Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01384981
Other study ID # BGL NIV
Secondary ID
Status Terminated
Phase N/A
First received June 27, 2011
Last updated September 3, 2015
Start date January 2011
Est. completion date September 2013

Study information

Verified date September 2015
Source Klinikum Berchtesgadener Land der Schön-Kliniken
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The aim of the study is to find out if nocturnal non-invasive ventilation during pulmonary rehabilitation increases exercise capacity and quality of life more than pulmonary rehabilitation alone.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- confirmed diagnosis of COPD in stages GOLD III/ IV

- receiving optimized medical treatment and long term oxygen therapy if needed

- patients consent to participate in this trial

- no treatment with NIV in the last 4 weeks

- treatment with NIV in the last 4 weeks due to an acute exacerbation

Exclusion Criteria:

- treatment with NIV in the last 4 weeks (except due to an acute exacerbation)

- Intolerance to perform NIV

- Acute exacerbation at baseline or during PR

- Hypercapnia > pCO2 55mmHg

- Inability to perform a 6 minute walking test

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
pulmonary rehabilitation


Locations

Country Name City State
Germany Schön Klinik Berchtesgadener Land Schönau am Königssee

Sponsors (2)

Lead Sponsor Collaborator
Klinikum Berchtesgadener Land der Schön-Kliniken ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in 6 minute walking distance change in 6 minute walking distance from baseline to day 25 day 1 and 25 No
Secondary change in quality of life (chronic respiratory questionnaire, CRQ) change in CRQ-Score from baseline to day 25 day 1 and 25 No
Secondary change quality of life (Saint George´s Respiratory Questionnaire, SGRQ) change in SGRQ-Score from baseline to day 25 day 1 and 25 No
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy