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Table 2 Ongoinga clinical trials with MIP as an endpoint

From: Maximum inspiratory pressure as a clinically meaningful trial endpoint for neuromuscular diseases: a comprehensive review of the literature

NCT number

Study Title

Study Design

Primary or Secondary Endpoint

Estimated Study Completion Date

Estimated Enrollment

Neuromuscular diseases

 Amyotrophic lateral sclerosis

  NCT02478450

Study to Investigate the Safety of the Transplantation (by Injection) of Human Glial Restricted Progenitor Cells (hGRPs; Q-Cells®) Into Subjects With Amyotrophic Lateral Sclerosis (ALS)

Nonrandomized, open-label, parallel group study

Secondary

December 2017

12

Duchenne muscular dystrophy

 NCT02310906

Phase I/II Study of SRP-4053 in DMD Patients

Randomized, placebo-controlled, double-blind, parallel group study

Secondary

December 2016

48

 NCT01999075

Stacking Exercises Aid the Decline in FVC and Sick Time (STEADFAST)

Randomized, single-blind, parallel group study

Secondary

August 2016

110

 NCT02255552

Confirmatory Study of Eteplirsen in DMD Patients (PROMOVI)

Nonrandomized, open-label, parallel group study

Secondary

May 2016

160

Myasthenia gravis

 NCT01047761

Exercise for Stable Myasthenia Gravis

Nonrandomized, open-label, single group study

Secondary

December 2015

30

Parkinson’s disease

 NCT02202057

Respiratory Load Magnitude Estimation in PD

Prospective, case control study

Secondary

August 2015

80

Pompe disease

 NCT02357225

A Pilot Study of Pyridostigmine in Pompe Disease

Nonrandomized, open-label, single group study

Primary

June 2017

16

 NCT02354651

Response to Diaphragmatic Pacing in Subjects With Pompe Disease

Prospective, observational study

Secondary

February 2017

12

 NCT01924845

BMN 701 Phase 3 in rhGAA Exposed Subjects With Late Onset Pompe Disease (INSPIRE Study)

Nonrandomized, open-label, single group study

Primary

June 2020

50

Pulmonary hypertension

 NCT02288442

Whole Muscle Exercise Training (WHOLEi + 12) in Pulmonary Hypertension

Randomized, single-blind, parallel group study

Secondary

September 2016

20

Sarcopenia

 NCT02120586

Preventive Physiotherapy Intervention in Elderly People With Sarcopenia

Randomized, single-blind, parallel group study

Primary

July 2015

70

X-linked myotubular myopathy

 NCT02453152

Respiratory Muscle Function in Untreated X-Linked Myotubular Myopathy (XLMTM)

Prospective, observational study

Secondary

December 2016

12

Other disorders (non-NMDs)

 Back pain

  NCT02429752

Low Back Pain and Breathing Pattern Dysfunction (LBP & BPD)

Open-label, single group study

Secondary

June 2016

75

Breast disease

 NCT02491762

The Effect of Breast Reconstruction Surgery Using Tissue Expanders on Respiratory Functions

Nonrandomized, open-label, parallel group study

Primary

August 2017

45

 NCT02165696

Compression Bandaging and Manual Lymph Drainage in Women With Lymphedema (LYMPHATIC)

Randomized, single-blind, parallel group study

Secondary

December 2015

44

COPD

 NCT01655199

Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease (CODEx)

Double-blind, single group study

Secondary

July 2014

40

 NCT01903772

Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD) (IMTCO)

Randomized, double-blind, parallel group study

Secondary

December 2015

72

 NCT01956565

Feasibility of Inspiratory Muscle Training in People With COPD Who Decline Pulmonary Rehabilitation

Nonrandomized, open-label, single group study

Secondary

November 2015

20

 NCT02392715

Inspiratory Muscle Training Combined With General Exercise Training in COPD (IMTGET)

Randomized, double-blind, parallel group study

Secondary

October 2016

80

 NCT02007772

Effectiveness of TNI vs. BiPAP in Chronic Global Insufficiency in COPD Patients (TIBICO)

Randomized, open-label, crossover study

Secondary

August 2015

85

 NCT01582958

The Effect of OMT on Patients With COPD: Correlating Pulmonary Function Tests With Biochemical Alterations

Randomized, single-blind, parallel group study

Primary

August 2015

60

 NCT01037387

Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients

Randomized, open-label, parallel group study

Secondary

June 2016

50

COPD or asthma

 NCT02233114

Do Yogic Exercises (12 weeks) Increase Respiratory Function in Patients with Obstructive Lung Diseases?

Randomized, single-blind, parallel group study

Secondary

December 2017

40

Chronic respiratory insufficiency

 NCT01458314

Non Invasive Mechanical Ventilation in Chronic Respiratory Insufficiency Patients During Rehabilitation

Randomized, open-label, parallel group study

Secondary

June 2015

50

Chronic respiratory failure

 NCT00994552

Comparison of Pressure Support and Pressure Control Ventilation in Chronic Respiratory Failure

Randomized, single-blind crossover study

Secondary

April 2010

20

Congenital heart disease

 NCT02438293

The Impact of Rhinovirus Infections in Paediatric Cardiac Surgery’ (RISK)

Prospective, observational study

Secondary

June 2016

250

Intraventricular hemorrhage

 NCT02231411

Neonatal Resuscitation With Intact Cord (NRIC)

Randomized, single-blind, parallel group study

Secondary

August 2016

150

Lung cancer

 NCT02493114

Functional Status in Patients Undergoing Curative Treatment for Lung Cancer

Prospective, observational study

Secondary

November 2017

80

Mechanically ventilated patients

 NCT02003053

A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT) in the ICU and CCU

Randomized, single-blind, parallel group study

Primary

September 2015

40

Obstructive sleep apnea

 NCT02259660

Airway Muscle Training for Obstructive Sleep Apnea (OSA)

Randomized, double-blind, parallel group study

Secondary

September 2016

60

Stroke

 NCT02400138

Home-based Respiratory Training After Stroke

Randomized, double-blind, parallel group study

Primary

November 2016

20

  1. aClinical trials in progress as of October 31st, 2015
  2. BiPAP biphasic positive airway pressure, CCU critical care unit, COPD chronic obstructive pulmonary disease, DMD Duchenne muscular dystrophy, FVC forced vital capacity, ICU intensive care unit, MIP maximum inspiratory pressure, OMT osteopathic manipulative treatment, PD Parkinson’s disease, TNI therapy with nasal insufflation