COPD 환자의 드로나비놀로 호흡 곤란 감소 (BONG)
BONG: 중증 및 극중 만성 폐쇄성 폐질환 환자 그룹에서 드로나비놀이 사용하여 중증 호흡곤란 완화 - 무작위 배정, 이중 맹검, 위약 대조, 교차 연구
This clinical trial examines whether Dronabinol, which contains the synthetic psychoactive compound tetrahydrocannabinol (THC), can alleviate severe breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (COPD).
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
This study is a randomized, controlled, double-blind, crossover trial evaluating the effectiveness of the pharmaceutical drug Dronabinol in patients with severe and very severe COPD.
The researchers will compare the effects of Dronabinol with a placebo (an identical-looking substance that contains no active drug) to determine if Dronabinol reduces breathlessness in COPD patients.
After enrollment, study subjects will undergo four weeks of treatment with both Dronabinol and the placebo in a blinded and randomized sequence. There is a two-week washout period between treatments. During these treatment phases, subjects will complete questionnaires about their daily experiences of breathlessness and wear a watch that records various health parameters.
The study includes eight visits: the initial enrollment and follow-up checks every two weeks. At these visits, subjects undergo tests for lung function and walking distance, and complete health status questionnaires. Additionally, blood samples for THC levels and hair samples for cortisol analysis are collected.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
-
-
Region Syddanmark
-
Vejle, Region Syddanmark, 덴마크, 7100
- Vejle Hospital - A part of Lillebaelt Hospital
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Refractory dyspnea despite optimal treatment
- COPD (GOLD 3,4)
- Breathlessness corresponding to mMRC score ≥ 3
- Informed written consent
- Age ≥ 18 years
- Cognitive relevant, of legal age
- Understands and speaks Danish
- For fertile women defined by amenorrhea for less than 12 months: negative HCG before entry into the trial
- For fertile and sexually active subjects: use of safe contraception during medication intake and 4 weeks after: intrauterine device (IUD) or hormonal contraception (oral contraceptive pill, implant, transdermal patch, vaginal ring or depot injection).
Exclusion Criteria:
- Ongoing infection or exacerbation of COPD within the last month (30 days)
- Regular treatment with THC or CBD within 1 month (30 days)
- Life expectancy less than 3 months (90 days)
- Treatment with medicines that, according to the summary of product characteristics, are strong inhibitors or inducers of CYP3A4, CYP2C9 or CYP2C19
- History of or current evidence of significant medical or psychiatric disorder that is considered by the investigator to put the subject at greater risk of experiencing an adverse event
- Current or past substance abuse where the investigator finds it too risky for the subject to be included in the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Dronabinol 20 mg, then placebo
In this arm, the study subject will first receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. |
Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
다른 이름들:
Dronabinol-matched placebo capsule containing no active substance. |
|
위약 비교기: Placebo, then dronabinol 20 mg
In this arm, the study subject will first receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. |
Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
다른 이름들:
Dronabinol-matched placebo capsule containing no active substance. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
기간: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
|
Difference in Numeric Rating Scale score of breathlessness interference of daily activities between active treatment and placebo
기간: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
|
Correlation between breathlessness rated on a daily numeric rating scale in relation to amount of THC blood level of the active treatment period
기간: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
|
Correlation between breathlessness interference of daily activities rated on a numeric rating scale in relation to amount of THC blood level of the active treatment period
기간: Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Assesses different dimensions of COPD. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in COPD Assessment Test questionnaire score between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Assesses the severity of physical COPD symptoms. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in Chronic Respiratory Disease Questionnaire score between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
A HRQL tool which incorporates patient perceptions of both physical and emotional health. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in Hospital Anxiety and Depression Scale questionnaire score between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Assess anxiety and depression symptoms in medical patients. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in Medical Research Council Dyspnea Scale questionnaire score between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
A simple and valid method of categorizing patients with COPD in terms of their disability that could be used to complement FEV1 in the classification of COPD severity. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in Epworth Sleepiness Scale questionnaire score between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Assesses person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in the spirometry parameter forced expiratory volume in 1. second (FEV1) between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
The FEV1 indicates the lung tissue's ability to release air during the first second of exhalation. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in the spirometry parameter forced vital capacity (FVC) between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
The FVC indicates the lung tissue's ability to release air during the entire exhalation. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in the spirometry parameter FEV1/FVC (ratio), between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Can indicate an obstructive pattern in the exhalation which are used in the diagnosis of COPD. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in six-minute walk test(6MWT) between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
6 minutes walking test measures breathlessness and performance ability. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference Borg dyspnea score conducted in relation to 6MWT between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
A numeric scale from 0 (no breathlessness) to 10 (extremely strong breathlessness) but not limited to 10 if subjects feel breathlessness above 10 |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in cortisol level in the hair samples between active treatment and placebo period
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
Measurement of stress through cortisol levels in the hair. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Difference in clinical parameters between active treatment and placebo period using a yet unspecified continuous monitoring device.
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
For several days in each treatment period we continuously measure blood oxygen saturation, electrodermal activity, pulse rate, sleep recording, temperature, respiratory rate, and activity counter. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
|
Difference in stand-to-sit-test between active treatment and placebo
기간: Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
A measurement for physical capability until breathlessness. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Ole Hilberg, Prof., MD, Medical Department, Vejle Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2024-513593-22-00
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
It is the plan to share SAP when this is finalized. It is undecided whether CSR and analytic code will be shared on a platform or available on reasonable request.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .