NCT00592631

Brief Summary

We hypothesize that the nocturnal use of continuous positive airway pressure in adults and children with asthma will decrease airway reactivity.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

February 10, 2016

Completed
Last Updated

February 10, 2016

Status Verified

January 1, 2016

Enrollment Period

7.3 years

First QC Date

January 2, 2008

Results QC Date

November 12, 2015

Last Update Submit

January 12, 2016

Conditions

Asthma

Keywords

asthmasleep apnea

Outcome Measures

Primary Outcomes (1)

  • Change in Provocative Concentration of Methacholine Causing a 20% Fall in Forced Expiratory Volume in 1 Second (FEV1)

    Methacholine is an inhaled medication used to assess asthma and reactive airways. It was given at increasing concentrations (beginning with 0.0625 mg/ml and ending with 16.0 mg/ml). Each dose was followed by a lung measurement until a change of FEV1 of 20% occurs or until a maximum dose was reached, whichever came first.

    7 to 10 nights after cpap is started.

Study Arms (2)

CPAP

EXPERIMENTAL

Subjects will use CPAP of 8-12 during days 2 through 6 of the study.

Device: CPAP-Continuous Positive Airway Pressure

SHAM

SHAM COMPARATOR

Subjects will use sham CPAP of 0-2 during days 2 through 6 of the study.

Device: SHAM

Interventions

CPAP-Continuous Positive Airway PressureDEVICE

Cpap will be worn at night by subjects 6 to 7 days duration.

CPAP
SHAMDEVICE

SHAM will be worn at night by subjects 6 to 7 days duration.

SHAM

Eligibility Criteria

Age8 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children 8-18 years of age scheduled to start CPAP for obstructive sleep apnea.
  • Subjects can have clinically stable asthma, with no plans by their physician to change asthma therapy over the next month
  • Adults 18-60 years of age, seen in adult Pulmonary Clinic for sleep related problems who may require treatment with nocturnal continuous positive pressure (CPAP), which will be determined by polysomnography(PSG) will be approached to participate in the study.

You may not qualify if:

  • Cyanotic congenital heart disease.
  • History of acute respiratory symptoms for 3 weeks prior to testing.
  • Inability to perform pulmonary function testing adequately.
  • Escalation in asthma medication at time of recruitment.
  • SaO2 \<93% while awake and breathing room air
  • Baseline FEV1 \<75% predicted
  • Gastro-Esophageal Reflux requiring Medical management.
  • Chronic Obstructive Pulmonary Disease.
  • Use of Supplemental Oxygen.
  • Ischemic Heart Disease or Hypertension requiring treatment with medications other than diuretics.
  • Use of systemic corticosteroid therapy during the past 6 months.
  • Acute Respiratory Illness in the previous 8 weeks.
  • Juniper Score \<1.5
  • Baseline FEV1 \> or equal to 70%
  • Non-smoking for 6 months
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Busk M, Busk N, Puntenney P, Hutchins J, Yu Z, Gunst SJ, Tepper RS. Use of continuous positive airway pressure reduces airway reactivity in adults with asthma. Eur Respir J. 2013 Feb;41(2):317-22. doi: 10.1183/09031936.00059712. Epub 2012 Jul 26.

    PMID: 22835615DERIVED

MeSH Terms

Conditions

AsthmaSleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Results Point of Contact

Title
Robert Tepper, MD, Ph.D.
Organization
Indiana University
rtepper@iu.edu
317-274-9647

Study Officials

  • Robert S. Tepper, MD, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Mike Busk, MD

    NIFS/ Indiana University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2008

First Posted

January 14, 2008

Study Start

February 1, 2005

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 10, 2016

Results First Posted

February 10, 2016

Record last verified: 2016-01

Locations

US(1)