Trial Outcomes & Findings for Sham CPAP vs. Straight CPAP for Chronic Cough (NCT NCT03172130)

NCT ID: NCT03172130

Last Updated: 2020-06-18

Results Overview

Subjects will complete the Leicester Cough Questionnaire at the baseline and 6-week visits. The Leicester Cough Questionnaire comprises 19 items, which assess symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) are calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) is also calculated by adding the domain scores together. Higher scores indicate better quality of life. The change in Leicester Cough Questionnaire score will be compared between the Straight CPAP and Sham CPAP groups

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: Baseline and 6 weeks
• Results posted on: 2020-06-18

Participant Flow

Participant milestones

Measure	Straight CPAP Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Straight CPAP	Sham CPAP Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Sham CPAP
Overall Study STARTED	12	10
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	Straight CPAP Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Straight CPAP	Sham CPAP Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Sham CPAP
Overall Study Failure to tolerate CPAP/Sham CPAP	3	1

Baseline Characteristics

Ethnicity and Race information not collected

Baseline characteristics by cohort

Measure	Straight CPAP n=9 Participants Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Straight CPAP	Sham CPAP n=9 Participants Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Sham CPAP	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=9 Participants	7 Participants n=9 Participants	14 Participants n=18 Participants
Age, Categorical >=65 years	2 Participants n=9 Participants	2 Participants n=9 Participants	4 Participants n=18 Participants
Age, Continuous	52.4 years STANDARD_DEVIATION 10.9 • n=9 Participants	62.7 years STANDARD_DEVIATION 6.3 • n=9 Participants	57.2 years STANDARD_DEVIATION 10.27 • n=18 Participants
Sex: Female, Male Female	7 Participants n=9 Participants	4 Participants n=9 Participants	11 Participants n=18 Participants
Sex: Female, Male Male	2 Participants n=9 Participants	5 Participants n=9 Participants	7 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	—	0 Participants Ethnicity and Race information not collected
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	—	0 Participants Ethnicity and Race information not collected
Ethnicity (NIH/OMB) Unknown or Not Reported	—	—	0 Participants Ethnicity and Race information not collected
Race (NIH/OMB) American Indian or Alaska Native	—	—	0 Participants Ethnicity and race information not collected.
Race (NIH/OMB) Asian	—	—	0 Participants Ethnicity and race information not collected.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	—	0 Participants Ethnicity and race information not collected.
Race (NIH/OMB) Black or African American	—	—	0 Participants Ethnicity and race information not collected.
Race (NIH/OMB) White	—	—	0 Participants Ethnicity and race information not collected.
Race (NIH/OMB) More than one race	—	—	0 Participants Ethnicity and race information not collected.
Race (NIH/OMB) Unknown or Not Reported	—	—	0 Participants Ethnicity and race information not collected.

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Subjects will complete the Leicester Cough Questionnaire at the baseline and 6-week visits. The Leicester Cough Questionnaire comprises 19 items, which assess symptoms, or the impact of symptoms, over the last 2 weeks on a seven-point Likert scale. Scores in three domains (physical, psychological and social) are calculated as a mean for each domain (range 1 to 7). A total score (range 3 to 21) is also calculated by adding the domain scores together. Higher scores indicate better quality of life. The change in Leicester Cough Questionnaire score will be compared between the Straight CPAP and Sham CPAP groups

Outcome measures

Measure	Straight CPAP n=9 Participants Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Straight CPAP	Sham CPAP n=9 Participants Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Sham CPAP
Change in Leicester Cough Questionnaire Score	6.61 score on a scale Standard Error 1.36	2.07 score on a scale Standard Error 0.98

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Cough monitoring for 24 h at baseline, 6 weeks, and 12 weeks. Due to inadequate duration of cough monitoring data in study patients at baseline (24 hour), comparisons of cough frequency at 6 weeks and 12 weeks between these two groups could not be done in this study.

Subjects will wear a Leicester cough monitor for 24 hours at the baseline and 6-week visits, which will record cough frequency during that period. The change in cough frequency from baseline to 6 weeks will be compared between the Straight CPAP and SHAM CPAP groups

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. The 8 isoprostane level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups

Outcome measures

Measure	Straight CPAP n=9 Participants Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Straight CPAP	Sham CPAP n=9 Participants Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Sham CPAP
8 Isoprostane Level in Exhaled Breath Condensate Baseline	4.92 pg/mL Standard Deviation 2.23	3.99 pg/mL Standard Deviation 1.89
8 Isoprostane Level in Exhaled Breath Condensate 6 weeks	7.35 pg/mL Standard Deviation 3.47	5.04 pg/mL Standard Deviation 2.13

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. IL-6 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups

Outcome measures

Measure	Straight CPAP n=9 Participants Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Straight CPAP	Sham CPAP n=9 Participants Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Sham CPAP
Interleukin-8 (IL-8) Level in Exhaled Breath Condensate Baseline	1.52 pg/mL Standard Deviation 1.41	1.02 pg/mL Standard Deviation 0.24
Interleukin-8 (IL-8) Level in Exhaled Breath Condensate 6 weeks	1.00 pg/mL Standard Deviation 0.21	1.04 pg/mL Standard Deviation 0.18

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. NOX level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups.

Outcome measures

Measure	Straight CPAP n=9 Participants Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Straight CPAP	Sham CPAP n=9 Participants Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Sham CPAP
Nitrite/Nitrate (NOX) Level in Exhaled Breath Condensate Baseline	3.34 μmol/L Standard Deviation 2.07	3.35 μmol/L Standard Deviation 2.81
Nitrite/Nitrate (NOX) Level in Exhaled Breath Condensate 6 weeks	2.91 μmol/L Standard Deviation 2.32	5.26 μmol/L Standard Deviation 0.18

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. H2O2 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups

Outcome measures

Measure	Straight CPAP n=9 Participants Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Straight CPAP	Sham CPAP n=9 Participants Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Sham CPAP
Hydrogen Peroxide (H2O2) Level in Exhaled Breath Condensate Baseline	2458.02 nmol/L Standard Deviation 324.88	1714.42 nmol/L Standard Deviation 337.1
Hydrogen Peroxide (H2O2) Level in Exhaled Breath Condensate 6 weeks	1654.07 nmol/L Standard Deviation 239.71	1468.04 nmol/L Standard Deviation 143.58

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Population: Due to instability of LTB4 condensate samples stored greater than 3 weeks, LTB4 measurements were not analyzed.

Samples of breath condensate will be collected from study subjects at the baseline and 6-week visits. The change in LTB4 level from baseline to 6-weeks will be compared between the Straight CPAP and Sham CPAP groups

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Subjects will complete the GERD-QoL questionnaire at the baseline and 6-week visits. The GERD-QoL comprises 15 items on a five-point Likert scale; lowest possible score (0) = no symptoms, greatest possible score (75) = worst symptoms. The change in GERD-QoL score will be compared between the Straight CPAP and Sham CPAP groups

Outcome measures

Measure	Straight CPAP n=9 Participants Patients randomized to straight CPAP will receive 10 cm of air pressure, or as determined by the results of polysomnography, for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Straight CPAP	Sham CPAP n=9 Participants Patients randomized to sham CPAP will receive 1-2 cm of air pressure for 6 weeks. Following the 6-week visit, patients will be placed on straight CPAP with equipment approved by insurance for an additional 6 weeks. Sham CPAP
Change in Gastroesophageal Reflux Disease Quality of Life (GERD-QoL) Questionnaire Score	9.4 score on a scale Standard Deviation 22.25	6.3 score on a scale Standard Deviation 6.7

Adverse Events

Straight CPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham CPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Krishna Sundar

University of Utah

Phone: 801-581-7806

Email: krishna.sundar@hsc.utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place