Increased Lung Volume as Controller Therapy for Asthma

Asthma Clinical Trial

Official title:

Increased Lung Volume as Controller Therapy for Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02953431
• Other study ID #: 16-061
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 7, 2018
• Est. completion date: June 2024

Study information

• Verified date: March 2023
• Source: University of Vermont
• Contact: Anne Dixon, BM BCh
• Phone: 802 656 3525
• Email: anne.dixon[@]uvm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria for people with asthma:

1. 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

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)

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• CPAP
CPAP will be administered with a CPAP machine

Locations

Country	Name	City	State
United States	Vermont Lung Center	Colchester	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
University of Vermont	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (3)

Al-Alwan A, Bates JH, Chapman DG, Kaminsky DA, DeSarno MJ, Irvin CG, Dixon AE. The nonallergic asthma of obesity. A matter of distal lung compliance. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1494-502. doi: 10.1164/rccm.201401-0178OC. — View Citation

Bates JH, Dixon AE. Potential role of the airway wall in the asthma of obesity. J Appl Physiol (1985). 2015 Jan 1;118(1):36-41. doi: 10.1152/japplphysiol.00684.2014. Epub 2014 Oct 23. — View Citation

Chapman DG, Irvin CG, Kaminsky DA, Forgione PM, Bates JH, Dixon AE. Influence of distinct asthma phenotypes on lung function following weight loss in the obese. Respirology. 2014 Nov;19(8):1170-7. doi: 10.1111/resp.12368. Epub 2014 Aug 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in impedance of lung in response to methacholine measured by forced oscillation	Average change in impedance in response to methacholine in participants assigned to Sham CPAP versus CPAP 10	Through study completion, an average of one week
Secondary	Change in spirometric lung function (FEV1 and FVC)	Average change in lung function in response to methacholine in participants assigned to Sham CPAP versus CPAP 10	Through study completion, an average of one week
Secondary	Change in asthma control	Average change in asthma control in response to methacholine in participants assigned to Sham CPAP versus CPAP 10	Through study completion, an average of one week