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临床试验/NCT00690885
NCT00690885终止2 期

Evaluation of Natural Human Interferon Alpha Lozenges in the Treatment of Chronic Cough in Patients With Chronic Obstructive Pulmonary Disease (COPD) or Idiopathic Pulmonary Fibrosis (IPF)

Ainos, Inc. (f/k/a Amarillo Biosciences Inc.1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2008年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
frequency/severity of cough

研究概览

简要总结

The purpose of this study is to determine whether lozenges containing interferon-alpha can reduce the frequency and severity of coughing in patients with chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF).

详细描述

Both chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) frequently lead to a chronic cough that negatively impacts the quality of life (QOL) for patients and those around them. This is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges given 3 times per day for 4 weeks, can reduce the frequency and severity of chronic cough in patients with COPD or IPF. Cough frequency will be assessed via 24-hour digital audio recordings made prior to entry, and at weeks 2 and 4 of treatment. Cough severity will be assessed via a 100-mm visual analog scale questionnaire completed by the subject prior to entry and then weekly during treatment. Subjects will also complete questionnaires regarding cough frequency, duration and intensity, QOL, dyspnea, and antitussive medication usage weekly during treatment. All questionnaires will be repeated weekly during a 4-week post-treatment observation period to assess durability of response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For all patients
  • history of clinically significant chronic cough for > 3 months
  • For COPD patients
  • >40 years of age
  • 20-pack-year history of smoking
  • GOLD classification of Stage 1 or higher
  • For IPF patients
  • > 50 years of age
  • history of unexplained dyspnea on exertion of > 3 months
  • exhibits coughing and bilateral, basilar, inspiratory crackles on physical exam
  • presents as being in a stable phase of IPF
  • lung biopsy or HRCT indicative of IPF

排除标准

  • ACE inhibitor use
  • current cancer or history of lung cancer
  • non-ambulatory
  • hospitalized in the previous 12 months for heart failure

研究组 & 干预措施

1

Experimental

lozenges containing 150 IU of natural human interferon-alpha

干预措施: interferon-alpha lozenges (Drug)

2

Placebo Comparator

matching placebo lozenges

干预措施: placebo lozenges (Drug)

结局指标

主要结局

frequency/severity of cough

时间窗: weekly

次要结局

  • quality of life(weekly)
  • anti-tussive medication usage(weekly)
  • dyspnea(weekly)

研究者

发起方
Ainos, Inc. (f/k/a Amarillo Biosciences Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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