Chronic Bronchitis, Chronic Obstructive Pulmonary Disease
Conditions
Keywords
capsaicin, COPD, COPD with chronic bronchitis
Brief summary
Does tiotropium effect the cough reflex in patients with COPD and chronic bronchitis.
Detailed description
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. 1. 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 2. 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 3. 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 4. 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 5. 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 6. 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 7. 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 8. 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 9. 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 10. 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
Interventions
DRUGTiotropium
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.
Sponsors
Boehringer Ingelheim
ThomasTruncale
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Coughs Following Capsaicin Inhalation Challenge at Baseline and Following 30 Days of Treatment With Spiriva (Baseline and 30 Days) | 30 days | We measured the change in the number of coughs following capsaicin inhalation challenge from baseline followed by 30 days of treatment with spiriva |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FEV1 (in Liters) | 30 days | Change in FEV1 ( in liters) at baseline and following 30 days of treatment with Spiriva |
| Change in FEV1/FVC Ratio | 30 days | We measured the change in FEV1/FVC ratio at baseline and following 30 days of treatment with Spiriva.Change in ratio reflects the percentage value (ratio) at 30 days minus the percentage value (ratio) at baseline x 100 |
Countries
United States
Participant flow
Recruitment details
10/14/08 to 2/5/09
Pre-assignment details
Unable to recruit 20 participates study stopped at 5
Participants by arm
| Arm | Count |
|---|---|
| Tiotropium Subjects 40-80 with \> 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age \< 40 or \> 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Tiotropium |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Age, Continuous | 56 years STANDARD_DEVIATION 4.52 |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Number of Coughs Following Capsaicin Inhalation Challenge at Baseline and Following 30 Days of Treatment With Spiriva (Baseline and 30 Days)
We measured the change in the number of coughs following capsaicin inhalation challenge from baseline followed by 30 days of treatment with spiriva
Time frame: 30 days
Population: Power two-sided t-test for C5. our previous studies coefficient of variation for C5 was 3.2%. We propose power 0.80/significance 0.05. multiple comparisons utilize Bonferroni procedure significance will be 0.017 ability to detect minimum difference of 3.7 uMol. Thus, if alpha 0.05 and beta 0.20, to detect difference require 20 subjects each group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Number of Coughs Following Capsaicin Inhalation Challenge at Baseline and Following 30 Days of Treatment With Spiriva (Baseline and 30 Days) | 2.5 coughs per dose of capsaicin | Standard Deviation 2.75 |
Secondary
Change in FEV1/FVC Ratio
We measured the change in FEV1/FVC ratio at baseline and following 30 days of treatment with Spiriva.Change in ratio reflects the percentage value (ratio) at 30 days minus the percentage value (ratio) at baseline x 100
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Change in FEV1/FVC Ratio | 3 percentage change | Standard Deviation 5.74 |
Secondary
Change in FEV1 (in Liters)
Change in FEV1 ( in liters) at baseline and following 30 days of treatment with Spiriva
Time frame: 30 days
Population: Power two-sided t-test for C5. our previous studies coefficient of variation for C5 was 3.2%. We propose power 0.80/significance 0.05. multiple comparisons utilize Bonferroni procedure significance will be 0.017 ability to detect minimum difference of 3.7 uMol. Thus, if alpha 0.05 and beta 0.20, to detect difference require 20 subjects each group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Change in FEV1 (in Liters) | .315 liters | Standard Deviation 138 |