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Respiratory Tract InfectionsPhase 2NCT01432080

Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant

A Phase 2 study testing Prednisone, Azithromycin and Montelukast in people with Respiratory Tract Infections and Bronchiolitis Obliterans, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

For many patients with blood cancers, stem cell transplantation from a family member or from an unrelated donor remains the only potentially curative option. Unfortunately, up to 40% of patients develop chronic lung disease after the transplant, which substantially increases the risk of death in the long-term. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prednisone, Azithromycin and Montelukast
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
Sep 2011to 30 Dec 2013
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Allogeneic transplant within the prior 1 year
  • Age greater than or equal to 18 years
  • Capable of informed consent
  • Neutrophil engraftment has occurred
  • This is the first clinically-recognized episode of viral respiratory tract infection after transplant

Who cannot join

  • Proof or high suspicion for bacterial, fungal or any non-viral microorganism causing pneumonia
  • CMV, VZV or HSV pneumonia
  • Prior diagnosis of a chronic transplant-related non-infectious pulmonary complication (ex: BO, COP)
  • Treating physician believes the risk of systemic steroids is too great
  • Currently receiving prednisone at or greater than 0.25 mg/kg/day or the equivalent dose of another steroid
  • Currently receiving pentostatin
Show all 14Show fewer
  • Mycophenolate initiated de novo or increased within the past 4 weeks
  • Use of inhaled corticosteroids within the past 2 weeks for at least 1 week
  • Haploidentical or T-cell depleted graft
  • Lack of pre-transplant pulmonary function tests
  • Evidence of a prior symptomatic viral respiratory tract infection following transplant, whether treated or not
  • Allergy or adverse reaction to any of the study drugs
  • Relapse or progression of the underlying malignancy
  • Palliative care

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Maisonneuve-Rosemont Hospital (Hôpital Maisonneuve-Rosemont)

    Montreal, Quebec, H1T 2M4

Other trials in Canada

About this study

Official title: Does Increasing Immunosuppression Prevent Transplant-associated Lung-disease Triggered by Viral Respiratory Tract Infection Following Allogeneic Stem Cell Transplant? A Pilot Study

For many patients with blood cancers, stem cell transplantation from a family member or from an unrelated donor remains the only potentially curative option. Unfortunately, up to 40% of patients develop chronic lung disease after the transplant, which substantially increases the risk of death in the long-term. Currently, patients with transplant-related lung disease are treated with some combination of steroids and other immunosuppressant drugs, but only about 1 out of 5 improve.

The importance of our study is that the investigators aim to prevent the development of transplant-related chronic lung disease in the first place. Because a strong risk factor for such chronic lung disease is a prior viral respiratory tract infection, the investigators think there is a window of opportunity to intervene. As soon as "cold and flu" symptoms start, the investigators will treat patients with a combination of drugs aimed at eliminating damaging immune responses triggered by the virus. In the absence of such treatment, the investigators believe these lung-damaging immune responses would persist even after the virus disappears. Our hope is that preventive treatment might avoid the development of chronic lung disease, and this would substantially increase long-term survival in our transplant patients.

This is a pilot study. Once feasibility is established, the investigators will seek to expand this study into a definitive clinical trial.

Being tested
Prednisone, Azithromycin, Montelukast, Symbicort
Keywords
Pulmonary disease, chronic obstructive, Viral respiratory tract infections, Respiratory syncytial viruses, Influenza virus A, Influenza virus B, Transplantation, Allogeneic
Medical subject headings
Respiratory Tract Infections, Bronchiolitis Obliterans, Cryptogenic Organizing Pneumonia, Lung Diseases, Interstitial, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrednisoneDrug

    Also called Deltasone, Steroids

    Prednisone 0.75 mg/kg actual body weight/day PO for 7 days followed by a 7 day taper.

  • AzithromycinDrug

    Azithromycin 250 mg PO daily for 2 weeks, then 3 times per week until 3 months

  • MontelukastDrug

    Also called Singulair

    Montelukast 10 mg PO qhs for 3 months

  • SymbicortDrug

    Also called Budesonide, Formoterol

    Symbicort 200/6 mcg, 2 inhalations every 12 hours for 3 months

Study groups in NCT01432080
Study groupRoleWhat they receive
Standard of CareNo interventionStandard of Care includes fluids, antipyretics, ribavirin for RSV infection, and oseltamivir for influenza infection, and intravenous immune globulin for patients with low IgG levels.
SAMSExperimentalSubjects randomized to the SAMS arm will receive a four-drug combination (Steroids, Azithromycin, Montelukast, and Symbicort).
Receives: Drug: Prednisone; Drug: Azithromycin; Drug: Montelukast; Drug: Symbicort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative incidence of new chronic lung disease

    The incidence rate of new non-infectious pulmonary complications within the 6 month follow-up period will be calculated. Non-infectious pulmonary complications include new airflow obstruction, new restrictive lung disease, and new mixed obstruction/restriction as measured by spirometry at study enrolment, 2 and 8 weeks following viral infection, and by full pulmonary function tests at 3 and 6 weeks following viral infection.

    Measured: 6 months following diagnosis of the viral respiratory tract infection

Secondary outcomes (13)

  1. Prevalence of non-infectious pulmonary complications

    Non-infectious pulmonary complications (NIPCs) include airflow obstruction, restrictive lung disease, and mixed obstruction/restriction as determined by pulmonary function tests. The prevalence of NIPCs will be determined among subjects surviving to 6 months post viral respiratory tract infection.

    Measured: 6 months following the diagnosis of viral respiratory tract infection

  2. Long-term functional impairment as defined by need for supplemental oxygen

    The percentage of subjects needing at least 1 month of supplemental oxygen on most days per week, not counting the period of symptomatic viral respiratory tract infection, will be determined in both arms.

    Measured: 6 months post viral respiratory tract infection

  3. Patient-perceived long-term functional impairment

    A FACT-BMT questionnaire will be administered at baseline and again to subjects surviving 6 months post respiratory tract infection to measure patient-perceived functional impairment.

    Measured: 6 months post viral respiratory tract infection

  4. Time to clearance of viral infection

    Subjects in whom a respiratory virus is detected will undergo repeat testing every 2 weeks until the virus is no longer detectable. This is an exploratory analysis. The natural history of many of these community-acquired viruses in the transplant population is not known.

    Measured: Every 2 weeks until virus is no longer detectable

  5. Incidence of progression to respiratory failure

    This endpoint includes admission to hospital because of documented desaturation, need for supplemental oxygen, and need for mechanical ventilation.

    Measured: 21 days after enrolment

  6. Incidence of bacterial or fungal superinfection

    The incidence of secondary bacterial and fungal pneumonias will be compared in the two arms, to verify that the added immunosuppression does not contribute to further infectious complications.

    Measured: Within 21 days after enrolment

  7. Incidence of various other infectious complications

    The incidence of various other infectious complications, specifically including but not limited to CMV reactivations and CMV disease, zoster, and septicemia will be monitored in both arms.

    Measured: Within 6 months after enrolment

  8. Overall survival from date of viral respiratory tract infection

    Measured: 3 months post enrolment

  9. Overall survival from date of viral respiratory tract infection

    Measured: 6 months post enrolment

  10. Overall survival from date of transplant to end of study follow-up

    Measured: 6 months post enrolment

  11. Overall survival at 1 year post-transplant

    This measure will be applied to the group overall and also analyzed according to subgroups of patients presenting viral respiratory tract infections within 30 days of transplant, 31-100 days of transplant, and 101-365 days of transplant.

    Measured: 1 year post-transplant

  12. Cumulative incidence of death attributable to transplant associated lung disease

    Measured: 6 months post enrolment

  13. Cumulative incidence of death from other causes

    Measured: 6 months post enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2012
  4. Study completion30 Dec 2013

Why it stopped: Not meeting recruitment targets

Resources

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
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01432080
Sponsor's protocol ID
HMR1102
Status last verified
Oct 2021
First submitted
8 Sep 2011
Last updated
20 Oct 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prednisone, Azithromycin and Montelukast in people with Respiratory Tract Infections and Bronchiolitis Obliterans, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

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 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: stopped early, as of the sponsor's last update on 20 Oct 2021. 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 Canada. 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 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 stopped early (reason given: Not meeting recruitment targets). Results are not available in the source record.

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?

Cumulative incidence of new chronic lung disease (time frame: 6 months following diagnosis of the viral respiratory tract infection). 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 NCT01432080.

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 Oct 2021.

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