A Phase 2 interventional study of Inhaled molgramostim and Antimycobacterial regimen in Mycobacterium Infections, Nontuberculous, sponsored by Savara Inc.. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Savara Inc. · Phase 2, Interventional, and Treatment
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The trial is an open-label, non-controlled, multicenter, pilot clinical trial of inhaled molgramostim (recombinant human granulocyte-macrophage colony stimulating factor; rhGM-CSF) in subjects with persistent pulmonary non-tuberculous mycobacterial (NTM) infection. Participants will be treated for 24-weeks with inhaled molgramostim and followed up for 12-weeks after end of treatment. The primary aim of the trial is to investigate the efficacy of inhaled molgramostim on NTM sputum culture conversion to negative.
The study will comprise a Screening Visit, a Baseline Visit, a 24-week treatment period and a 12-week follow-up period. 30 adult participants with a history of chronic NTM infection with at least 2 positive cultures in the prior 2 years, of which at least one is within the last 6 months prior to Screening, will be considered for enrollment. Participants should provide a positive NTM sputum culture at Screening to be eligible.
Two subgroups of participants will be recruited:
The treatment period will consist of 14 trial visits (Screening [within 10 weeks of Baseline], Baseline, and every 4 weeks to Week 48 [visits at Weeks 28, 36 and 44 included telephone contact, others included clinic visits]) and a Follow-up visit 12 weeks after the end of treatment.
At the Baseline visit, eligible participants will start treatment with molgramostim nebulizer solution, 300 μg, administered by inhalation using an eFlow Nebulizer System. At each visit, sputum samples will be collected for staining and microscopy, and microbiological culture. In addition, clinical assessments including body weight, patient reported outcomes, and diffusion capacity of the lung for carbon monoxide (DLCO) will be conducted at each clinic visit. Spirometry will be assessed at Baseline, and at Weeks 12, 24, 32, 40 and 48. A 6-minute walk test (6-MWT) will be conducted at Baseline, at Weeks 12, 24, 48 and at the 12-week Follow-up visit. Safety laboratory samples will be collected at Screening, Baseline and at Weeks 4, 12, 24, 32, 40, 48 and at the 12-week Follow-up visit. Anti-GM-CSF antibodies will be assessed at Baseline, at Week 4, 12, 24, 32, 48, and at the 12-week Follow-up visit.
54 studies on the registry are indexed under Mycobacterium Infections, Nontuberculous; 19 are open to participants now.
This study's enrollment of 32 is below the median of 40 across 35 interventional studies indexed under Mycobacterium Infections, Nontuberculous.
Browse Mycobacterium Infections, Nontuberculous studies →Savara Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject fulfills one of the following criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inhaled molgramostim administered in participants who remain sputum culture positive while currently on a multidrug NTM guideline-based antimycobacterial regimen, which has been ongoing for at least 6 months prior to the Baseline Visit
Drug: Inhaled molgramostim · Drug: Antimycobacterial regimen
Inhaled molgramostim administered in participants who remain sputum culture positive but have stopped a multidrug NTM guideline-based antimycobacterial regimen at least 28 days prior to Screening due to lack of response or intolerance, or who never started such treatment
Drug: Inhaled molgramostim
300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
Also known as: rh-GM-CSF
Multidrug NTM guideline-based antimycobacterial regimen
Number of Participants With Sputum Culture Conversion to Negative
Sputum culture conversion is defined as at least 3 consecutive sputum samples without growth of NTM during the treatment period.
Time frame: 48 weeks
Number of Participants With Sputum Smear Conversion to Negative
Sputum smear conversion is defined as at least three consecutive negative acid-fast bacilli (AFB) stained sputum smears on microscopy during the treatment period among participants who were smear positive at Baseline.
Time frame: 48 weeks
Number of Participants With Durable Sputum Culture Conversion
Durability is defined as sputum culture conversion at or before Week 24 and culture still negative for growth of NTM at 12-weeks follow-up.
Time frame: 60 weeks
Number of Participants With Durable Sputum Smear Conversion
Durability is defined as sputum smear conversion at or before Week 48 and AFB stained smear still negative for NTM at 12-weeks follow-up among participants who were smear positive at Baseline.
Time frame: 60 weeks
Change From Baseline in Symptom Scores (Assessed Using Lower Respiratory Tract Infections - Visual Analogue Scale)
For each of the clinical symptoms of Lower Respiratory Tract Infections (dyspnea, fatigue, cough, pain, and sputum), the participant assessed the severity using a 10 cm visual analogue scale (VAS) ranging from 0 = no symptoms to 10 = worst possible symptoms. A total LRTI score was calculated by summing up the score of each symptom (i.e., total LRTI score ranged from 0 to 50).
Time frame: Baseline to Week 48
Change From Baseline in Symptom Scores (Assessed Using Quality of Life Questionnaire - Bronchiectasis (QOL-B))
The QOL-B questionnaire including 37 items on 8 scales (emotional functioning, health perceptions, physical functioning, respiratory symptoms, role functioning, social functioning, treatment burden, vitality) was used to assess participant's quality of life (QoL). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardised on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and QoL. Scales contain between 3 and 9 items, thus changing 1 answer category will correspond to a change of 11.1 to 3.7 points.
Time frame: Baseline to Week 48
Change From Baseline in Global Rating of Health (GRH)
GRH was assessed as an interviewer questionnaire, which assesses global health as "excellent, good, fair or poor". For analysis, these were scored as 1 (poor) to 4 (excellent).
Time frame: Baseline to Week 48
Change From Baseline in Body Weight
Time frame: Baseline to Week 48
Change From Baseline in 6-Minute Walking Distance (6MWD)
The 6-minute walk test (6MWT) was performed in accordance with the European Respiratory Society/American Thoracic Society (ERS/ATS) guideline by technicians with documented training and experience. The 6MWT was performed twice at each visit.
Time frame: Baseline to Week 48
Change From Baseline in Dyspnea Scores During a 6MWT
Time frame: Baseline to Week 48
Number of Adverse Events (AEs) During the Trial Period
All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
Time frame: 60 weeks
Number of Serious AEs (SAEs) During the Trial Period
SAEs were defined as any untoward medicinal occurrence or effect that at any dose: * Results in death * Is life-threatening * Requires hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability or incapacity * Is a congenital abnormality or birth defect * May jeopardise the participant or may require medical intervention to prevent one or more of the outcomes listed above (Important Medical Events).
Time frame: 60 weeks
Number of Adverse Drug Reactions (ADRs) During the Trial Period
All AEs were assessed by the investigator for causality (unlikely, possible, probable, not applicable) according to current regulatory standards. AEs which had a 'possible' or 'probable' causality were classified as ADRs.
Time frame: 60 weeks
Number of Severe AEs During the Trial Period
All AEs were assessed by the investigator for severity (mild, moderate, severe) according to current regulatory standards.
Time frame: 60 weeks
Number of Participants Withdrawn From Treatment Due to an AE During the Trial Period
Time frame: 60 weeks
Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Time frame: Baseline to Week 48
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) (% Predicted)
Time frame: Baseline to Week 48
Change From Baseline in Forced Vital Capacity (FVC) (% Predicted)
Time frame: Baseline to Week 48
Number of Subjects With Development of Anti-GM-CSF Antibodies in Serum
Analyses for anti-GM-CSF antibodies were performed at a central laboratory.
Time frame: 60 weeks
This was a multicenter study conducted in a total of 5 sites in Australia and the UK. First participant was enrolled on 1 March 2018 and last participant completed the study on 13 January 2020.
| Milestone | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Started | 14 | 18 |
| Completed | 11 | 16 |
| Not completed | 3 | 2 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
Sputum culture conversion is defined as at least 3 consecutive sputum samples without growth of NTM during the treatment period.
| Participants | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Number of Participants With Sputum Culture Conversion to Negative | 2 | 3 |
Sputum smear conversion is defined as at least three consecutive negative acid-fast bacilli (AFB) stained sputum smears on microscopy during the treatment period among participants who were smear positive at Baseline.
| Participants | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Number of Participants With Sputum Smear Conversion to Negative | 5 | 6 |
Durability is defined as sputum culture conversion at or before Week 24 and culture still negative for growth of NTM at 12-weeks follow-up.
| Participants | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Number of Participants With Durable Sputum Culture Conversion | 1 | 1 |
Durability is defined as sputum smear conversion at or before Week 48 and AFB stained smear still negative for NTM at 12-weeks follow-up among participants who were smear positive at Baseline.
| Participants | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Number of Participants With Durable Sputum Smear Conversion | 5 | 6 |
For each of the clinical symptoms of Lower Respiratory Tract Infections (dyspnea, fatigue, cough, pain, and sputum), the participant assessed the severity using a 10 cm visual analogue scale (VAS) ranging from 0 = no symptoms to 10 = worst possible symptoms. A total LRTI score was calculated by summing up the score of each symptom (i.e., total LRTI score ranged from 0 to 50).
| score on a scale | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Total score | 2.48 ± 9.13 | 4.32 ± 13.32 |
| Dyspnoea | 1.74 ± 2.50 | 0.91 ± 3.64 |
| Tiredness | 1.29 ± 3.63 | 1.08 ± 3.96 |
| Cough | 5.28 ± 3.08 | 3.35 ± 2.08 |
| Color of phlegm | -1.88 ± 3.54 | 0.28 ± 2.24 |
| Pain | 1.22 ± 2.76 | 0.58 ± 2.82 |
The QOL-B questionnaire including 37 items on 8 scales (emotional functioning, health perceptions, physical functioning, respiratory symptoms, role functioning, social functioning, treatment burden, vitality) was used to assess participant's quality of life (QoL). Each of the 37 items is scored from 1 to 4, and each of the 8 scale scores is standardised on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning and QoL. Scales contain between 3 and 9 items, thus changing 1 answer category will correspond to a change of 11.1 to 3.7 points.
| score on a scale | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Emotional functioning | 0.00 ± 8.33 | 3.12 ± 12.12 |
| Health perceptions | -12.96 ± 13.25 | -6.77 ± 21.99 |
| Physical functioning | -17.78 ± 21.34 | -7.50 ± 28.38 |
| Respiratory symptoms | -6.84 ± 8.24 | -4.34 ± 16.36 |
| Role functioning | -13.33 ± 14.91 | -10.42 ± 22.96 |
| Social functioning | -16.36 ± 15.43 | -7.81 ± 20.16 |
| Treatment burden | -3.70 ± 12.83 | 4.44 ± 21.66 |
| Vitality | -9.88 ± 12.96 | -7.64 ± 26.83 |
GRH was assessed as an interviewer questionnaire, which assesses global health as "excellent, good, fair or poor". For analysis, these were scored as 1 (poor) to 4 (excellent).
| score on a scale | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Change From Baseline in Global Rating of Health (GRH) | -0.78 ± 0.67 | -0.38 ± 0.81 |
| kilogram | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Change From Baseline in Body Weight | -1.77 ± 2.51 | -1.44 ± 3.09 |
The 6-minute walk test (6MWT) was performed in accordance with the European Respiratory Society/American Thoracic Society (ERS/ATS) guideline by technicians with documented training and experience. The 6MWT was performed twice at each visit.
| meter | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Change From Baseline in 6-Minute Walking Distance (6MWD) | -17.1 ± 62.5 | 12.5 ± 56.2 |
| score on a scale | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Change From Baseline in Dyspnea Scores During a 6MWT | 0.79 ± 0.92 | 1.43 ± 3.01 |
All trial subjects were carefully monitored for the occurrence of AEs during the trial period from Baseline (Visit 2) to the 12-week Follow-up visit (Visit 15). AEs were collected by the investigator by a non-leading question and by reporting events directly observed or spontaneously volunteered by participants. Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns.
| events | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Number of Adverse Events (AEs) During the Trial Period | 199 | 223 |
SAEs were defined as any untoward medicinal occurrence or effect that at any dose: * Results in death * Is life-threatening * Requires hospitalisation or prolongation of existing hospitalisation * Results in persistent or significant disability or incapacity * Is a congenital abnormality or birth defect * May jeopardise the participant or may require medical intervention to prevent one or more of the outcomes listed above (Important Medical Events).
| events | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Number of Serious AEs (SAEs) During the Trial Period | 14 | 17 |
All AEs were assessed by the investigator for causality (unlikely, possible, probable, not applicable) according to current regulatory standards. AEs which had a 'possible' or 'probable' causality were classified as ADRs.
| events | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Number of Adverse Drug Reactions (ADRs) During the Trial Period | 67 | 81 |
All AEs were assessed by the investigator for severity (mild, moderate, severe) according to current regulatory standards.
| events | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Number of Severe AEs During the Trial Period | 5 | 6 |
| Participants | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Number of Participants Withdrawn From Treatment Due to an AE During the Trial Period | 3 | 2 |
| percent predicted | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Change From Baseline in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | -4.565 ± 8.198 | -3.079 ± 7.766 |
| percent predicted | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) (% Predicted) | -1.7986 ± 10.2133 | -3.4011 ± 6.9830 |
| percent predicted | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) | -2.4575 ± 6.6511 | -2.6135 ± 7.7040 |
Analyses for anti-GM-CSF antibodies were performed at a central laboratory.
| Participants | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Number of Subjects With Development of Anti-GM-CSF Antibodies in Serum | 5 | 10 |
Collected over Baseline to 12-week follow-up (60 weeks in total).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inhaled Molgramostim/Antimycobacterials | 2/14 (14.3%) | 8/14 (57.1%) | 14/14 (100%) |
| Inhaled Molgramostim | 1/18 (5.6%) | 6/18 (33.3%) | 18/18 (100%) |
| Event | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| Infective exacerbation of bronchiectasisInfections and infestations | 4/14 | 3/18 |
| BronchiectasisRespiratory, thoracic and mediastinal disorders | 3/14 | 0/18 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/14 | 2/18 |
| Right ventricular failureCardiac disorders | 1/14 | 0/18 |
| VertigoEar and labyrinth disorders | 1/14 | 0/18 |
| DiarrhoeaGastrointestinal disorders | 1/14 | 0/18 |
| Mycobacterium avium complex infectionInfections and infestations | 1/14 | 1/18 |
| PneumoniaInfections and infestations | 1/14 | 0/18 |
| SepsisInfections and infestations | 1/14 | 0/18 |
| HypotensionVascular disorders | 0/14 | 1/18 |
| Event | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 9/14 | 13/18 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 9/14 | 9/18 |
| C-reactive protein increasedInvestigations | 6/14 | 3/18 |
| NauseaGastrointestinal disorders | 5/14 | 7/18 |
| HaemoptysisRespiratory, thoracic and mediastinal disorders | 5/14 | 3/18 |
| Eosinophil count increasedInvestigations | 4/14 | 6/18 |
| FatigueGeneral disorders | 4/14 | 4/18 |
| BronchiectasisRespiratory, thoracic and mediastinal disorders | 4/14 | 1/18 |
| DiarrhoeaGastrointestinal disorders | 4/14 | 5/18 |
| Infective exacerbation of bronchiectasisInfections and infestations | 4/14 | 5/18 |
No "analysis sets" were defined. All participants were included in the analyses/data presentations, equivalent to a Full Analysis Set.
| Age, Categorical(Participants) | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 12 | 16 |
| >=65 years | 10 | 6 | 16 |
| Age, Continuous(years) | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim | Total |
|---|---|---|---|
| Mean | 67.4 ± 9.9 | 66.0 ± 9.0 | 66.6 ± 9.3 |
| Sex: Female, Male(Participants) | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim | Total |
|---|---|---|---|
| Female | 12 | 10 | 22 |
| Male | 2 | 8 | 10 |
| Race (NIH/OMB)(Participants) | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 14 | 16 | 30 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim | Total |
|---|---|---|---|
| United Kingdom | 2 | 0 | 2 |
| Australia | 12 | 18 | 30 |
| NTM type(Participants) | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim | Total |
|---|---|---|---|
| Mycobacterium avium complex | 11 | 13 | 24 |
| Mycobacterium abscessus | 3 | 6 | 9 |
| Age at NTM diagnosis(years) | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim | Total |
|---|---|---|---|
| Mean | 60.9 ± 9.7 | 60.1 ± 11.7 | 60.4 ± 10.7 |
| Smoking status(Participants) | Inhaled Molgramostim/Antimycobacterials | Inhaled Molgramostim | Total |
|---|---|---|---|
| Never | 11 | 9 | 20 |
| Previous | 3 | 8 | 11 |
| Current | 0 | 1 | 1 |
9 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Oct 2019, 19 months.
Results were first posted in Jul 2024, 4 years 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Molgramostim
Mycobacterium Infections, Nontuberculous →
Savara Inc.