NCT01722773

Completed

Trial of Non-invasive Ventilation for Stable COPD

University of Iowa Source

Other study identifiers

Sponsor study identifier

NPPV

Study Type

interventional

Estimated enrollment

40

Locations

1 country

Sites

1

Timeline

Study Start

April 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2004

Actual (reported)

Study Completion

April 2004

Actual (reported)

Brief Summary

The use of domiciliary non-invasive positive pressure ventilation (NPPV) in stable chronic obstructive pulmonary disease (COPD) with chronic hypercapnic respiratory failure has yielded variable effects on survival, quality of life and dyspnea. The investigators hypothesized that use of NPPV in stable COPD might result in improvement in quality of life and dyspnea.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 40 participants
Study completion date: April 2004
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2001
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
April 2004
Actual (reported)
Study Completion
April 2004
Actual (reported)
First Submitted
November 1, 2012
Actual (reported)
First Posted
November 7, 2012
Actual (reported)

Last Updated: November 7, 2012
Status Verified: November 2012
Last Update Submitted: November 5, 2012

Conditions

COPD

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

CRDQ
Chronic Respiratory Disease Questionnaire
6 months

Secondary Outcomes (4)

6-minutes walk test
6 months
TDI
6 months
PO2
6 months
NIF
6 months

Other Outcomes (1)

Side effect questionnaire
6 months

Study Arms (2)

Bipap

ACTIVE COMPARATOR

Bipap

Device: Bipap (Respironics, Inc)

Standard of care

NO INTERVENTION

No intervention

Interventions

Bipap (Respironics, Inc)Device

Bipap every night pressure at 15/5 with heated humidifier

Also known as: Non-invasive Positive pressure ventilation

Bipap

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age35 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

stable chronic obstructive pulmonary disease (COPD) defined as forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC) ratio of \<0.70, with at least 10 pack-years smoking history

You may not qualify if:

Sponsors & Collaborators

University of Iowa
Otherlead

Study Sites (1)

Univeristy of IOwa

Iowa City, Iowa, 52241, United States

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway Management

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Staff Physician

Study Record Dates

First Submitted

November 1, 2012

First Posted

November 7, 2012

Study Start

April 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

April 2004

NCT00972868

A Novel Unidirectional Face Mask During NPPV in COPD Patients

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Mindfulness Mediation Intervention in Chronic Obstructive Pulmonary Disease (COPD)

Not ApplicableCompleted

NCT01372462

Effects of the Breathe Technologies Ventilation System in Subjects With Chronic Obstructive Pulmonary Disease

Not ApplicableCompleted

NCT00325754

Benefits of Lightweight Ambulatory Oxygen Systems for Individuals With Chronic Obstructive Pulmonary Disease

Not ApplicableTerminated

NCT07125053

COPD Resources, Education, and Activity Designed for You Study

Not ApplicableRecruiting

NCT04210050

Sleep Ventilation for Patients With Advanced Hypercapnic COPD

Not ApplicableWithdrawn

congestive heart failure, obstructive sleep apnea, chronic respiratory conditions other than COPD, age \< 35 years, any disease limiting life expectancy to less than two years, active malignancy other than non-melanotic skin cancer in the previous two years, and with any anatomic variation or disease process that precluded wearing a nasal mask

Contact the study team to confirm eligibility.

Therapeutics

Respiratory Therapy

Actual (reported)

Study Completion

April 2004

Actual (reported)

Last Updated

November 7, 2012

Record last verified: 2012-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01722773
Data provider: ClinicalTrials.gov
Source updated: 2012-11-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:09 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (1)

Study Arms (2)

Bipap

Standard of care

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

Source record

Locations