Trial · NCT00870896
The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00870896, Early phase 1, Completed, ThomasTruncale; results first posted 2014-09-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease (COPD). Trials, record NCT00870896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00870896
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- NCT number
- NCT00870896
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 5 participants, actual
- Lead sponsor
- ThomasTruncale
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Bronchitis
- Interventions
- Tiotropium
- First posted
- 2009-03-27
- Last updated
- 2014-10-01
- Results first posted
- 2014-09-15
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Change in FEV1 (in Liters) | 30 days | Change in FEV1 ( in liters) at baseline and following 30 days of treatment with Spiriva |
| Secondary | 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 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Coughs Following Capsaicin Inhalation Challenge at Baseline and Following 30 Days of Treatment With Spiriva (Baseline and 30 Days) | 30 days | 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. | coughs per dose of capsaicin | MEAN |
| SECONDARY | Change in FEV1 (in Liters) | 30 days | 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. | liters | MEAN |
| SECONDARY | Change in FEV1/FVC Ratio | 30 days | percentage change | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Coughs Following Capsaicin Inhalation Challenge at Baseline and Following 30 Days of Treatment With Spiriva (Baseline and 30 Days) | Group 1 | 2.5 | Standard Deviation 2.75 | coughs per dose of capsaicin | |
| Change in FEV1 (in Liters) | Spirometry | .315 | Standard Deviation 138 | liters | |
| Change in FEV1/FVC Ratio | Change in FEV1/FVC | 3 | Standard Deviation 5.74 | percentage change |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 | 5 | |
| Overall Study | COMPLETED | Group 1 | 5 | |
| Overall Study | NOT COMPLETED | Group 1 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tiotropium | ||
| Total, other adverse events | Tiotropium | 0 | 5 |
| Total, serious adverse events | Tiotropium | 0 | 5 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00870896
GET https://conductscience.org/api/trials/v1/NCT00870896/registered