Respiratory clinical trial failures

Phase II PPROM trial by The University of Texas Medical Branch, Galveston. Stop reason: OPERATIONAL.

Low study recruitment

Phase III Asthma trial by Hoffmann-La Roche. Stop reason: OPERATIONAL.

Sponsor decision to discontinue lebrikizumab development for the treatment of asthma.

Phase II Myelofibrosis trial by Incyte Corporation. Stop reason: OPERATIONAL.

The decision to close the study was made due to the expiration of remaining drug supply.

Phase III Asthma trial by University of Arizona. Stop reason: EFFICACY/FUTILITY.

The AZ-SWED trial was stopped by the National Heart, Lung, and Blood Institute (NHLBI) due to futility

Phase II Cystic Fibrosis trial by University Hospital, Bordeaux. Stop reason: OTHER/UNKNOWN.

Target number of inclusion not reached

Phase III Asthma trial by AstraZeneca. Stop reason: OPERATIONAL.

The study was discontinued due to slow recruitment, resulting from evolving clinical practices that reduced the use of maintenance oral corticosteroids for severe asthma treatment. The termination decision was not related to safety concerns.

Phase III COPD Exacerbation trial by University Hospital, Montpellier. Stop reason: OPERATIONAL.

low enrollment at participating centers

Phase II MAC Lung Disease trial by AN2 Therapeutics, Inc. Stop reason: OTHER/UNKNOWN.

EBO-301 truncated Phase 3 study (n=97) misses primary endpoint; results unable to confirm clinical efficacy observed in Phase 2 study.

Phase IV Respiratory Failure trial by Beth Israel Deaconess Medical Center. Stop reason: OPERATIONAL.

Study terminated due to lack of enrollment.

Phase III Acute Respiratory Distress Syndrome (ARDS) trial by Consorcio Centro de Investigación Biomédica en Red (CIBER). Stop reason: OPERATIONAL.

Persistently low recruitment of subjects

Phase II Acute Respiratory Distress Syndrome trial by Implicit Bioscience. Stop reason: OTHER/UNKNOWN.

withdrawn, not enrolling

Phase II Patent Ductus Arteriosus trial by University of South Alabama. Stop reason: OPERATIONAL.

very slow enrollment. Only one patient enrolled. Termination by PI

Unknown Cystic Fibrosis trial by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Stop reason: OPERATIONAL.

No recruitement, no grant to support this study

Unknown COPD (Chronic Obstructive Pulmonary Disease) trial by Medical University of Bialystok. Stop reason: OPERATIONAL.

Recruitment was temporarily suspended pending additional funding and activation of additional study centers. The pilot phase has been completed and is currently being evaluated. The suspension was not related to safety concerns.

Phase I Cystic Fibrosis trial by National Jewish Health. Stop reason: OPERATIONAL.

funding ended

Phase I Cystic Fibrosis trial by Boehringer Ingelheim. Stop reason: OPERATIONAL.

Sponsor decision

Phase II Hematopoietic Stem Cell Transplant (HSCT) trial by Children's Hospital Medical Center, Cincinnati. Stop reason: OPERATIONAL.

Study closed due to slow enrollment.

Phase III Bronchiolitis Obliterans trial by Zambon SpA. Stop reason: OPERATIONAL.

Study was terminated for business reasons. The earlier study end is not related to any safety concerns or data issues identified at any site or within the overall study data collected to date.

Phase II Asthma trial by RAPT Therapeutics, Inc.. Stop reason: SAFETY.

Study on clinical hold by FDA

Phase III Pulmonary Hypertension Associated With Interstitial Lung Disease trial by GB002, Inc.. Stop reason: OPERATIONAL.

Sponsor decision

Phase II Idiopathic Pulmonary Fibrosis trial by GlaxoSmithKline. Stop reason: EFFICACY/FUTILITY.

The study met futility criteria at pre-planned interim analysis, showing no clinical efficacy of the investigational drug. Based on the lack of efficacy at the interim data review, the sponsor decided to terminate the study.

Phase IV COPD Exacerbation trial by Esbjerg Hospital - University Hospital of Southern Denmark. Stop reason: OTHER/UNKNOWN.

Not possible to include patients at the required speed

Phase II Copd trial by McGill University Health Centre/Research Institute of the McGill University Health Centre. Stop reason: EFFICACY/FUTILITY.

Clinical trial discontinued for reason pertaining to lack of efficacy.

Phase II Copd trial by University Hospital, Lille. Stop reason: OTHER/UNKNOWN.

Following Brexit and the unavailability of the experimental drug (PT003) in France, the study was terminated prematurely.

Phase IV Acute Bronchiolitis trial by NYU Langone Health. Stop reason: OTHER/UNKNOWN.

Study design proved infeasible on the general inpatient pediatrics unit at the investigation site due to uncontrolled variables and protocol non-adherence.

Phase II Idiopathic Pulmonary Fibrosis trial by Genentech, Inc.. Stop reason: OTHER/UNKNOWN.

Sponsor decided to discontinue the study after review of clinical data by the iDMC. This decision was based on unblinded evaluation of clinical efficacy which showed a trend towards futility \& was not related to any safety concerns of vixarelimab.

Phase III Chronic Obstructive Pulmonary Disease trial by Chiesi Farmaceutici S.p.A.. Stop reason: OPERATIONAL.

Strategic decision by Sponsor; not due to safety reasons

Phase IV Asthma trial by Phoenix Children's Hospital. Stop reason: OPERATIONAL.

study halted prematurely before enrollment of first patient

Phase II Asthma trial by Kanecia Obie Zimmerman. Stop reason: OTHER/UNKNOWN.

The TBS02 study was paused indefinitely. No subjects were enrolled or treated, and the study may resume if circumstances change.

Phase II Idiopathic Pulmonary Fibrosis trial by Boehringer Ingelheim. Stop reason: OPERATIONAL.

Sponsor decision

Phase II Asthma trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Company Decision

Phase II Idiopathic Pulmonary Fibrosis trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase IV Bronchiectasis Adult trial by University of Dundee. Stop reason: OPERATIONAL.

Poor recruitment

Phase I Myelofibrosis trial by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Stop reason: OPERATIONAL.

Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.

Phase II Asthma in Children trial by Nemours Children's Clinic. Stop reason: OPERATIONAL.

Difficult enrollment

Phase II Chronic Obstructive Pulmonary Disease trial by Jiangsu HengRui Medicine Co., Ltd.. Stop reason: OTHER/UNKNOWN.

Sponsor's R\&D strategy adjusted.

Phase III Moderate Asthma trial by Eurofarma Laboratorios S.A.. Stop reason: OTHER/UNKNOWN.

Strategic change in development priorities

Phase II Uncontrolled Asthma trial by Chiesi Farmaceutici S.p.A.. Stop reason: OPERATIONAL.

Strategic decision by Sponsor; not due to safety reasons

Phase I Cystic Fibrosis, Pulmonary trial by Arrowhead Pharmaceuticals. Stop reason: OPERATIONAL.

Business decision

Phase III Chronic Obstructive Pulmonary Disease trial by Chiesi Farmaceutici S.p.A.. Stop reason: OPERATIONAL.

Strategic decision by Sponsor; not due to safety reasons

Phase III Eosinophilic Asthma trial by Areteia Therapeutics. Stop reason: SAFETY.

Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.

Phase III Eosinophilic Asthma trial by Areteia Therapeutics. Stop reason: SAFETY.

Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.

Phase III Eosinophilic Asthma trial by Areteia Therapeutics. Stop reason: SAFETY.

Program stopped due to the benefit risk profile no longer supports further development in the intended patient population.

Phase II Cystic Fibrosis trial by University Hospital, Brest. Stop reason: OPERATIONAL.

The centers have no longer patients. In September 2018, set up of a competitive international study.

Phase III Acute Respiratory Failure trial by Fred Hutchinson Cancer Center. Stop reason: EFFICACY/FUTILITY.

due to increased mortality and futility analyses

Phase II Interstitial Lung Disease trial by Matthias Griese. Stop reason: OTHER/UNKNOWN.

Lack of ressources after inspection and appropriate correcting actions to be taken

Phase II Idiopathic Pulmonary Fibrosis trial by Amgen. Stop reason: OTHER/UNKNOWN.

The trial was terminated due to not meeting primary or key secondary endpoints.

Phase I Cystic Fibrosis trial by University of Massachusetts, Worcester. Stop reason: OPERATIONAL.

Poor enrollment, patients were lost to follow up

Phase I Bronchiolitis Obliterans trial by M.D. Anderson Cancer Center. Stop reason: OTHER/UNKNOWN.

\<75% participation

Phase I Asthma trial by Arrowhead Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor business decision

Phase II Primary Myelofibrosis trial by Mayo Clinic. Stop reason: OTHER/UNKNOWN.

Study drug became commercially available

Phase I Bronchiolitis Obliterans Syndrome trial by Incyte Corporation. Stop reason: OPERATIONAL.

Business Decision

Phase II Chronic Obstructive Pulmonary Disease (COPD) trial by Columbia University. Stop reason: OTHER/UNKNOWN.

Difficulty finding Annexin study drug supplier

Phase I COPD trial by Xemed LLC. Stop reason: OTHER/UNKNOWN.

Regulatory Compliance

Phase III Respiratory Distress Syndrome, Adult trial by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Stop reason: OPERATIONAL.

The study was prematurely terminated following the funder's decision to withdraw financial support.

Phase II Bronchiectasis trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Strategic business decision

Phase III Stem Cell Transplant Complications trial by Assistance Publique - Hôpitaux de Paris. Stop reason: OPERATIONAL.

insufficient enrollment.

Phase I Allergic Asthma trial by Jasper Therapeutics, Inc.. Stop reason: OPERATIONAL.

Sponsor Decision - terminated due to changes in company priorities and not related to safety concerns.

Unknown Acute Exacerbation of Chronic Obstructive Pulmonary Disease trial by Hasselt University. Stop reason: OTHER/UNKNOWN.

The anticipated intervention could not be delivered due to low admission time

Phase II Sarcoidosis, Pulmonary trial by Kinevant Sciences GmbH. Stop reason: OPERATIONAL.

Sponsor Decision

Phase II Lung Transplant Rejection trial by The Hospital for Sick Children. Stop reason: OPERATIONAL.

Recruitment challenges

Phase IV Asthma trial by Galaxia Empírica. Stop reason: OPERATIONAL.

The study is closed due to lack of recruitment.

Phase I Myelofibrosis trial by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Stop reason: OPERATIONAL.

This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Phase II Asthma trial by AstraZeneca. Stop reason: OTHER/UNKNOWN.

The decision was based on lung findings from a non-clinical 13-week Good Laboratory Practice (GLP) toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.

Phase I Bronchopulmonary Dysplasia trial by University Hospitals Cleveland Medical Center. Stop reason: OTHER/UNKNOWN.

FDA hold

Phase IV Chronic Obstructive Pulmonary Disease trial by Fundacio Privada Mon Clinic Barcelona. Stop reason: OPERATIONAL.

Delays in the opening and activation of participating sites, and a low recruitment rate, with only 48 participants enrolled over the course of one year

Phase I Myelofibrosis trial by Novartis Pharmaceuticals. Stop reason: OPERATIONAL.

Sponsor Decision

Phase II Pulmonary Fibrosis trial by The University of Queensland. Stop reason: SAFETY.

Data Safety Monitoring Board recommended cessation due to futility

Phase II Idiopathic Pulmonary Fibrosis trial by Pliant Therapeutics, Inc.. Stop reason: SAFETY.

DSMB recommendation

Phase III Non-cystic Fibrosis Bronchiectasis trial by AstraZeneca. Stop reason: OPERATIONAL.

Due to the decision to stop recruitment early, enrolment into the MAHALE trial was terminated in August 2022; 139 patients were screened and 100 randomised to IP.

Phase II Mycobacterium Avium Complex Pulmonary Disease trial by Radboud University Medical Center. Stop reason: OPERATIONAL.

The trial was terminated prematurely after the enrollment of 12 out of 15 planned subjects, due to a lack of personnel and no option to continue study measurements.

Phase II Idiopathic Pulmonary Fibrosis trial by Actelion. Stop reason: OTHER/UNKNOWN.

Due to Protocol AC-055B201 (MUSIC) not meeting it's primary end point

Phase I Asthma trial by Emory University. Stop reason: OPERATIONAL.

The study terminated due to funding ending.

Unknown Respiratory Function Tests trial by The Second Affiliated Hospital of Chongqing Medical University. Stop reason: OTHER/UNKNOWN.

no patient enrolled.

Phase I Idiopathic Pulmonary Fibrosis trial by Orinove, Inc.. Stop reason: OTHER/UNKNOWN.

Partnership activities ongoing

Phase II Myelofibrosis trial by M.D. Anderson Cancer Center. Stop reason: OPERATIONAL.

0 participant accrual

Phase II Chronic Obstructive Pulmonary Disease (COPD) trial by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Stop reason: OPERATIONAL.

Per sponsor request. Closure was not prompted by any safety or efficacy concerns.

Phase IV Cystic Fibrosis trial by University of Alabama at Birmingham. Stop reason: EFFICACY/FUTILITY.

summary results revealed ineffective intervention and the trial was terminated prematurely. No formal statistical analysis was performed

Phase II Idiopathic Pulmonary Fibrosis trial by Modern Biosciences Ltd. Stop reason: OPERATIONAL.

Due to slow initial recruitment and a lack of confidence in our ability to complete recruitment within the forecasted timeframe.

Phase II Systemic Sclerosis trial by Michael M. Pham. Stop reason: OPERATIONAL.

Low enrollment

Phase I Bronchopulmonary Dysplasia (BPD) trial by Cynthia McEvoy. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Unknown Respiratory Disease trial by Samsung Medical Center. Stop reason: OPERATIONAL.

Identically designed study had been published before enrollment of first participant. Therefore, this study was not started. The IRB was approved the withdrawn of the study.

Phase II Acute Respiratory Distress Syndrome trial by National Taiwan University Hospital. Stop reason: OPERATIONAL.

Difficult enrollment

Phase III Pulmonary Mycobacterium Avium Complex Infection trial by RedHill Biopharma Limited. Stop reason: OPERATIONAL.

extremely slow enrollment into study

Phase II Cystic Fibrosis trial by University of Minnesota. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Unknown Pulmonary Disease, Chronic Obstructive trial by Prof. Dr. Jörg Leuppi. Stop reason: OPERATIONAL.

Low recruitment rate, motivation and engagement of participating GPs unfortunately declined over time, as well as the financial resources.

Phase IV Chronic Obstructive Pulmonary Disease trial by Mikkel Brabrand. Stop reason: OTHER/UNKNOWN.

Lack of inclusion of patients

Early Phase I Chronic Obstructive Pulmonary Disease trial by Virginia Commonwealth University. Stop reason: OPERATIONAL.

Funding was inconsistent and the Post-Doc left before the project ended

Phase III Progressive Fibrosing Interstitial Lung Disease trial by West Virginia University. Stop reason: OPERATIONAL.

Unable to enroll any subjects. IRB closed study in agreement with PI.

Phase III Acute Lung Injury trial by LEO Pharma. Stop reason: SAFETY.

A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.

Phase III Pulmonary Complications in Surgical Patients trial by University of Birmingham. Stop reason: OTHER/UNKNOWN.

Lack of IMP availability - may resume.

Phase II Interstitial Lung Disease trial by Franz Rischard, DO. Stop reason: OTHER/UNKNOWN.

Did not identify eligible candidates

Phase II Sarcoidosis, Pulmonary trial by University of Maryland, Baltimore. Stop reason: OTHER/UNKNOWN.

Many of sarcoidosis patients in this area already taking metformin

Phase IV Pulmonary Disease, Chronic Obstructive trial by Boehringer Ingelheim. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II Asthma trial by Boehringer Ingelheim. Stop reason: OTHER/UNKNOWN.

No stop-reason text available in the compact dataset.

Phase II COPD trial by Thirty Respiratory Limited. Stop reason: SAFETY.

Study stopping criteria were met. A safety event has occurred which was classified as an SAE and was related to the study intervention.

Phase I Lung Disease trial by Intellia Therapeutics. Stop reason: OPERATIONAL.

Clinical trial ITL-3001-CL-101 for the investigational product NTLA-3001 was withdrawn due to prioritization of other Sponsor programs.

Phase I Pulmonary Hypertension trial by AdventHealth. Stop reason: SAFETY.

based on DSMB recommendation at interim analysis

Phase II Lung Transplant Rejection trial by TFF Pharmaceuticals, Inc.. Stop reason: OPERATIONAL.

Study was terminated due to funding constraints

Phase II Chronic Obstructive Pulmonary Disease trial by Genentech, Inc.. Stop reason: OPERATIONAL.

The study was terminated by Sponsor due to patient recruitment challenges.