Trial record 9 of 75 for:
Open Studies | "Dyspnea"
Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer (TIDAL)
This study is currently recruiting participants.
Verified November 2013 by McMaster University
Information provided by (Responsible Party):
John Goffin, McMaster University
First received: July 22, 2010
Last updated: November 11, 2013
Last verified: November 2013
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.
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer
Primary Outcome Measures:
- 12 question Cancer Dyspnea Scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 10 point Dyspnea numeric scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- 10 point Cough scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2014 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01172925
|Juravinski Cancer Centre
|Hamilton, Ontario, Canada, L8V 5C2 |
|Contact: Heather Harris, RN 905-387-9495 ext 64407 firstname.lastname@example.org |
|Principal Investigator: John Goffin, MD |
Hamilton Health Sciences Corporation
||John Goffin, MD
||Juravinski Cancer Centre and McMaster University
No publications provided
||John Goffin, Associate Prof, McMaster University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 22, 2010
||November 11, 2013
||Canada: Health Canada
Keywords provided by McMaster University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents