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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 : August 3, 2020
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Anne Dixon, University of Vermont

Tracking Information
First Submitted Date  ICMJE April 29, 2016
First Posted Date  ICMJE November 2, 2016
Last Update Posted Date August 3, 2020
Actual Study Start Date  ICMJE May 7, 2018
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
Change in impedance of lung 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 PEEP 0 versus PEEP 10
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2018)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
  • 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 PEEP 0 versus PEEP 10
  • 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 PEEP 0 versus PEEP 10
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Increased Lung Volume as Controller Therapy for Asthma
Official Title  ICMJE Increased Lung Volume as Controller Therapy for Asthma
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.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE Device: CPAP
CPAP will be administered with a CPAP machine
Study Arms  ICMJE
  • Placebo Comparator: Sham CPAP
    Participants will be randomized to Sham CPAP
    Intervention: Device: CPAP
  • Active Comparator: CPAP 10
    Participants will be randomized to CPAP 10
    Intervention: Device: CPAP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2016)
29
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 18-65 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 18-65 years
  5. BMI >=30 kg/m2

Exclusion Criteria:

  1. FEV1 < 60 % predicted
  2. Other significant disease that in the opinion of the investigator would interfere with study.
  3. Inability to perform required testing.
  4. Smoking within last 6 months.
  5. ≥ 20 pack year smoking history
  6. Inability to provide informed consent
  7. Pregnancy
  8. Known obstructive sleep apnea/ high likelihood of obstructive sleep apnea
  9. Asthma exacerbation in the prior 6 weeks
  10. Stoke or heart attack in the prior 3 months
  11. Known aortic aneurysm
  12. Renal failure
  13. A known severe heart, vascular, liver, renal, or hematological disease
  14. Active allergic rhinitis
  15. Recent eye surgery (within the last month)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Anne Dixon, BM BCh 802 656 3525 anne.dixon@uvm.edu
Contact: Kevin Hodgdon 802 847 8602 kevin.hodgdon@UVMHealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02953431
Other Study ID Numbers  ICMJE 16-061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
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
Responsible Party Anne Dixon, University of Vermont
Study Sponsor  ICMJE University of Vermont
Collaborators  ICMJE Icahn School of Medicine at Mount Sinai
Investigators  ICMJE
Principal Investigator: Anne Dixon, BM BCh University of Vermont
PRS Account University of Vermont
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP