x-ray are performed. Serum chemistry is assessed as well as electrolyte and thyroid stimulating hormone (TSH) levels. A brain MRI (with and without gadolinium), urinalysis, and urine pregnancy test (for women of reproductive potential) are performed. Blood is collected for mechanistic studies. In the treatment phase, patients are assigned randomly to 1 of 2 study arms:
Arm 1: Copaxone plus placebo. Arm 2: Copaxone plus albuterol. At the treatment visits, blood is collected and neurological exams and a brain MRI are performed. A pregnancy test is administered to women of reproductive potential. Neurological exams are performed every 6 months. MRIs are performed at baseline, Year 1, and Year 2. At the end of the study, patients have a complete physical exam, a neurological exam, and a brain MRI.
- Conditions
- Autoimmune Diseases, Multiple Sclerosis
- Being tested
- Glatiramer acetate, Albuterol, Albuterol placebo
- Keywords
- Treatment Outcome, Multiple Sclerosis, Albuterol, Copolymer 1
- Medical subject headings
- Autoimmune Diseases, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glatiramer acetateDrug
20 mg administered subcutaneously daily
AlbuterolDrug
2 mg or 4 mg oral capsules taken daily
Albuterol placeboDrug
Oral placebo capsules will be taken daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive Copaxone and albuterol placebo Receives: Drug: Glatiramer acetate; Drug: Albuterol placebo |
| 2 | Experimental | Participants will receive Copaxone and albuterol Receives: Drug: Glatiramer acetate; Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC)
Measured: Throughout study
Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines
Measured: At Months 3, 6, and 12
Secondary outcomes (6)
Change in IL-5 secretion in the supernatants of lines stimulated with glatiramer acetate
Measured: Throughout study
Change in percentage of IL-12-producing monocytes by intracytoplasmic staining
Measured: Throughout study
Time to first exacerbation
Measured: Throughout study
Number and severity of exacerbations
Measured: Throughout study
MRI evidence as measured by T2 lesion volume, number of enhancing lesions on T1 weighted images, and measurements of atrophy (brain parenchymal fraction, atrophy index)
Measured: At study entry and Months 12 and 24
Expanded Disability Status Scale (EDSS), Ambulation Index (AI), and Disease Steps (DS) scores
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2002 (estimated)
- Study startNov 2001
- Primary completionMar 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Autoimmunity Centers of Excellence
- Responsible party
- Sponsor
- Investigators
- Samia Khoury, Principal investigator, Brigham and Women's Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039988
- Sponsor's protocol ID
- DAIT AMS01
- Other IDs
- ACE Study AMS01
- Status last verified
- Sep 2016
- First submitted
- 18 Jun 2002
- Last updated
- 22 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Data access including but not limited to participant level data, is available to the public in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Publications
Khoury SJ, Healy BC, Kivisakk P, Viglietta V, Egorova S, Guttmann CR, Wedgwood JF, Hafler DA, Weiner HL, Buckle G, Cook S, Reddy S. A randomized controlled double-masked trial of albuterol add-on therapy in patients with multiple sclerosis. Arch Neurol. 2010 Sep;67(9):1055-61. doi: 10.1001/archneurol.2010.222.
PubMed 20837847
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Multiple Sclerosis With Copaxone (Glatiramer Acetate) and Albuterol
- ClinicalTrials.gov ID
- NCT00039988
- Acronym / sponsor ID
- DAIT AMS01
- Conditions
- Autoimmune Diseases, Multiple Sclerosis
- Keywords
- Treatment Outcome, Multiple Sclerosis, Albuterol, Copolymer 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Autoimmunity Centers of Excellence
- Study start
- Nov 2001
- Primary completion
- Mar 2006 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 20 Jun 2002 (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 determine the effects of glatiramer acetate (Copaxone) alone compared to Copaxone plus albuterol in patients with Multiple Sclerosis (MS).
MS is thought to be an autoimmune disease of the central nervous system. Certain white blood cells of the immune system become abnormally active and mistakenly attack the myelin of nerve fibers. Myelin is a fatty sheath that surrounds nerve fibers and insulates the nerve like insulation around an electrical wire. Without proper myelin insulation, messages sent between the brain and other parts of the body may be confused or fail completely. Damage to myelin causes the symptoms of MS. The most common form of MS is known as relapsing-remitting (RR), where partial or total recovery occurs after attacks. Four therapies are currently approved for the treatment of MS. These therapies, however, are only moderately effective and can cause undesirable side effects. For this reason, there is a need to find new therapies that have minimal side effects and may stop the disease from getting worse.
Detailed description
MS is a chronic inflammatory disease of the central nervous system characterized by focal T cell and macrophage infiltrates that lead to demyelination and loss of neurologic function. Four therapies are currently approved for the treatment of MS. Three of these are approved for the treatment of patients with the relapsing-remitting (RR) form of MS, in which patients have clinical exacerbations followed by partial or complete recovery of function. These treatments are only modestly effective and are associated with significant toxicity, often causing patients to delay therapy for significant lengths of time. Thus, there is a need to find therapies with low toxicities that can be administered early during the disease course with the potential for arresting the disease.
During the pre-treatment phase, patients undergo neurological exams, including the extended disability status scale (EDSS), Ambulation Index (AI), disease steps (DS) scale MS functional composite score, PASAT, 9 hole peg test, and the 25 foot walking time. A 12-lead electrocardiogram (EKG) and chest x-ray are performed. Serum chemistry is assessed as well as electrolyte and thyroid stimulating hormone (TSH) levels. A brain MRI (with and without gadolinium), urinalysis, and urine pregnancy test (for women of reproductive potential) are performed. Blood is collected for mechanistic studies. In the treatment phase, patients are assigned randomly to 1 of 2 study arms:
Arm 1: Copaxone plus placebo. Arm 2: Copaxone plus albuterol. At the treatment visits, blood is collected and neurological exams and a brain MRI are performed. A pregnancy test is administered to women of reproductive potential. Neurological exams are performed every 6 months. MRIs are performed at baseline, Year 1, and Year 2. At the end of the study, patients have a complete physical exam, a neurological exam, and a brain MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Glatiramer acetate, Drug: Albuterol placeboParticipants will receive Copaxone and albuterol placebo |
| 2 | Experimental | Drug: Glatiramer acetate, Drug: AlbuterolParticipants will receive Copaxone and albuterol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Have been diagnosed with RR-MS, within 2 years of diagnosis.
- Are 18-55 years old.
- Have RR-MS with evidence of demyelination on MRI scanning of the brain.
- Have extended disability status scale (EDSS) scores between 0 and 3.5.
- Have not taken Copaxone or oral myelin.
Key exclusion criteria (10 listed)
- Have a normal brain MRI.
- Are not willing to practice contraception (applies to women who are able to have children).
- Are pregnant or breast-feeding.
- Are currently taking any of the following drugs: beta2-adrenergic agonist or antagonist, diuretics, tricyclic antidepressants, or monoamine oxidase inhibitors.
- Have heart, blood, liver, or kidney problems.
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 |
|---|---|---|
| Glatiramer acetate20 mg administered subcutaneously daily | Drug | 1, 2 |
| Albuterol2 mg or 4 mg oral capsules taken daily | Drug | 2 |
| Albuterol placeboOral placebo capsules will be taken daily | Drug | 1 |
Primary outcome
Change in each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC)
Time frame: Throughout study
Glatiramer acetate-specific cytokine secretion of IL-13 cytokine secretion and IFN-gamma secretion by glatiramer acetate-reactive T-cell lines
Time frame: At Months 3, 6, and 12
6 secondary outcomes
Change in IL-5 secretion in the supernatants of lines stimulated with glatiramer acetate
Time frame: Throughout study
Change in percentage of IL-12-producing monocytes by intracytoplasmic staining
Time frame: Throughout study
Time to first exacerbation
Time frame: Throughout study
Number and severity of exacerbations
Time frame: Throughout study
MRI evidence as measured by T2 lesion volume, number of enhancing lesions on T1 weighted images, and measurements of atrophy (brain parenchymal fraction, atrophy index)
Time frame: At study entry and Months 12 and 24
Expanded Disability Status Scale (EDSS), Ambulation Index (AI), and Disease Steps (DS) scores
Time frame: Throughout study
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 Sep 2016.
- Results publication: PubMed 20837847Khoury SJ, Healy BC, Kivisakk P, Viglietta V, Egorova S, Guttmann CR, Wedgwood JF, Hafler DA, Weiner HL, Buckle G, Cook S, Reddy S. A randomized controlled double-masked trial of albuterol add-on therapy in patients with multiple sclerosis. Arch Neurol. 2010 Sep;67(9):1055-61. doi: 10.1001/archneurol.2010.222.
- Individual participant dataSharing planned: Yes. Data access including but not limited to participant level data, is available to the public in the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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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.
Samia Khoury principal investigator
Brigham and Women's Hospital/Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glatiramer acetate and Albuterol in people with Autoimmune Diseases and Multiple Sclerosis, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 10 inclusion and 10 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 Sep 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 each participant's disease status, as measured by the Multiple Sclerosis Functional Composite score (MSFC) (time frame: Throughout study). 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 NCT00039988, 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 22 Sep 2016.