NCT00117182已完成2 期
A Phase II Study to Investigate Mannitol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD
Syntara13 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 13
- 主要终点
- Forced expiratory volume in one second (FEV1)
研究概览
简要总结
The purpose of this study is to determine whether the Aridol (mannitol) challenge test can predict response to treatment with inhaled corticosteroids in COPD subjects. Subjects will undergo an Aridol test and then 3 months of treatment with inhaled corticosteroids. The effect on lung function and quality of life will then be measured and correlated with the Aridol test result.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD (history, spirometry, symptoms including chronic cough and/or shortness of breath that is worse on exertion and/or excess sputum production)
- •Aged 45 - 80 years
- •Have pre-bronchodilator FEV1 > 1.4 litres and at least 60% of predicted for height, age and gender and a post-bronchodilator FEV1 <80% of predicted for height, age and gender
- •Post-bronchodilator FEV1/FVC < 70 %
- •≥ 10 pack years smoking history
- •As determined by the investigator, are capable and willing to:
- •perform all of the techniques necessary to measure lung function;
- •administer the dry powder mannitol.
- •Are capable of, and have given informed consent to, participating in this study in accordance with local regulations.
- •The subject must be in stable clinical condition at the time of, and for a period of 14 days prior to, their recruitment into the study. Stable clinical condition is defined as lack of:
- •change in sputum production (volume, colour, consistency);
- •increased cough;
- •worsening dyspnoea;
- •increased malaise, fatigue or lethargy;
- •reduction in exercise tolerance;
- •antibiotic treatment (for respiratory infection).
排除标准
- •Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
- •Subjects receiving treatment with inhaled corticosteroids (including combination therapies, e.g. Seretide®, Symbicort®) or oral corticosteroids within the last 6 weeks.
- •Subjects who have had an exacerbation or a chest infection within the 2 weeks prior to the study.
- •Subjects receiving antibiotic treatment for respiratory infection.
- •Known diagnosis of asthma or allergic rhinitis.
- •Myocardial infarction in the six months prior to enrolment.
- •Cerebral vascular accident in the six months prior to enrolment.
- •Ocular surgery in the three months prior to enrolment.
- •Abdominal surgery in the three months prior to enrolment.
- •Active tuberculosis (TB).
- •Lung cancer or any other malignancies, which are considered by the investigator as a contraindication to participating in the study.
- •Lung disease other than COPD (e.g. bronchiectasis).
- •Uncontrolled insulin-dependant or non-insulin dependant diabetes, i.e. >10% HbA1c.
- •Female subjects of reproductive capability, not using a reliable form of contraception
- •Inability to obtain informed consent from the subject or subject's authorised representative.
- •Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of, study entry.
- •Known intolerance to mannitol.
- •Uncontrolled hypertension - systolic blood pressure (BP) > 200 mmHg and or diastolic BP > 100 mmHg.
- •Planned pulmonary rehabilitation.
- •Have had major abdominal, chest or brain surgery in the three months prior to enrolment.
- •Have known cerebral, aortic or abdominal aneurysm.
结局指标
主要结局
Forced expiratory volume in one second (FEV1)
次要结局
- Exacerbation frequency
- Days on antibiotics
- Lung function values
- Response dose ratio (RDR)
- Dose of provoking stimulus causing a 15%, 12% or 10% fall in FEV1 (PD15, PD12, PD10)
- Quality of life assessed by St. George's Respiratory Questionnaire (SGRQ)- total score
- COPD clinical control scores (CCQ)
- Days off work or days unable to carry out normal activities
- Reversibility of airflow obstruction
研究者
研究点 (13)
Loading locations...
相似试验
撤回
不适用
Diagnostic Utility of Amyl Nitrite in Patients With Suspected Achalasia Undergoing High Resolution Esophageal Manometry (HREM)DysphagiaAchalasiaNCT02428959Johns Hopkins University
终止
不适用
An In-vitro Standardization of B Cell Elispot AssaysTransplant SensitizationPanel Reactive AntibodySensitization to HLA AntigensNCT01334281Northwestern University19
已完成
3 期
Anidulafungin In Treatment Of Candidemia In Asian SubjectsCandidemiaNCT00537329Pfizer43
进行中（未招募）
1 期
A study to evaluate the safety and efficacy of bb2121 in combination with other therapeutic agents in people who have Myeloma that is not responsive after treatment or who had Myeloma which has returned after a period of treatment.Multiple myeloma (MM) with progression during or within 6 months of the last treatment.MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10067095Term: Multiple myeloma progressionSystem Organ Class: 100000004864EUCTR2020-003248-10-ESCelgene Corporation334
已完成
1 期
Study Testing the Biologic Activity and Safety of an Immunotherapeutic in Patients With Newly Diagnosed Stage IV Kidney CancerRenal Cell CarcinomaNCT00272649Argos Therapeutics22