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Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer (TIDAL)

Primary Purpose

NSCLC, Dyspnea

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Tiotropium

Placebo

About this trial

This is an interventional treatment trial for NSCLC focused on measuring NSCLC, dyspnea, phase II, crossover, tiotropium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer.
Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2).
New dyspnea or worsening dyspnea within the last 6 months per patient reporting.

Exclusion Criteria:

Age < 18.
An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator.
Life expectancy < 3 months.
Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure).
Myocardial infarction within the previous month.
Heart rate ≥ 120.
Active tuberculosis or tuberculosis receiving antibiotic therapy.
Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6).
Sensitivity to atropine.
Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease
Use of beta-adrenergic bronchodilators more than once per week.
Use of experimental therapy with known cholinergic or adrenergic effects.
Uncontrolled glaucoma.
Urinary retention.
An active upper or lower respiratory infection or having taken antibiotics for any recent respiratory infection within 4 weeks.
Symptomatic pleural or pericardial effusion.
Evidence of reversible proximal endobronchial obstruction.
Oxygen saturation < 90%.
A hemoglobin of < 100 g/litre. Testing is to be within 4 weeks of randomization.
Calculated or urine creatinine clearance ≤ 50 mL/min (see Appendix 5 for calculation). Testing it to be within 4 weeks of randomization.
Weight loss > 10% of usual body weight within 6 months.
Known pregnancy or lactating.
Unable to independently fill out quality of life forms or give informed consent.
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Sites / Locations

Juravinski Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tiotropium

Placebo

Arm Description

Inhaler

Outcomes

Primary Outcome Measures

12 question Cancer Dyspnea Scale

Secondary Outcome Measures

10 point Dyspnea numeric scale

10 point Cough scale

Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L)

Full Information

NCT ID

NCT01172925

First Posted

July 22, 2010

Last Updated

May 22, 2015

Sponsor

Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01172925

Brief Title

Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer

Acronym

TIDAL

Official Title

Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

November 2010 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The feeling of shortness of breath is very common in lung cancer. It is uncomfortable for patients and upsetting for their family. Although drugs like morphine and oxygen can help some patients feel better, they don't help everybody, and they are not used in patients with early symptoms. More relief is needed for these patients. The investigators are studying a drug called tiotropium, which is used in emphysema. It is an inhaler that opens the airways to allow easier breathing. Every patient will get the drug but also a placebo, in a random (flip of a coin) order. They will get each for 2 weeks. The investigators will see if they feel better with the drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSCLC, Dyspnea

Keywords

NSCLC, dyspnea, phase II, crossover, tiotropium

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tiotropium

Arm Type

Experimental

Arm Description

Inhaler

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Inhaler

Intervention Type

Drug

Intervention Name(s)

Tiotropium

Intervention Description

Inhaler

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Inhaler

Primary Outcome Measure Information:

Title

12 question Cancer Dyspnea Scale

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

10 point Dyspnea numeric scale

Time Frame

6 weeks

Title

10 point Cough scale

Time Frame

6 weeks

Title

Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L)

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer. Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2). New dyspnea or worsening dyspnea within the last 6 months per patient reporting. Exclusion Criteria: Age < 18. An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator. Life expectancy < 3 months. Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure). Myocardial infarction within the previous month. Heart rate ≥ 120. Active tuberculosis or tuberculosis receiving antibiotic therapy. Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6). Sensitivity to atropine. Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease Use of beta-adrenergic bronchodilators more than once per week. Use of experimental therapy with known cholinergic or adrenergic effects. Uncontrolled glaucoma. Urinary retention. An active upper or lower respiratory infection or having taken antibiotics for any recent respiratory infection within 4 weeks. Symptomatic pleural or pericardial effusion. Evidence of reversible proximal endobronchial obstruction. Oxygen saturation < 90%. A hemoglobin of < 100 g/litre. Testing is to be within 4 weeks of randomization. Calculated or urine creatinine clearance ≤ 50 mL/min (see Appendix 5 for calculation). Testing it to be within 4 weeks of randomization. Weight loss > 10% of usual body weight within 6 months. Known pregnancy or lactating. Unable to independently fill out quality of life forms or give informed consent. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

John Goffin, MD

Phone

905-387-9495

Ext

64603

goffinj@hhsc.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Sherry McFarlan, RN

Phone

905-387-9495

Ext

64407

smcfarla@hhsc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Goffin, MD

Organizational Affiliation

Juravinski Cancer Centre and McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Juravinski Cancer Centre

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherry McFarlan, RN

Phone

905-387-9495

Ext

64407

smcfarla@hhsc.ca

First Name & Middle Initial & Last Name & Degree

John Goffin, MD

12. IPD Sharing Statement

Learn more about this trial

Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer

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