ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01172925
Recruitment Status : Unknown
Verified May 2015 by John Goffin, McMaster University.
Recruitment status was:  Recruiting
First Posted : July 30, 2010
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
John Goffin, McMaster University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
NSCLC Dyspnea Drug: Tiotropium Drug: Placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer
Study Start Date : November 2010
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Tiotropium
Inhaler
 Drug: Tiotropium
Inhaler
Placebo Comparator: Placebo
Inhaler
 Drug: Placebo
Inhaler


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 12 question Cancer Dyspnea Scale [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. 10 point Dyspnea numeric scale [ Time Frame: 6 weeks ]
  2. 10 point Cough scale [ Time Frame: 6 weeks ]
  3. Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L) [ Time Frame: 6 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

  23. Unable to independently fill out quality of life forms or give informed consent.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01172925


Contacts
Contact: John Goffin, MD 905-387-9495 ext 64603 goffinj@hhsc.ca
Contact: Sherry McFarlan, RN 905-387-9495 ext 64407 smcfarla@hhsc.ca

Locations
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Sherry McFarlan, RN    905-387-9495 ext 64407    smcfarla@hhsc.ca   
Principal Investigator: John Goffin, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: John Goffin, MD Juravinski Cancer Centre and McMaster University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Juravinski Cancer Centre, Actively Accruing Clinical Trials  This link exits the ClinicalTrials.gov site

Responsible Party: John Goffin, Associate Prof, McMaster University
ClinicalTrials.gov Identifier: NCT01172925     History of Changes
Other Study ID Numbers: 2009-TIDAL
First Posted: July 30, 2010    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by John Goffin, McMaster University:
NSCLC
dyspnea
phase II
crossover
tiotropium

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Dyspnea
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
 Signs and Symptoms
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action