NSCLCPhase 2TIDALNCT01172925
Study of a Tiotropium Inhaler For Shortness of Breath in Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Tiotropium in people with NSCLC and Dyspnea, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Aug 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Sherry McFarlan, RN, 905-387-9495 ext. 64407, smcfarla@hhsc.ca
John Goffin, MD
About this study
Official title: Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer
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.
- Being tested
- Tiotropium, Placebo
- Keywords
- NSCLC, dyspnea, phase II, crossover, tiotropium
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiotropiumDrug
Inhaler
PlaceboDrug
Inhaler
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium | Experimental | Inhaler Receives: Drug: Tiotropium |
| Placebo | Placebo comparator | Inhaler Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 question Cancer Dyspnea Scale
Measured: 6 weeks
Secondary outcomes (3)
10 point Dyspnea numeric scale
Measured: 6 weeks
10 point Cough scale
Measured: 6 weeks
Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Goffin, McMaster University
- Investigators
- John Goffin, MD, Principal investigator, Juravinski Cancer Centre and McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172925
- Sponsor's protocol ID
- 2009-TIDAL
- Acronym
- TIDAL
- Status last verified
- May 2015
- First submitted
- 22 Jul 2010
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01172925
- Acronym / sponsor ID
- TIDAL / 2009-TIDAL
- Keywords
- NSCLC, dyspnea, phase II, crossover, tiotropium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium | Experimental | Drug: TiotropiumInhaler |
| Placebo | Placebo comparator | Drug: PlaceboInhaler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiotropiumInhaler | Drug | Tiotropium |
| PlaceboInhaler | Drug | Placebo |
Primary outcome
12 question Cancer Dyspnea Scale
Time frame: 6 weeks
3 secondary outcomes
10 point Dyspnea numeric scale
Time frame: 6 weeks
10 point Cough scale
Time frame: 6 weeks
Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Goffin, MD principal investigator
Juravinski Cancer Centre and McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiotropium in people with NSCLC and Dyspnea, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Goffin, MD (905-387-9495 ext. 64603, goffinj@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 question Cancer Dyspnea Scale (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.