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Increased Lung Volume as Controller Therapy for Asthma

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ClinicalTrials.gov Identifier: NCT02953431
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Anne Dixon, University of Vermont

Brief Summary:

This is an early phase clinical trial to test the efficacy of elevating lung volume with positive expiratory pressure (CPAP) as a controller therapy for asthma in patients with a BMI ≥ 30 kg/m2.

There will be two phases to this trial.

Phase I:

In the first phase we will determine the optimal duration of CPAP that is effective as a controller therapy in asthma. Up to 9 participants will complete this this phase.

Phase II:

The 2nd phase will be a randomized double-blinded controlled trial of Sham CPAP versus CPAP 10 (using the duration of CPAP determined in phase I) as a controller therapy for asthma, and also to determine the effect o airway reactivity in healthy people with a BMI 30 kg/m2 and above. Twenty people with asthma and twenty controls will complete this phase.


Condition or disease Intervention/treatment Phase
Asthma Device: CPAP Phase 1 Phase 2

Detailed Description:

The effect of 10 versus 0 cmH2O CPAP on airways responsiveness to inhaled methacholine will be studied using an adaptive "3+3" phase I/II study design.

Dose Titration Phase (phase I):

The efficacy of 8 hours of CPAP on airway responsiveness will be tested in three subjects.

Efficacy will be defined as a 25% improvement in the impedance response to methacholine in all three subjects. If this occurs in all subjects, shorter durations of CPAP will be studied (4 hours then one hour).

Conversely, if "dose escalation" is required, 3 nights, then 7 nights of CPAP will be studied.

Randomized-controlled study phase (phase II):

Participants will be randomized to CPAP 10 or Sham 0. The duration of CPAP will be determined in the dose titration phase. The effect on response to inhaled methacholine, lung function and asthma control will be determined in patients with asthma and a BMI ≥ 30 kg/m2, and also in healthy controls without asthma


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Increased Lung Volume as Controller Therapy for Asthma
Actual Study Start Date : May 7, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Placebo Comparator: Sham CPAP
Participants will be randomized to Sham CPAP
Device: CPAP
CPAP will be administered with a CPAP machine

Active Comparator: CPAP 10
Participants will be randomized to CPAP 10
Device: CPAP
CPAP will be administered with a CPAP machine




Primary Outcome Measures :
  1. Change in impedance of lung in response to methacholine measured by forced oscillation [ Time Frame: Through study completion, an average of one week ]
    Average change in impedance in response to methacholine in participants assigned to Sham CPAP versus CPAP 10


Secondary Outcome Measures :
  1. Change in spirometric lung function (FEV1 and FVC) [ Time Frame: Through study completion, an average of one week ]
    Average change in lung function in response to methacholine in participants assigned to Sham CPAP versus CPAP 10

  2. Change in asthma control [ Time Frame: Through study completion, an average of one week ]
    Average change in asthma control in response to methacholine in participants assigned to Sham CPAP versus CPAP 10



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for people with asthma:

  1. Physician diagnosis of asthma
  2. PC20 to methacholine < 16 mg/ml
  3. Asthma diagnosis age => 18 years
  4. IgE < 100 IU/ml
  5. Ages 18-60 years
  6. BMI >=30 kg/m2

Inclusion Criteria for controls:

  1. No physician diagnosis of asthma
  2. PC20 to methacholine > 16 mg/ml
  3. IgE < 100 IU/ml
  4. Ages 18-60 years
  5. BMI >=30 kg/m2

Exclusion Criteria:

  1. Fever of > 38oC in last week
  2. FEV1 < 60 % predicted
  3. Other significant disease that in the opinion of the investigator would interfere with study.
  4. Inability to perform required testing.
  5. Smoking within last 6 months.
  6. ≥ 20 pack year smoking history
  7. Inability to provide informed consent
  8. Pregnancy
  9. Known obstructive sleep apnea/ high likelihood of obstructive sleep apnea
  10. Asthma exacerbation in the prior 6 weeks
  11. Stoke or heart attack in the prior 3 months
  12. Known aortic aneurysm


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953431


Contacts
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Contact: Anne Dixon, BM BCh 802 656 3525 anne.dixon@uvm.edu
Contact: Kevin Hodgdon 802 847 8602 kevin.hodgdon@UVMHealth.org

Locations
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United States, Vermont
Vermont Lung Center Recruiting
Colchester, Vermont, United States, 05446
Contact: Erick Maclean       erick.maclean@uvmhealth.org   
Sponsors and Collaborators
University of Vermont
Investigators
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Principal Investigator: Anne Dixon, BM BCh University of Vermont

Publications of Results:
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Responsible Party: Anne Dixon, Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier: NCT02953431     History of Changes
Other Study ID Numbers: 16-061
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be published in the archival literature, and this will include a complete description of experimental and analytical methods used. All original data will be stored and available to interested investigators with appropriate regulatory approvals in place

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Anne Dixon, University of Vermont:
Asthma
Obesity

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases