search
Back to results

Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis (IMPALA)

Primary Purpose

Autoimmune Pulmonary Alveolar Proteinosis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Molgramostim
Placebo
PARI eFlow nebulizer system
Sponsored by
Savara Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Pulmonary Alveolar Proteinosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • aPAP diagnosed by computed tomography, or by biopsy, or by Broncho Alveolar Lavage (BAL), and by increased GM-CSF autoantibodies in serum.
  • Stable or progressive aPAP during a minimum period of 2 months prior to the Baseline visit.
  • Arterial oxygen tension (PaO2) <75 mmHg/<10 kilo Pascal (kPa) at rest, OR desaturation of >4 percentage points on the 6MWT
  • An alveolar-arterial oxygen difference [(A-a)DO2] of minimum 25 mmHg/3.33 kPa
  • Female or male ≥18 years of age
  • Females who have been post-menopausal for >1 year or females of childbearing potential after a confirmed menstrual period using a highly efficient method of contraception (i.e. a method with <1% failure rate such as combined hormonal contraception, progesterone-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence), during and until 30 days after last dose of double-blind trial treatment. Females of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at dosing at Baseline (Visit 2) and must not be lactating
  • Males agreeing to use condoms during and until 30 days after last dose of double-blind medication, or males having a female partner who is using adequate contraception as described above
  • Willing and able to provide signed informed consent
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified in the protocol as judged by the investigator

Exclusion Criteria:

  • Diagnosis of hereditary or secondary PAP
  • WLL within 1 month of Baseline
  • Treatment with GM-CSF within 3 months of Baseline
  • Treatment with rituximab within 6 months of Baseline
  • Treatment with plasmapheresis within 3 months of Baseline
  • Treatment with any investigational medicinal product within 4 weeks of Screening
  • Concomitant use of sputum modifying drugs such as carbocysteine or ambroxol
  • History of allergic reactions to GM-CSF
  • Connective tissue disease, inflammatory bowel disease or other autoimmune disorder requiring treatment associated with significant immunosuppression, e.g. more than 10 mg/day systemic prednisolone
  • Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product
  • History of, or present, myeloproliferative disease or leukaemia
  • Known active infection (viral, bacterial, fungal or mycobacterial)
  • Apparent pre-existing concurrent pulmonary fibrosis
  • Any other serious medical condition which in the opinion of the investigator would make the participant unsuitable for the trial

Sites / Locations

  • UCLA
  • University of Florida
  • Cincinnati Children's Hospital Medical Center
  • Royal Prince Alfred Hospital
  • Aarhus University Hospital
  • CHU Rennes Hospital Pontchaillou
  • Westdeutsches Lungenzentrum am Universitätsklinikum Essen
  • Asklepios Fachkliniken München - Gauting
  • Thoraxklinik am Universitätsklinikum Heidelberg
  • Universitätsklinikum Schleswig-Holstein Zentralklinikum, Lübeck Medizinische Klinik III, Pneumologie
  • Attikon University Hospital
  • Rabin Medical Center
  • IRCCS Policlinico San Matteo
  • Niigata University Medical and Dental Hospital
  • National Hospital Organization Kinki-Chuo
  • Tohoku University Hospital
  • Aichi Medical University Hospital
  • Kanagawa Cardiovascular and Respiratory Center
  • Seoul National University Hospital
  • Asan Medical Center, Division of Pulmonary and Critical Care Medicine
  • Samsung Medical Center, Division of Pulmonary and Critical Care Medicine
  • St. Antonius Hospital
  • Hospital de dia de Pneumologia
  • Hospital Sao Joao
  • City Hospital St. Petersburg
  • II. Pulmonary Department National Institut for TB, Lung Diseases and Chest Surgery
  • Hospital University de Bellvitge (HUB)
  • Centre Hospitalier Universitaire Vaudois
  • Yedikule Pulmonary Diseases and Pulmonary Surgery Training and Research Hospital
  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Double-blind molgramostim once daily

Double-blind molgramostim intermittent

Double-blind placebo

Open-label molgramostim intermittent

Arm Description

Inhalation of molgramostim nebuliser solution 300 mcg once daily for 24 weeks

Inhalation of molgramostim nebuliser solution 300 mcg for 7 days and placebo nebuliser solution for 7 days for 24 weeks (12 cycles)

Inhalation of placebo nebuliser solution once daily for 24 weeks

Inhalation of molgramostim nebuliser solution 300 mcg for 7 days and placebo nebuliser solution for 7 days for 24 or 48 weeks from completion of the double-blind period

Outcomes

Primary Outcome Measures

Absolute Change From Baseline of Alveolar-arterial Oxygen Concentration (A-a(DO2)) After 24 Weeks of Treatment
Measurement of (A-a)DO2 was done by blood gas analysis. An arterial blood sample was collected in the supine position, after resting for at least 10 minutes (or longer if required to achieve stable oxygen saturation). The sample was analyzed for arterial oxygen tension (PaO2) and partial pressure of carbon dioxide (PaCO2). The calculation of (A-a)DO2 was done centrally by using a formula described in the protocol.

Secondary Outcome Measures

Change From Baseline in 6-minute Walking Distance (6MWD) After 24 Weeks of Treatment
The 6MWD was assessed by the use of 6-minute walking test (6MWT). The 6MWT was performed in accordance with the 2014 ATS/ERS guideline "field walking tests in chronic respiratory disease" (Holland et al. 2014) by technicians with documented training and experience. Where possible, the test was conducted with the participant breathing ambient atmospheric air. If the participant required oxygen supplementation at rest, a titration procedure was carried out as part of the 6MWT at screening in order to determine the oxygen flow rate required for the participant to complete the test. This flow rate was to be used during subsequent tests, if possible.
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score After 24 Weeks of Treatment
The SGRQ is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It consists of two parts, where Part 1 covers the participants' recollection of their symptoms over the preceding period (1 month recall used in this trial, Symptoms component) and Part 2 addresses the participants' current state in terms of disturbances to their daily physical activity (Activity component) and a wide range of disturbances of psycho-social function (Impact component). A total score as well as individual component scores were calculated. Scores (total and component) range from 0 to 100, with higher scores indicating more limitations.
Number of Whole Lung Lavage During 24 Weeks of Treatment
In all versions of the protocol (no participants were recruited under version 1.0), whole lung lavage (single lung or both lungs) was applied as rescue therapy. In protocol version 2.0, the criterion for performing whole lung lavage was an increase in (A-a)DO2 by more than 10 mmHg/1.33 kilopascal compared to baseline. In protocol version 3.0 onwards, the criterion for performing whole lung lavage was clinical worsening of aPAP based on symptoms, reduced exercise capacity and/or findings of hypoxemia or desaturation according to the investigator's judgement. In protocol versions 2.0 and 3.0, participants undergoing whole lung lavage during the double-blind period were to discontinue double-blind treatment, encouraged to continue to follow the same visit schedule and, if required, receive further whole lung lavage at the investigator's discretion. In protocol version 4.0 and 5.0, participants undergoing whole lung lavage were to continue double-blind treatment.
Number of Adverse Events (AEs) During 24 Weeks of Treatment
Treatment-emergent adverse events (AEs) were assessed on or after the first dose of trial drug to 28 days after last dose. Information about AEs was collected by the investigator by a non-leading question such as "have you experienced any new health problems or worsening of existing conditions" and by reporting events directly observed or spontaneously volunteered by participants (e.g., in the Subject Diary Card, where subjects were asked to record any AEs and answer questions regarding lung toxicity and known systemic effects). Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns. All AEs were assessed by the investigator for severity (mild, moderate, severe), outcome (recovered, not recovered, recovered with sequelae, fatal, unknown) and causality (unlikely, possible, probable, not applicable) according to current regulatory standards.
Number of Serious Adverse Events (SAEs) During 24 Weeks of Treatment
SAEs are 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 anomaly or birth defect May jeopardise the subject or may require intervention to prevent one or more of the other outcomes listed above (Important Medical Events)
Number of Adverse Drug Reactions (ADRs) During 24 Weeks of Treatment
All AEs judged by either the reporting investigator or the sponsor as having a reasonable causal relationship to a medicinal product qualify as ADRs. The expression reasonable causal relationship means that a causal relationship between a medicinal product and an AE is at least a reasonable possibility i.e. the relationship cannot be ruled out.
Number of Severe AEs During 24 Weeks of Treatment
All AEs were assessed by the investigator for severity (mild, moderate, severe) according to current regulatory standards: Mild: The AE is easily tolerated and does not interfere with daily activity. Moderate: The AE interferes with daily activity, but the subject is still able to function. Medical intervention may be considered. Severe: The AE is incapacitating and requires medical intervention.
Number of Participants With at Least 1 AE Leading to Treatment Discontinuation During 24 Weeks of Treatment
Participants could be discontinued from treatment and assessments at any time, if deemed necessary by the investigator. Potential reasons for discontinuation of treatment included e.g. unacceptable AE.

Full Information

First Posted
February 28, 2016
Last Updated
April 11, 2023
Sponsor
Savara Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02702180
Brief Title
Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis
Acronym
IMPALA
Official Title
A Randomised, Double-blind, Placebo-controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Savara Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor [rhGM-CSF]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will receive inhaled molgramostim intermittently (7 days on, 7 days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.
Detailed Description
The trial is a phase 2, randomized, double-blind, placebo-controlled multicentre clinical trial investigating efficacy and safety of inhaled molgramostim (rhGM-CSF) in patients with aPAP. The trial will include 2 periods; a double-blind treatment period consisting of up to 8 trial visits (Screening, Baseline, and at Weeks 4, 8,12, 16, 20 and 24 after randomisation) and a open-label follow-up period consisting of up to 5 trial visits (at Weeks 4, 12, 24, 36 and 48 post-treatment). In the double-blind treatment period, eligible subjects will be randomised to treatment for up to 24 weeks with either: 1) inhaled molgramostim (300 µg) once daily (MOL-OD), 2) inhaled molgramostim (300 µg) and matching placebo administered intermittently (7 days on and 7 days off) (MOL-INT) or 3) inhaled placebo once daily (PBO). During the follow-up period, all participants will receive inhaled molgramostim intermittently (7 days on, 7 days off). During the trial, whole lung lavage (WLL) may be applied as rescue therapy in case of significant clinical worsening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Pulmonary Alveolar Proteinosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Double-blind molgramostim once daily
Arm Type
Experimental
Arm Description
Inhalation of molgramostim nebuliser solution 300 mcg once daily for 24 weeks
Arm Title
Double-blind molgramostim intermittent
Arm Type
Experimental
Arm Description
Inhalation of molgramostim nebuliser solution 300 mcg for 7 days and placebo nebuliser solution for 7 days for 24 weeks (12 cycles)
Arm Title
Double-blind placebo
Arm Type
Placebo Comparator
Arm Description
Inhalation of placebo nebuliser solution once daily for 24 weeks
Arm Title
Open-label molgramostim intermittent
Arm Type
Experimental
Arm Description
Inhalation of molgramostim nebuliser solution 300 mcg for 7 days and placebo nebuliser solution for 7 days for 24 or 48 weeks from completion of the double-blind period
Intervention Type
Drug
Intervention Name(s)
Molgramostim
Other Intervention Name(s)
rhGM-CSF
Intervention Description
300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo nebulizer solution for inhalation
Intervention Type
Device
Intervention Name(s)
PARI eFlow nebulizer system
Intervention Description
PARI eFlow nebulizer system
Primary Outcome Measure Information:
Title
Absolute Change From Baseline of Alveolar-arterial Oxygen Concentration (A-a(DO2)) After 24 Weeks of Treatment
Description
Measurement of (A-a)DO2 was done by blood gas analysis. An arterial blood sample was collected in the supine position, after resting for at least 10 minutes (or longer if required to achieve stable oxygen saturation). The sample was analyzed for arterial oxygen tension (PaO2) and partial pressure of carbon dioxide (PaCO2). The calculation of (A-a)DO2 was done centrally by using a formula described in the protocol.
Time Frame
From baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in 6-minute Walking Distance (6MWD) After 24 Weeks of Treatment
Description
The 6MWD was assessed by the use of 6-minute walking test (6MWT). The 6MWT was performed in accordance with the 2014 ATS/ERS guideline "field walking tests in chronic respiratory disease" (Holland et al. 2014) by technicians with documented training and experience. Where possible, the test was conducted with the participant breathing ambient atmospheric air. If the participant required oxygen supplementation at rest, a titration procedure was carried out as part of the 6MWT at screening in order to determine the oxygen flow rate required for the participant to complete the test. This flow rate was to be used during subsequent tests, if possible.
Time Frame
From baseline to 24 weeks
Title
Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score After 24 Weeks of Treatment
Description
The SGRQ is designed to measure health impairment in patients with asthma and chronic obstructive pulmonary disease (COPD). It consists of two parts, where Part 1 covers the participants' recollection of their symptoms over the preceding period (1 month recall used in this trial, Symptoms component) and Part 2 addresses the participants' current state in terms of disturbances to their daily physical activity (Activity component) and a wide range of disturbances of psycho-social function (Impact component). A total score as well as individual component scores were calculated. Scores (total and component) range from 0 to 100, with higher scores indicating more limitations.
Time Frame
From baseline to 24 weeks
Title
Number of Whole Lung Lavage During 24 Weeks of Treatment
Description
In all versions of the protocol (no participants were recruited under version 1.0), whole lung lavage (single lung or both lungs) was applied as rescue therapy. In protocol version 2.0, the criterion for performing whole lung lavage was an increase in (A-a)DO2 by more than 10 mmHg/1.33 kilopascal compared to baseline. In protocol version 3.0 onwards, the criterion for performing whole lung lavage was clinical worsening of aPAP based on symptoms, reduced exercise capacity and/or findings of hypoxemia or desaturation according to the investigator's judgement. In protocol versions 2.0 and 3.0, participants undergoing whole lung lavage during the double-blind period were to discontinue double-blind treatment, encouraged to continue to follow the same visit schedule and, if required, receive further whole lung lavage at the investigator's discretion. In protocol version 4.0 and 5.0, participants undergoing whole lung lavage were to continue double-blind treatment.
Time Frame
From baseline to 24 weeks
Title
Number of Adverse Events (AEs) During 24 Weeks of Treatment
Description
Treatment-emergent adverse events (AEs) were assessed on or after the first dose of trial drug to 28 days after last dose. Information about AEs was collected by the investigator by a non-leading question such as "have you experienced any new health problems or worsening of existing conditions" and by reporting events directly observed or spontaneously volunteered by participants (e.g., in the Subject Diary Card, where subjects were asked to record any AEs and answer questions regarding lung toxicity and known systemic effects). Participants were also encouraged to contact the clinic in between visits if they experienced AEs or had any concerns. All AEs were assessed by the investigator for severity (mild, moderate, severe), outcome (recovered, not recovered, recovered with sequelae, fatal, unknown) and causality (unlikely, possible, probable, not applicable) according to current regulatory standards.
Time Frame
From baseline to 24 weeks
Title
Number of Serious Adverse Events (SAEs) During 24 Weeks of Treatment
Description
SAEs are 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 anomaly or birth defect May jeopardise the subject or may require intervention to prevent one or more of the other outcomes listed above (Important Medical Events)
Time Frame
From baseline to 24 weeks
Title
Number of Adverse Drug Reactions (ADRs) During 24 Weeks of Treatment
Description
All AEs judged by either the reporting investigator or the sponsor as having a reasonable causal relationship to a medicinal product qualify as ADRs. The expression reasonable causal relationship means that a causal relationship between a medicinal product and an AE is at least a reasonable possibility i.e. the relationship cannot be ruled out.
Time Frame
From baseline to 24 weeks
Title
Number of Severe AEs During 24 Weeks of Treatment
Description
All AEs were assessed by the investigator for severity (mild, moderate, severe) according to current regulatory standards: Mild: The AE is easily tolerated and does not interfere with daily activity. Moderate: The AE interferes with daily activity, but the subject is still able to function. Medical intervention may be considered. Severe: The AE is incapacitating and requires medical intervention.
Time Frame
From baseline to 24 weeks
Title
Number of Participants With at Least 1 AE Leading to Treatment Discontinuation During 24 Weeks of Treatment
Description
Participants could be discontinued from treatment and assessments at any time, if deemed necessary by the investigator. Potential reasons for discontinuation of treatment included e.g. unacceptable AE.
Time Frame
From baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: aPAP diagnosed by computed tomography, or by biopsy, or by Broncho Alveolar Lavage (BAL), and by increased GM-CSF autoantibodies in serum. Stable or progressive aPAP during a minimum period of 2 months prior to the Baseline visit. Arterial oxygen tension (PaO2) <75 mmHg/<10 kilo Pascal (kPa) at rest, OR desaturation of >4 percentage points on the 6MWT An alveolar-arterial oxygen difference [(A-a)DO2] of minimum 25 mmHg/3.33 kPa Female or male ≥18 years of age Females who have been post-menopausal for >1 year or females of childbearing potential after a confirmed menstrual period using a highly efficient method of contraception (i.e. a method with <1% failure rate such as combined hormonal contraception, progesterone-only hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence), during and until 30 days after last dose of double-blind trial treatment. Females of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at dosing at Baseline (Visit 2) and must not be lactating Males agreeing to use condoms during and until 30 days after last dose of double-blind medication, or males having a female partner who is using adequate contraception as described above Willing and able to provide signed informed consent Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures specified in the protocol as judged by the investigator Exclusion Criteria: Diagnosis of hereditary or secondary PAP WLL within 1 month of Baseline Treatment with GM-CSF within 3 months of Baseline Treatment with rituximab within 6 months of Baseline Treatment with plasmapheresis within 3 months of Baseline Treatment with any investigational medicinal product within 4 weeks of Screening Concomitant use of sputum modifying drugs such as carbocysteine or ambroxol History of allergic reactions to GM-CSF Connective tissue disease, inflammatory bowel disease or other autoimmune disorder requiring treatment associated with significant immunosuppression, e.g. more than 10 mg/day systemic prednisolone Previous experience of severe and unexplained side-effects during aerosol delivery of any kind of medicinal product History of, or present, myeloproliferative disease or leukaemia Known active infection (viral, bacterial, fungal or mycobacterial) Apparent pre-existing concurrent pulmonary fibrosis Any other serious medical condition which in the opinion of the investigator would make the participant unsuitable for the trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cliff Morgan, MD
Organizational Affiliation
Royal Brompton Hospital London
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
CHU Rennes Hospital Pontchaillou
City
Rennes
Country
France
Facility Name
Westdeutsches Lungenzentrum am Universitätsklinikum Essen
City
Essen
Country
Germany
Facility Name
Asklepios Fachkliniken München - Gauting
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Thoraxklinik am Universitätsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein Zentralklinikum, Lübeck Medizinische Klinik III, Pneumologie
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Attikon University Hospital
City
Athens
Country
Greece
Facility Name
Rabin Medical Center
City
Petaẖ Tiqwa
Country
Israel
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
Country
Italy
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata
Country
Japan
Facility Name
National Hospital Organization Kinki-Chuo
City
Osaka
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Toyohashi
Country
Japan
Facility Name
Kanagawa Cardiovascular and Respiratory Center
City
Yokohama
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
0 3080
Country
Korea, Republic of
Facility Name
Asan Medical Center, Division of Pulmonary and Critical Care Medicine
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center, Division of Pulmonary and Critical Care Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
St. Antonius Hospital
City
Nieuwegein
Country
Netherlands
Facility Name
Hospital de dia de Pneumologia
City
Lisboa
Country
Portugal
Facility Name
Hospital Sao Joao
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
City Hospital St. Petersburg
City
St. Petersburg
Country
Russian Federation
Facility Name
II. Pulmonary Department National Institut for TB, Lung Diseases and Chest Surgery
City
Vyšné Hágy
ZIP/Postal Code
05984
Country
Slovakia
Facility Name
Hospital University de Bellvitge (HUB)
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
Country
Switzerland
Facility Name
Yedikule Pulmonary Diseases and Pulmonary Surgery Training and Research Hospital
City
İstanbul
ZIP/Postal Code
34020
Country
Turkey
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32897035
Citation
Trapnell BC, Inoue Y, Bonella F, Morgan C, Jouneau S, Bendstrup E, Campo I, Papiris SA, Yamaguchi E, Cetinkaya E, Ilkovich MM, Kramer MR, Veltkamp M, Kreuter M, Baba T, Ganslandt C, Tarnow I, Waterer G, Jouhikainen T; IMPALA Trial Investigators. Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis. N Engl J Med. 2020 Oct 22;383(17):1635-1644. doi: 10.1056/NEJMoa1913590. Epub 2020 Sep 7.
Results Reference
background

Learn more about this trial

Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis

We'll reach out to this number within 24 hrs