Pulmonary Disease, Chronic ObstructivePhase 3NCT02172391

Effect of Tiotropium on Airway Diameter in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Tiotropium inhalation powder 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

Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in COPD patients as measured by inspiratory capacity (IC). Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium inhalation powder capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: No sites listed yet
Study dates: Nov 2000to Aug 2001
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients must have a diagnosis of chronic obstructive pulmonary disease
Male or female patients ≥ 40 years of age but ≤ 75 years old
Patients must have a smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year
Patients must be able to perform all specified procedures and maintain records during the study period as required in the protocol
Patients must be able to inhale medication from the HandiHaler®
All patients must sign a Patient Informed Consent Form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications
Patients must be willing to attend an outpatient clinic on a regular basis
Patients must be able to walk 164 feet (50 meters) during the Six Minute Walk Test

Who cannot join

Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis test results, if the abnormality defines a disease listed as an exclusion criterion
Patients with a serum glutamic-oxaloacetic transaminase (SGOT) ≥1.5 x Upper Limit of Normal Range (ULN), serum glutamic-pyruvic transaminase (SGPT) ≥1.5 x ULN, bilirubin ≥1.5 x ULN or creatinine ≥ 1.5 x ULN regardless of the clinical condition
Patients with a recent history (i.e., one year or less) of myocardial infarction
Patients with a recent history (i.e., three years or less) of heart failure, pulmonary edema or patients with any cardiac arrhythmia (with or without symptoms)
Patients with regular use of daytime oxygen therapy

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Patients with known active tuberculosis
Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed
Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history or a thoracotomy for other reason should be evaluated as per exclusion criterion no. 1
Patients with upper respiratory tract infection in the past six weeks prior to the Screening Visit or during the baseline 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 who are being treated with cromolyn sodium or nedocromil sodium
Patients who are being treated with antihistamines (H1 receptor antagonists) or antileukotrienes and are not able to stop these medications 1 month before visit 1
Patients using oral corticosteroid medication at unstable doses (i.e., less than six 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
Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600/mm3
Patients with history of (past five years or less) and/or active alcohol or drug abuse
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Period (Visit 1)
Patients who have participated in any pulmonary rehabilitation program for COPD within 6 weeks prior to Visit 1 or throughout the study
Limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea such as arthritis in the leg, angina or claudication

About this study

Official title: The Effects of Tiotropium Therapy on Airway Diameter in Patients With COPD (a Randomized, Double-blind, Placebo-controlled, Parallel-group Study)

Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in COPD patients as measured by inspiratory capacity (IC).

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium inhalation powder capsules, Placebo inhalation powder 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 powder capsulesDrug
Placebo inhalation powder capsulesDrug

Study groups in NCT02172391
Study group	Role	What they receive
Tiotropium	Experimental	Tiotropium inhalation powder capsules 18 mcg, one capsule once daily for 28 days Receives: Drug: Tiotropium inhalation powder capsules
Placebo	Placebo comparator	Placebo inhalation powder capsules, one capsule once daily for 28 days Receives: Drug: Placebo inhalation powder capsules

What is being measured

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

Area under the curve from time 0 to 3 hours (AUC0-3) of resting inspiratory capacity (IC)
Measured: Day 28
Trough resting IC
Measured: Day 28

Secondary outcomes (21)

FEV1 (Forced expiratory volume in one second)
Measured: Day 1, 14 and 28
FVC (forced vital capacity)
Measured: Day 1, 14 and 28
FEF25%-75% (Forced Expiratory Flow, mid expiratory phase)
Measured: Day 1, 14 and 28
FEF50% (Forced Expiratory Flow, at 50% of FVC)
Measured: Day 1, 14 and 28
FEF75% (Forced Expiratory Flow, at 75% of FVC)
Measured: Day 1, 14, 28
SVC (Slow vital capacity)
Measured: Day 1, 14, 28
Respiratory System Transfer Impedance (Respiratory Resistance)
Measured: Day 1, 14 and 28
Airway Resistance (Raw)
Measured: Day 1, 14 and 28
Thoracic Gas Volume (TGV)
Measured: Day 1, 14 and 28
Specific Airway Conductance (SGaw)
Measured: Day 1, 14 and 28
Physician's Global Evaluation
Measured: Day 1 and 28
Oxygen Saturation (SaO2) prior to six minute walk test
Measured: Day 1 and 28
Oxygen Saturation (SaO2) post six minute walk test
Measured: Day 1 and 28
IC prior to six minute walk test
Measured: Day 1 and 28
IC post six minute walk test
Measured: Day 1 and 28
Chronic Respiratory Questionnaire (CRQ)
Measured: Day 1 and 28
Baseline Dyspnea Index (BDI)
Measured: Day 1
Transition Dyspnea Index (TDI)
Measured: Day 28
Change from baseline in seated blood pressure
Measured: Baseline, Day 1, 14 and 28
Change from baseline in pulse rate
Measured: Baseline, Day 1, 14 and 28
Occurrence of Adverse Events
Measured: until day 35

Timeline

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

Nov 2000Aug 2001

First posted24 Jun 2014 (estimated)
Study startNov 2000
Primary completionAug 2001

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
Enrolment: 81 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT02172391
Sponsor's protocol ID: 205.218
Status last verified: Aug 2018
First submitted: 20 Jun 2014
Last updated: 31 Aug 2018
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

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Tiotropium Therapy on Airway Diameter in Patients With COPD (a Randomized, Double-blind, Placebo-controlled, Parallel-group Study)
ClinicalTrials.gov ID: NCT02172391
Acronym / sponsor ID: 205.218
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2000
Primary completion: Aug 2001 (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.

Trial to investigate the acute and chronic effect of tiotropium therapy on airway diameter in COPD patients as measured by inspiratory capacity (IC).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Tiotropium	Experimental	Drug: Tiotropium inhalation powder capsulesTiotropium inhalation powder capsules 18 mcg, one capsule once daily for 28 days
Placebo	Placebo comparator	Drug: Placebo inhalation powder capsulesPlacebo inhalation powder capsules, one capsule once daily for 28 days

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

All patients must have a diagnosis of chronic obstructive pulmonary disease
Male or female patients ≥ 40 years of age but ≤ 75 years old
Patients must have a smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year
Patients must be able to perform all specified procedures and maintain records during the study period as required in the protocol
Patients must be able to inhale medication from the HandiHaler®

Key exclusion criteria (23 listed)

Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis test results, if the abnormality defines a disease listed as an exclusion criterion
Patients with a serum glutamic-oxaloacetic transaminase (SGOT) ≥1.5 x Upper Limit of Normal Range (ULN), serum glutamic-pyruvic transaminase (SGPT) ≥1.5 x ULN, bilirubin ≥1.5 x ULN or creatinine ≥ 1.5 x ULN regardless of the clinical condition
Patients with a recent history (i.e., one year or less) of myocardial infarction
Patients with a recent history (i.e., three years or less) of heart failure, pulmonary edema or patients with any cardiac arrhythmia (with or without symptoms)

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 powder capsules	Drug	Tiotropium
Placebo inhalation powder capsules	Drug	Placebo

Primary outcome

Area under the curve from time 0 to 3 hours (AUC0-3) of resting inspiratory capacity (IC)
Time frame: Day 28
Trough resting IC
Time frame: Day 28

21 secondary outcomes

FEV1 (Forced expiratory volume in one second)
Time frame: Day 1, 14 and 28
FVC (forced vital capacity)
Time frame: Day 1, 14 and 28
FEF25%-75% (Forced Expiratory Flow, mid expiratory phase)
Time frame: Day 1, 14 and 28
FEF50% (Forced Expiratory Flow, at 50% of FVC)
Time frame: Day 1, 14 and 28
FEF75% (Forced Expiratory Flow, at 75% of FVC)
Time frame: Day 1, 14, 28
SVC (Slow vital capacity)
Time frame: Day 1, 14, 28
Respiratory System Transfer Impedance (Respiratory Resistance)
Time frame: Day 1, 14 and 28
Airway Resistance (Raw)
Time frame: Day 1, 14 and 28
Thoracic Gas Volume (TGV)
Time frame: Day 1, 14 and 28
Specific Airway Conductance (SGaw)
Time frame: Day 1, 14 and 28
Physician's Global Evaluation
Time frame: Day 1 and 28
Oxygen Saturation (SaO2) prior to six minute walk test
Time frame: Day 1 and 28
Oxygen Saturation (SaO2) post six minute walk test
Time frame: Day 1 and 28
IC prior to six minute walk test
Time frame: Day 1 and 28
IC post six minute walk test
Time frame: Day 1 and 28
Chronic Respiratory Questionnaire (CRQ)
Time frame: Day 1 and 28
Baseline Dyspnea Index (BDI)
Time frame: Day 1
Transition Dyspnea Index (TDI)
Time frame: Day 28
Change from baseline in seated blood pressure
Time frame: Baseline, Day 1, 14 and 28
Change from baseline in pulse rate
Time frame: Baseline, Day 1, 14 and 28
Occurrence of Adverse Events
Time frame: until day 35

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 31 Aug 2018.

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
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.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

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 powder 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 8 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 31 Aug 2018. 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?

Area under the curve from time 0 to 3 hours (AUC0-3) of resting inspiratory capacity (IC) (time frame: Day 28). The study lists 2 primary outcomes in all. 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 NCT02172391.

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 31 Aug 2018.