CompletedNCT00870896Updated Oct 1, 2014Results posted

The Effects of Tiotropium on the Cough Reflex in Patients With Chronic Obstructive Pulmonary Disease (COPD)

An Early Phase 1 interventional study of Tiotropium in Chronic Obstructive Pulmonary Disease and Chronic Bronchitis, sponsored by ThomasTruncale. Completed at 2 sites in United States. Open to male participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by ThomasTruncale · Early Phase 1, Interventional, and Treatment

Phase: Early Phase 1
Study type: Interventional
Enrollment: 5
Allocation: Not applicable
Ages: 40 Years to 80 Years
Sex: Male

Study summary

Does tiotropium effect the cough reflex in patients with COPD and chronic bronchitis.

Read the 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.

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

Conditions studied

Chronic Obstructive Pulmonary Disease
Chronic Bronchitis

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Keywords

capsaicin
COPD
COPD with chronic bronchitis

In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

This study's enrollment of 5 is below the median of 120 across 184 interventional studies indexed under Bronchitis.

Browse Bronchitis studies →

Lead sponsor

This is the only study on the registry with ThomasTruncale as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 80 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Eligibility 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

Study design

Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 5 participants (actual)

Study arms

Experimental
Tiotropium
Cough reflex measured by capsaicin Inhalation Challenge will follow Dicpinigaitis performed at 1 and 3 months. Solutions prepared to make a stock solution of 0.01 Mol diluted with physiologic saline to yield 11 doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Then, place 1 ml of the first concentration into nebulizer. Subjects inhale single breath of capsaicin aerosol. Single breaths are delivered in ascending order, with normal saline randomly interspersed to increase blindness, until two or more coughs (C2) and five or more coughs (C5) are reached. The different concentrations are delivered at 2 minute intervals.
Drug: Tiotropium

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.
Also known as: Spiriva

What researchers measure

Primary outcomes

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

Secondary outcomes

Change in FEV1 (in Liters)
Change in FEV1 ( in liters) at baseline and following 30 days of treatment with Spiriva
Time frame: 30 days
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

Results

Posted Sep 15, 2014

Participant flow

10/14/08 to 2/5/09

Participant flow — Overall Study
Milestone	Group 1
Started	5
Completed	5
Not completed	0

Outcome measures

PrimaryNumber 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
Reported as:: Mean · coughs per dose of capsaicin

Number of Coughs Following Capsaicin Inhalation Challenge at Baseline and Following 30 Days of Treatment With Spiriva (Baseline and 30 Days)
coughs per dose of capsaicin	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 ± 2.75

SecondaryChange in FEV1 (in Liters)

Change in FEV1 ( in liters) at baseline and following 30 days of treatment with Spiriva

Time frame:: 30 days
Reported as:: Mean · liters

Change in FEV1 (in Liters)
liters	Spirometry
Change in FEV1 (in Liters)	.315 ± 138

SecondaryChange 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
Reported as:: Mean · percentage change

Change in FEV1/FVC Ratio
percentage change	Change in FEV1/FVC
Change in FEV1/FVC Ratio	3 ± 5.74

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Tiotropium	—	0/5 (0%)	0/5 (0%)

Baseline characteristics

Twenty male subjects between 40-80 years of age with COPD will be recruited from the USF and James A. Haley medical clinics, word of mouth, newspaper and radio advertising. We are restricting the study to men because woman have a more sensitive cough reflex and analysis of data will be more difficult when comparing as a group.

Age, Categorical
Age, Categorical(Participants)	Tiotropium
<=18 years	0
Between 18 and 65 years	5
>=65 years	0

Age, Continuous
Age, Continuous(years)	Tiotropium
Mean	56 ± 4.52

Sex: Female, Male
Sex: Female, Male(Participants)	Tiotropium
Female	0
Male	5

Region of Enrollment
Region of Enrollment(participants)	Tiotropium
United States	5

Study locations

2 sites

James A Haley Veterans' Hospital
Tampa, Florida 33612, United States
University of South Florida (COPH)
Tampa, Florida 33612, United States

References and documents

Publications

Celli BR, MacNee W; ATS/ERS Task Force. Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004 Jun;23(6):932-46. doi: 10.1183/09031936.04.00014304. No abstract available. Erratum In: Eur Respir J. 2006 Jan;27(1):242. PubMed 15219010 ↗
CIBA Guest symposium Report. Terminology, definitions and classifications of chronic pulmonary emphysema and related conditions. Thorax 1959; 14: 286-289.
Standards for the diagnosis and care of patients with chronic obstructive pulmonary disease. American Thoracic Society. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 2):S77-121. No abstract available. PubMed 7582322 ↗
Doherty MJ, Mister R, Pearson MG, Calverley PM. Capsaicin responsiveness and cough in asthma and chronic obstructive pulmonary disease. Thorax. 2000 Aug;55(8):643-9. doi: 10.1136/thorax.55.8.643. PubMed 10899239 ↗
Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339. PubMed 12668799 ↗
Sekizawa K, Jia YX, Ebihara T, Hirose Y, Hirayama Y, Sasaki H. Role of substance P in cough. Pulm Pharmacol. 1996 Oct-Dec;9(5-6):323-8. doi: 10.1006/pulp.1996.0042. PubMed 9232670 ↗
Szallasi A, Blumberg PM. Vanilloid (Capsaicin) receptors and mechanisms. Pharmacol Rev. 1999 Jun;51(2):159-212. No abstract available. PubMed 10353985 ↗
Midgren B, Hansson L, Karlsson JA, Simonsson BG, Persson CG. Capsaicin-induced cough in humans. Am Rev Respir Dis. 1992 Aug;146(2):347-51. doi: 10.1164/ajrccm/146.2.347. PubMed 1489123 ↗
Fujimura M, Sakamoto S, Kamio Y, Matsuda T. Effects of methacholine induced bronchoconstriction and procaterol induced bronchodilation on cough receptor sensitivity to inhaled capsaicin and tartaric acid. Thorax. 1992 Jun;47(6):441-5. doi: 10.1136/thx.47.6.441. PubMed 1386691 ↗
Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available. PubMed 10619836 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00870896
Lead sponsor: ThomasTruncale
Collaborators: Boehringer Ingelheim
Responsible party: ThomasTruncale (Associate porfessor, University of South Florida) — Sponsor-investigator
First posted: Mar 27, 2009
Start date: Feb 2008
Primary completion: Feb 2009
Completion: Jun 2012
Results posted: Sep 15, 2014
Last update: Oct 1, 2014

Study contacts

Thoms Truncale, DO,MPH

principal investigator · University of South Florida

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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