Trial Outcomes & Findings for Montelukast to Treat Bronchiolitis Obliterans (NCT NCT00656058)

Last Updated: 2018-04-09

Results Overview

Responsive disease (RD) will be defined as ≥15% absolute improvement in the percentage predicted FEV-1. Progressive disease (PD) will be defined as \>15% decrease in FEV-1 documented on 2 pulmonary function test (PFT) evaluations greater than 2 weeks apart. Stable disease (SD) will be defined as \<15% change in the absolute FEV-1.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

180 days

Results posted on

2018-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Montelukast to Treat Bronchiolitis Obliterans Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Overall Study STARTED	25
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Montelukast to Treat Bronchiolitis Obliterans Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Montelukast to Treat Bronchiolitis Obliterans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Montelukast to Treat Bronchiolitis Obliterans n=25 Participants Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	45.29 years STANDARD_DEVIATION 15.65 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Population: No data is available for the one missing participant.

Outcome measures

Outcome measures
Measure	Montelukast to Treat Bronchiolitis Obliterans n=19 Participants Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature Increased 5-13% of predicted	5 Participants
Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature Stable	7 Participants
Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature Declined	6 Participants
Number of Participants With Stable or Improved Predicted Forced Expiratory Volume 1 (FEV-1) With Published Literature Missing	1 Participants

PRIMARY outcome

Timeframe: 180 days

FEV-1 slope of decline was generated using regression line of FEV-1 value vs. days post hematopoietic stem cell transplant. Responsive disease (RD) for the slope of FEV-1 change will be an increase in the slope of absolute FEV-1. Progressive disease (PD) for the slope of FEV-1 change will be a decrease in the slope of absolute FEV-1. Stable disease (SD) for the slope of FEV-1 change will be a 0 change in FEV-1 slope.

Outcome measures

Outcome measures
Measure	Montelukast to Treat Bronchiolitis Obliterans n=19 Participants Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months Improved	9 Participants
Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months Stable	9 Participants
Number of Participants With Improved, Stable or Declined Forced Expiratory Volume 1 (FEV-1) Slope at 6 Months Declined	1 Participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 71 months and 17 days

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

Outcome measures

Outcome measures
Measure	Montelukast to Treat Bronchiolitis Obliterans n=25 Participants Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Number of Participants With Adverse Events	20 Participants

SECONDARY outcome

Timeframe: Baseline

Pulmonary function test performed for eligibility and baseline.

Outcome measures

Outcome measures
Measure	Montelukast to Treat Bronchiolitis Obliterans n=19 Participants Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Forced Expiratory Volume 1 (FEV-1)/Vital Capacity (VC)	0.5 Ratio Interval 0.29 to 0.78

SECONDARY outcome

Timeframe: 2 years

Population: This is a multicenter study and the number analyzed reflect data for evaluable subjects enrolled at the National Institutes of Health only.

Percentage of participants alive at 2 years.

Outcome measures

Outcome measures
Measure	Montelukast to Treat Bronchiolitis Obliterans n=12 Participants Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Percentage Overall 2-Year Survival	84 percentage of participants

SECONDARY outcome

Timeframe: Day 1 of study

Fluid from the bronchoalveolar lavage in adult participants (pediatric optional) will be collected and sent to the lab to be evaluated for infectious diseases by flow cytometry

Outcome measures

Outcome measures
Measure	Montelukast to Treat Bronchiolitis Obliterans n=19 Participants Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Number of Non-Infected Participants at Baseline With Cysteinyl Leukotriene Receptor Expression on Cluster of Differentiation (CD4) and CD8 T Cells, Granulocytes, and Eosinophils in Bronchoalveolar Lavage (BAL) Fluid	19 Participants

Adverse Events

Montelukast to Treat Bronchiolitis Obliterans

Serious events: 15 serious events

Other events: 16 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Montelukast to Treat Bronchiolitis Obliterans n=25 participants at risk Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Gastrointestinal disorders Anorexia	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
General disorders Death not associated with CTCAE term::Death NOS	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
General disorders Death not associated with CTCAE term::Multi-organ failure	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Gastrointestinal disorders Dehydration	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Gastrointestinal disorders Diarrhea	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Gastrointestinal disorders Gastrointestinal - Other (gastroenteritis)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Gastrointestinal disorders Hemorrhage, GI::Abdomen NOS	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Respiratory, thoracic and mediastinal disorders Hypoxia	12.0% 3/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection - Other (CMV reactivation)	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection - Other (pneumonia/infection with unknown ANC)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection - Other (sinusitis)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)	16.0% 4/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS	4.0% 1/25 • Number of events 4 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection with unknown ANC::Colon	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection with unknown ANC::Lung (pneumonia)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection with unknown ANC::Urinary tract NOS	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Musculoskeletal and connective tissue disorders Joint-effusion	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Nervous system disorders Mood alteration::Depression	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Hepatobiliary disorders Pancreatitis	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Respiratory, thoracic and mediastinal disorders Parainfluenza Pneumonia	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Respiratory, thoracic and mediastinal disorders RSV Pneumonia	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Vascular disorders Thrombosis/embolism (vascular access-related)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Skin and subcutaneous tissue disorders Urticaria (hives, welts, wheals)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Gastrointestinal disorders Vomiting	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.

Other adverse events

Other adverse events
Measure	Montelukast to Treat Bronchiolitis Obliterans n=25 participants at risk Montelukast for the treatment of BO following allogeneic or autologous stem cell transplant. Singular (Montelukast Sodium): Singular (Montelukast Sodium):5-10 mg (weight based dosing) PO HS
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)	16.0% 4/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Metabolism and nutrition disorders AST, SGOT(serum glutamic oxaloacetic transaminase)	16.0% 4/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	16.0% 4/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Metabolism and nutrition disorders Alkaline phosphatase	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Respiratory, thoracic and mediastinal disorders Cough	8.0% 2/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Blood and lymphatic system disorders Edema: limb	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Metabolism and nutrition disorders GGT (gamma-Glutamyl transpeptidase)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Gastrointestinal disorders Gastrointestinal - Other (Pneumatosis coli)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Blood and lymphatic system disorders Hemoglobin	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Respiratory, thoracic and mediastinal disorders Hemorrhage, pulmonary/upper respiratory::Lung	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Respiratory, thoracic and mediastinal disorders Hypoxia	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection - Other (Helicobacter pylori infection)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection - Other (S. Maltophilia)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection - Other (URI)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection - Other (Viral infection (evaluated by home physicians))	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection - Other (fever and URI symptoms)	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection - Other (upper respiratory infection)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection with unknown ANC::Lung (pneumonia)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Infections and infestations Infection with unknown ANC::Sinus	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Blood and lymphatic system disorders Leukocytes (total WBC)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Metabolism and nutrition disorders Lipase	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Blood and lymphatic system disorders Lymphopenia	4.0% 1/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Gastrointestinal disorders Mucositis/stomatitis (clinical exam)::Oral cavity	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Gastrointestinal disorders Nausea	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Nervous system disorders Neuropathy: sensory	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Nervous system disorders Neutrophils/granulocytes (ANC/AGC)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Respiratory, thoracic and mediastinal disorders Pain::Chest/thorax NOS	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	16.0% 4/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	8.0% 2/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Psychiatric disorders Psychosis (hallucinations/delusions)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other (URI)	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Renal and urinary disorders Renal/Genitourinary - Other (interstitial renal fibrosis)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Metabolism and nutrition disorders Triglyceride, serum-high (hypertriglyceridemia)	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Renal and urinary disorders Urinary frequency/urgency	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
General disorders Weight loss	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.
Musculoskeletal and connective tissue disorders Pain: joint	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 71 months and 17 days. The serious adverse events while on study are not possibly, probably, or definitely related to montelukast or attributed to research interventions.

Additional Information

Dr. Ronald E. Gress

National Cancer Institute

Phone: 301-496-1791

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place