Pulmonary Disease, Chronic ObstructivePhase 3NCT02172300

Effect of Tiotropium on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Tiotropium inhalation capsules in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study to investigate whether tiotropium therapy can increase duration of steady-state exercise by decreasing dynamic and static lung hyperinflation in COPD patients. Read more about this study

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium inhalation capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 198 participants
Where: No sites listed yet
Study dates: Jun 1999to Nov 2000
Phase: Phase 3
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 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients had to have a diagnosis of COPD. Patients had to meet the following spirometric and static lung volume criteria:
Patients had to have relatively stable, mild (stage I according to the criteria of the American Thoracic Society (ATS); original trial protocol: moderate) to severe airway obstruction with an FEV1 less than or equal to 65% of predicted values. All patients had to have presence of lung hyperinflation as demonstrated by thoracic gas volume (TGV) / functional residual capacity (FRC) greater than or equal to 120% of predicted value as determined by body plethysmography at Visit 1 (day -15).
Male or female patients ≥ 40 but ≤ 70 years old.
Patients had to have a cigarette smoking history of more than 10 pack-years. A pack-year was defined as the equivalent of smoking one pack of cigarettes per day for a year.
Patients had to be able to perform all specified procedures and maintain records during the study period as required in the protocol.
Patients had to be able to inhale medication from the HandiHaler®.
All patients had to sign an Informed Consent Form in accordance with Good Clinical Practice (GCP) and local legislative requirements prior to participation in the trial . i.e., prior to pre-study washout of their usual pulmonary medications.

Who cannot join

Patients with significant diseases other than COPD were to be excluded. A significant disease was defined either as a disease, which in the opinion of the investigator might have put the patient at risk because of participation in the study or a disease, which might have influenced the results of the study or the patient's ability to participate in the study.
Patients with clinically significant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defined a disease listed as an exclusion criterion, the patient was to be excluded.
All patients with a serum glutamic oxaloacetic transaminase (SGOT or AST) ≥ 1.5 of the upper limit of normal range (x ULN), serum glutamic pyruvic transaminase (SGPT or ALT) ≥ 1.5 x ULN, bilirubin ≥ 1.5 x ULN, or creatinine ≥ 1.5 x ULN were excluded regardless of the clinical condition. Repeat laboratory evaluation was not to be conducted in these subjects.
Patients with a recent history (i.e., 1 year or less) of myocardial infarction.
Patients with a recent history (i.e., 3 years or less) of heart failure, pulmonary edema, or patients with cardiac arrhythmia (with or without symptoms) or any contraindication to exercise as indicated in Protocol Appendix four (see Section 9.5.1 and Appendices 16.1.1.1 and 16.1.1.2).
Patients with regular use of daytime oxygen therapy. (In centers with significantly decreased barometric pressure, exercise tests can be done with inhaled oxygen).

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Patients with known active tuberculosis.
Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were allowed.
Patients with a history of life-threatening pulmonary obstruction or a history of cystic fibrosis or bronchiectasis.
Patients who had undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reason were to be evaluated as per exclusion criterion No. 1.
Patients with upper respiratory tract infection in the past 6 weeks prior to the Screening visit (Visit 1, day -15) or during the run-in period.
Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
Patients with known narrow-angle glaucoma.
Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600/mm3. A repeat eosinophil count was not to be conducted in these patients.
Patients who were being treated with cromolyn sodium or nedocromil sodium had to stop these medications 1 month before Visit 1 (day -15).
Patients who were being treated with antihistamines (H1 receptor antagonists) or antileukotrienes had to stop these medications 1 month before Visit 1 (day -15).
Patients using oral corticosteroid medication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm or Norplant®).
Patients with history or active alcohol or drug abuse.
Patients who had taken an investigational drug within 1 month or 10 half lives (whichever was greater) prior to Screening visit (Visit 1, day -15).
Limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea such as arthritis in the leg, angina or claudication.
Patients who participated in any rehabilitation program for COPD within 6 weeks prior to Visit 1 (day -15).

About this study

Official title: Effect of Tiotropium on Exercise Tolerance and Static and Dynamic Lung Volumes in COPD Patients (A Randomized Double-Blind, Placebo Controlled, Parallel Group Study)

Study to investigate whether tiotropium therapy can increase duration of steady-state exercise by decreasing dynamic and static lung hyperinflation in COPD patients.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium inhalation capsules, Placebo inhalation capsules
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tiotropium inhalation capsulesDrug
Placebo inhalation capsulesDrug

Study groups in NCT02172300
Study group	Role	What they receive
Tiotropium	Experimental	Tiotropium inhalation capsules via HandiHaler Receives: Drug: Tiotropium inhalation capsules
Placebo	Placebo comparator	Placebo inhalation capsules via HandiHaler Receives: Drug: Placebo inhalation capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of submaximal exercise tolerance (as measured by endurance time during a constant work rate exercise test to symptom limitation)
Measured: Day 42

Secondary outcomes (21)

Endurance time after first dosing
Measured: Day 0 and 21
Determination of breathlessness (dyspnea) during constant work rate exercise test as measured by the modified Borg Scale
Measured: Day -10, -5, 0, 21 and 42
Determination of leg discomfort during constant work rate exercise test as measured by the modified Borg Scale
Measured: Day -10, -5, 0, 21 and 42
Evaluation of dynamic lung hyperinflation during exercise
Measured: Day -10, -5, 0, 21 and 42
Evaluation of dynamic hyperinflation (DH) as negative change in inspiratory capacity (IC) from rest
Measured: Day -10, -5, 0, 21 and 42
Evaluation of static lung hyperinflation
Measured: Day -10, -5, 0, 21 and 42
Evaluation of TAV (Trapped air volume) at rest
Measured: Day -10, -5, 0, 21 and 42
Evaluation of slow vital capacity (SVC)
Measured: Day -10, -5, 0, 21, 42 and 56
Evaluation of FEV1 (Forced expiratory volume in one second)
Measured: Day -10, -5, 0, 21 and 42
Evaluation of forced vital capacity (FVC)
Measured: Day -10, -5, 0, 21 and 42
Evaluation of forced expiratory flow rate between 25% and 75% of FVC which has been exhaled (FEF25-75%)
Measured: Day -10, -5, 0, 21 and 42
Evaluation of forced expiratory flow rate at 50% of FVC which has been exhaled (FEF50%)
Measured: Day -10, -5, 0, 21 and 42
Evaluation of forced expiratory flow rate at 75% of FVC which has been exhaled (FEF75%)
Measured: Day -10, -5, 0, 21 and 42
Evaluation of total lung capacity (TLC), airway resistance (Raw), and specific airway conductance (SGaw)
Measured: Day -10, -5, 0, 21 and 42
Evaluation of dyspnea using the Baseline Dyspnea Index (BDI) and Transition Dyspnoea Index (TDI)
Measured: Day 0, 21 and 42
Determination of arterial oxygen saturation (SaO2), oxygen consumption (VO2), tidal volume (VT), breathing frequency (F), and minute ventilation (VE)
Measured: Day -10, -5, 0, 21 and 42
Physicians Global Assessment
Measured: Day 0 and 42
Evaluation of COPD symptom scores
Measured: Day 0, 21 and 42
Reason for stopping constant work rate exercise
Measured: Day -15, -10, -5, 0, 21 and 42
Rescue medication use during test days
Measured: Day -15, -10, -5, 0, 21 and 42
Rescue medication use as weekly mean for number of night-time puffs (Rescni,w), daytime puffs (Rescday,w) and total daily puffs (Resctot,w) of rescue medication
Measured: until week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 1999Nov 2000

First posted24 Jun 2014 (estimated)
Study startJun 1999
Primary completionNov 2000

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 198 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02172300
Sponsor's protocol ID: 205.131
Status last verified: Jun 2014
First submitted: 20 Jun 2014
Last updated: 24 Jun 2014
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Tiotropium on Exercise Tolerance and Static and Dynamic Lung Volumes in COPD Patients (A Randomized Double-Blind, Placebo Controlled, Parallel Group Study)
ClinicalTrials.gov ID: NCT02172300
Acronym / sponsor ID: 205.131
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 198 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jun 1999
Primary completion: Nov 2000 (actual)
First posted: 24 Jun 2014 (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.

Study to investigate whether tiotropium therapy can increase duration of steady-state exercise by decreasing dynamic and static lung hyperinflation in COPD patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Tiotropium	Experimental	Drug: Tiotropium inhalation capsulesTiotropium inhalation capsules via HandiHaler
Placebo	Placebo comparator	Drug: Placebo inhalation capsulesPlacebo inhalation capsules via HandiHaler

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

All patients had to have a diagnosis of COPD. Patients had to meet the following spirometric and static lung volume criteria:
Male or female patients ≥ 40 but ≤ 70 years old.
Patients had to have a cigarette smoking history of more than 10 pack-years. A pack-year was defined as the equivalent of smoking one pack of cigarettes per day for a year.
Patients had to be able to perform all specified procedures and maintain records during the study period as required in the protocol.
Patients had to be able to inhale medication from the HandiHaler®.

Key exclusion criteria (23 listed)

Patients with significant diseases other than COPD were to be excluded. A significant disease was defined either as a disease, which in the opinion of the investigator might have put the patient at risk because of participation in the study or a disease, which might have influenced the results of the study or the patient's ability to participate in the study.
Patients with clinically significant abnormal baseline hematology, blood chemistry or urinalysis. If the abnormality defined a disease listed as an exclusion criterion, the patient was to be excluded.
All patients with a serum glutamic oxaloacetic transaminase (SGOT or AST) ≥ 1.5 of the upper limit of normal range (x ULN), serum glutamic pyruvic transaminase (SGPT or ALT) ≥ 1.5 x ULN, bilirubin ≥ 1.5 x ULN, or creatinine ≥ 1.5 x ULN were excluded regardless of the clinical condition. Repeat laboratory evaluation was not to be conducted in these subjects.
Patients with a recent history (i.e., 1 year or less) of myocardial infarction.
Patients with a recent history (i.e., 3 years or less) of heart failure, pulmonary edema, or patients with cardiac arrhythmia (with or without symptoms) or any contraindication to exercise as indicated in Protocol Appendix four (see Section 9.5.1 and Appendices 16.1.1.1 and 16.1.1.2).

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
Tiotropium inhalation capsules	Drug	Tiotropium
Placebo inhalation capsules	Drug	Placebo

Primary outcome

Evaluation of submaximal exercise tolerance (as measured by endurance time during a constant work rate exercise test to symptom limitation)
Time frame: Day 42

21 secondary outcomes

Endurance time after first dosing
Time frame: Day 0 and 21
Determination of breathlessness (dyspnea) during constant work rate exercise test as measured by the modified Borg Scale
Time frame: Day -10, -5, 0, 21 and 42
Determination of leg discomfort during constant work rate exercise test as measured by the modified Borg Scale
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of dynamic lung hyperinflation during exercise
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of dynamic hyperinflation (DH) as negative change in inspiratory capacity (IC) from rest
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of static lung hyperinflation
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of TAV (Trapped air volume) at rest
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of slow vital capacity (SVC)
Time frame: Day -10, -5, 0, 21, 42 and 56
Evaluation of FEV1 (Forced expiratory volume in one second)
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of forced vital capacity (FVC)
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of forced expiratory flow rate between 25% and 75% of FVC which has been exhaled (FEF25-75%)
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of forced expiratory flow rate at 50% of FVC which has been exhaled (FEF50%)
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of forced expiratory flow rate at 75% of FVC which has been exhaled (FEF75%)
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of total lung capacity (TLC), airway resistance (Raw), and specific airway conductance (SGaw)
Time frame: Day -10, -5, 0, 21 and 42
Evaluation of dyspnea using the Baseline Dyspnea Index (BDI) and Transition Dyspnoea Index (TDI)
Time frame: Day 0, 21 and 42
Determination of arterial oxygen saturation (SaO2), oxygen consumption (VO2), tidal volume (VT), breathing frequency (F), and minute ventilation (VE)
Time frame: Day -10, -5, 0, 21 and 42
Physicians Global Assessment
Time frame: Day 0 and 42
Evaluation of COPD symptom scores
Time frame: Day 0, 21 and 42
Reason for stopping constant work rate exercise
Time frame: Day -15, -10, -5, 0, 21 and 42
Rescue medication use during test days
Time frame: Day -15, -10, -5, 0, 21 and 42
Rescue medication use as weekly mean for number of night-time puffs (Rescni,w), daytime puffs (Rescday,w) and total daily puffs (Resctot,w) of rescue medication
Time frame: until week 6

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
Related InfoLink provided by the sponsor.

Related trials for Pulmonary Disease, Chronic Obstructive

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Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tiotropium inhalation capsules in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.

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 7 inclusion and 23 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: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of submaximal exercise tolerance (as measured by endurance time during a constant work rate exercise test to symptom limitation) (time frame: Day 42). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02172300.

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 24 Jun 2014.