The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by University of South Florida.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of South Florida
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00870896
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
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Purpose
Does tiotropium effect the cough reflex in patients with COPD and chronic bronchitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease Chronic Bronchitis |
Drug: Tiotropium |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Effects of Tiotropium on the Cough Reflex in Patients With COPD |
Resource links provided by NLM:
Further study details as provided by University of South Florida:
Primary Outcome Measures:
- Cough reflex [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Tiotropium
Each subject will then receive Spiriva 18 ug/day for a total of 4 weeks. Each subject will be instructed by the PI on the proper use of the Spiriva inhaler and demonstrate the ability to properly perform the inhalation technique prior to leaving the laboratory. The patient will receive their first dose in the laboratory under the direct supervision of one of the investigators. In addition, subjects will be requested to take their Spiriva inhalation treatment the same time each day.
Other Name: Spiriva
Cough Questionnaire
This questionnaire is designed to assess the impact of cough on various aspects of your life. Read each question carefully and answer by CIRCLING the response that best applies to you. Please answer ALL questions, as honestly as you can.
- In the last 2 weeks, have you had chest or stomach pains as a result of your cough? 1 2 3 4 5 6 7 All of the time Most of the time A good bit of time Some time A little of the time Hardly any time None of the time
- In the last 2 weeks, have you been bothered by sputum (phlegm) production when you cough? 1 2 3 4 5 6 7 All of the time Most of the time A good bit of time Some time A little of the time Hardly any time None of the time
- In the last 2 weeks, have you been tired because of your cough? 1 2 3 4 5 6 7 All of the time Most of the time A good bit of time Some time A little of the time Hardly any time None of the time
- In the last 2 weeks, have you felt in control of your cough? 1 2 3 4 5 6 7 None of the time Hardly any time A little of the time Some time A good bit of time Most of the time All of the time
- How often during the last 2 weeks have you felt embarrassed by your coughing? 1 2 3 4 5 6 7 All of the time Most of the time A good bit of time Some time A little of the time Hardly any time None of the time
- In the last 2 weeks, my cough has made me feel anxious 1 2 3 4 5 6 7 All of the time Most of the time A good bit of time Some time A little of the time Hardly any time None of the time
- In the last 2 weeks, my cough has interfered with my job, or other daily tasks 1 2 3 4 5 6 7 All of the time Most of the time A good bit of time Some time A little of the time Hardly any time None of the time
- In the last 2 weeks, I felt that my cough interfered with the overall enjoyment of my life 1 2 3 4 5 6 7 All of the time Most of the time A good bit of time Some time A little of the time Hardly any time None of the time
- In the last 2 weeks, exposure to paints or fumes has made me cough 1 2 3 4 5 6 7 All of the time Most of the time A good bit of time Some time A little of the time Hardly any time None of the time
- In the last 2 weeks, has your cough disturbed your sleep? 1 2 3 4 5 6 7 All of the time Most of the time A good bit of time Some time A little of the time Hardly any time None of the time
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
After signing the informed consent, screening testing will be done to document that a subject meets the requirements of the study. Specific inclusion criteria are:
- Subjects between the ages of 40 and 80 years of age (Dates of Birth 1925-1965)
- Current smoker (with smoking history of > 10 pack/year) or ex-smoker (stopped within 1 year and has at least a 10 pack/year smoking history).
- Subjects will be included if they meet criteria for mild and moderate COPD as defined by the American Thoracic Society and European Respiratory Society position paper. Mild COPD will be defined as a postbronchodilator (2 puffs of albuterol) FEV1/FVC ratio of <0.7 and a predicted FEV1 of > 80%. Moderate COPD will be defined as a postbronchodilator FEV1/FVC ratio of <0.7 and a predicted FEV1 50-80%. A response to bronchodilators is defined as an increase of 12% or 200cc in FEV1 from baseline after inhalation of 2 puffs of albuterol. Both subjects with and without a response to bronchodilators will be included in the study.
- All subjects will be clinically stable for 4 weeks prior to inclusion. Clinical stability is defined as having no recent COPD exacerbations within the last 4 weeks and having received no antibiotics or change in their inhaled steroid dose during that time period. If a subject is on oral steroids, they will be required to be on 10 mg or less each day or no more than 20mg every other day to be eligible. If the oral steroid dose has been titrated over the previous 4 weeks (either up or down) or if the dose is higher than what has been described previously, they will be ineligible for the study.
- All subjects will be off of tiotropium or ipratropium for 1 month prior to the start of the study.
- Chronic cough: Chronic cough will be characterized by the presence of a productive cough for 3 months in each of 2 successive years in persons in whom other causes of chronic cough have been excluded.
Exclusion Criteria:Exclusion Criteria: Subjects will not be eligible for the study if they are
- Age of < 40 or > 80 years.
- Refusal to volunteer for the study and not willing to sign the informed consent form.
- Respiratory disorder other than COPD including asthma, chronic bronchiectasis or pulmonary fibrosis
- Oxygen or ventilator dependent COPD.
- Received any antibiotics or had a change in their inhaled steroid dose during the last 4 weeks. If a subject is on oral steroids, they will be required to be on 10 mg or less each day or no more than 20mg every other day to be eligible. If the oral steroid dose has been titrated over the previous 4 weeks (either up or down) or if the dose is higher than what has been described previously, they will be ineligible for the study.
- History of Congestive heart failure, cardiomyopathy, valvular heart disease, angina, cardiac arrhythmia, or myocardial infarction within the last 6 months or poorly controlled hypertension.
- History of chronic hepatitis or hepatic cirrhosis.
- End-stage renal disease.
- History of neurologic or psychiatric disorder which would interfere with completion of the study.
- Physician diagnosis of Gastroesophageal reflux disease
- Physician diagnosis of allergic, non-allergic rhinitis, or sinusitis
- History of lung cancer
- History of radiation treatment to the chest or mediastinum
- Lung volume reduction surgery, segmentectomy, lobectomy or pneumonectomy
- History of a thoracotomy
- Symptomatic Benign prosthetic hypertrophy
- Symptomatic bladder outlet obstruction
- Symptomatic glaucoma
- Severe COPD defined as a postbronchodilator FEV1/FVC ratio of < 0.7 and a predicted FEV1 of 30-50%. Very severe COPD defined as a postbronchodilator FEV1/FVC ratio of <0.7 and a predicted FEV1 of < 30%. (Eur Respir J 2004; 23: 932-946).
- Within the previous one month (30 days) prior to beginning the study, used or continue to use ipratropium or tiotropium
- Allergic response or history of allergy to lactose
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870896
Locations
| United States, Florida | |
| University of South Florida (COPH) | |
| Tampa, Florida, United States, 33612 | |
| James A Haley Veterans' Hospital | |
| Tampa, Florida, United States, 33612 | |
Sponsors and Collaborators
University of South Florida
Boehringer Ingelheim Pharmaceuticals
Investigators
| Principal Investigator: | Thoms Truncale, DO,MPH | University of South Florida |
More Information
Publications:
CIBA Guest symposium Report. Terminology, definitions and classifications of chronic pulmonary emphysema and related conditions. Thorax 1959; 14: 286-289.
Celli BR, Snider GL, Heffner J, Tiep B, et al. Standards for the Diagnosis and Care of Patients with Chronic Obstructive Pulmonary Disease. AJRCCM 1995; 152(5)(Pt 2): S78-S83.
American Thoracic Society: Guidelines for Methacholine and Exercise Challenge Testing AJRCCM 2000; 161(1): 309-329.
| Responsible Party: | Debbie Ham, Boeringher Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00870896 History of Changes |
| Other Study ID Numbers: | P65201, 0800000250 V10 |
| Study First Received: | March 25, 2009 |
| Last Updated: | March 25, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of South Florida:
|
capsaicin COPD COPD with chronic bronchitis |
Additional relevant MeSH terms:
|
Bronchitis Bronchitis, Chronic Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchial Diseases Respiratory Tract Diseases Respiratory Tract Infections Tiotropium Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013