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Pulmonary Disease, Chronic ObstructivePhase 3NCT02172456

Evaluation of the Lung Deposition Rate and Distribution Pattern of Tiotropium Via HandiHalerTM in Healthy Subjects and Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing 99mTc-radiolabelled tiotropium and non-radiolabelled tiotropium 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

Primary endpoint: whole lung deposition and in-vivo distribution pattern of a 99mTc-labelled tiotropium powder formulation following inhalation via HandiHalerTM in healthy subjects as well as in patients with mild, moderate and severe COPD Secondary endpoints: pharmacokinetics, pharmacodynamics (effect on lung… Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
99mTc-radiolabelled tiotropium and non-radiolabelled tiotropium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
No sites listed yet
Study dates
May 2002to Oct 2002
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • for healthy subjects and COPD patients:
  • Males or females 40 years of age or older.
  • Subjects/Patients must be able to inhale medication from the HandiHalerTM
  • Subjects/Patients must be able to perform all study-related tests including acceptable pulmonary function tests, and must be able to maintain records during the study period as required in the protocol.
  • All subjects/patients must sign an Informed Consent Form prior to participation in the trial in accordance with ICH-GCP and the local legislation, i.e., the COPD patients must give written informed consent prior to pre-study washout of their usual pulmonary medications.
  • for healthy subjects:
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  • Normal spirometry as evidenced by a baseline FEV1 ≥ 80 % of predicted normal value for age, height and sex, and FEV1 ≥ 70% of FVC
  • Lifelong non-smokers or ex-smokers with a non-smoking period of at least five years and a maximum of five pack-years.
  • for COPD patients:
  • All patients must have a diagnosis of relatively stable chronic obstructive pulmonary disease and must fulfil the spirometric criteria of the respective sub-group:
  • Mild COPD: 50% ≤ FEV1 < 70% of predicted normal; FEV1/FVC < 70%.
  • Moderate COPD: 35% ≤ FEV1 < 50% of predicted normal; FEV1/FVC < 70%.
  • Severe COPD: FEV1 < 35% of predicted normal; FEV1/FVC < 70%.

Who cannot join

  • for healthy subjects and COPD patients:
  • Subjects or patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded.
  • All subjects/patients with serum glutamic-oxaloacetic transaminase (SGOT) > 80 IU/L, serum glutamic-pyruvic transaminase (SGPT) > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these subjects/patients.
  • Subjects/Patients with a recent history (i.e., one year or less) of myocardial infarction.
  • Subjects/Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
  • Subjects/Patients with known active tuberculosis.
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  • Subjects/Patients with a history of cancer within the last five years.
  • Subjects/Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
  • Subjects/Patients who have undergone thoracotomy with pulmonary resection.
  • Patients with any upper respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period
  • Subjects/Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system
  • Subjects/Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction.
  • Subjects/Patients with known narrow-angle glaucoma.
  • Subjects/Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥ 600 mm3. A repeat eosinophil count will not be conducted in these subjects/patients.
  • Subjects/Patients with a history of and/or active significant alcohol or drug abuse.
  • Subjects/Patients who have taken an investigational drug within one month or six half lives (whichever is shorter) prior to Screening Visit (Visit 1).
  • In addition, for female subjects/patients:
  • Pregnancy.
  • Positive pregnancy test.
  • No adequate contraception, e.g. oral contraceptives, sterilisation, intra uterine device (IUD).
  • Inability to maintain this adequate contraception during the whole study period.
  • Lactation period.
  • for healthy subjects:
  • Subjects with any significant disease will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study or a disease which may influence the results of the study or the subject's ability to participate in the study.
  • Use of any drugs which might influence the results of the trial (within one week prior to administration or during the trial).
  • for COPD patients:
  • 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.
  • COPD patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
  • Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six week prior to the Screening Visit (Visit 1)
  • Patients who are being treated with oral beta adrenergics or long-acting beta adrenergics such as salmeterol and formoterol.
  • Patients who are being treated with beta blockers.
  • Patients who are being treated with antileukotrienes.
  • Patients who are being treated with cromolyn sodium or nedocromil sodium.
  • Patients who are being treated with antihistamines (H1-receptor antagonists).
  • Patients using oral corticosteroid medication at unstable doses (i.e., less than four weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.
  • Patients who are being treated with monoamine oxidase inhibitors or tricyclic antidepressants.
  • Patients with no adequate wash-out period of those medications specified in Section 4.2.2 of the study protocol.

About this study

Official title: γ-Scintigraphic Evaluation of the Lung Deposition Rate and Distribution Pattern of a 99mTc-Labelled Tiotropium Powder Formulation Following Multiple Dose Inhalation of Tiotropium Via HandiHalerTM in Healthy Subjects and Patients With COPD

Primary endpoint: whole lung deposition and in-vivo distribution pattern of a 99mTc-labelled tiotropium powder formulation following inhalation via HandiHalerTM in healthy subjects as well as in patients with mild, moderate and severe COPD

Secondary endpoints: pharmacokinetics, pharmacodynamics (effect on lung function), safety and tolerability

Being tested
99mTc-radiolabelled tiotropium, non-radiolabelled tiotropium
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.

  • 99mTc-radiolabelled tiotropiumDrug

  • non-radiolabelled tiotropiumDrug

Study groups in NCT02172456
Study groupRoleWhat they receive
TiotropiumExperimentalNot described
Receives: Drug: 99mTc-radiolabelled tiotropium; Drug: non-radiolabelled tiotropium

What is being measured

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

  1. Percentage of the total administered radioactivity of 99mTc-labelled tiotropium

    Measured: Day 15

Secondary outcomes (21)

  1. Peak plasma concentration at steady state (Cmax,ss)

    Measured: Day 14

  2. Time to peak plasma concentration at steady state (Tmax,ss)

    Measured: Day 14

  3. Pre-dose plasma concentration (Cpre)

    Measured: Day 1

  4. Area under the curve from 0 to 4 hours at steady state (AUCss,0-4h )

    Measured: Day 14: 5, 10, 20 min, 1, 2, 4 hours after dosing

  5. Renal clearance (CLr)

    Measured: Day 14: 0-4 hours and 4-8 hours after drug administration

  6. Drug concentration (C20min)

    Measured: Day 15: 20 min after drug administration

  7. Drug concentration (C2h)

    Measured: Day 15: 2 hours after drug administration

  8. Change from baseline in forced expiratory volume in the first second (FEV1) in healthy subjects

    Measured: Baseline (day -14), day 15 (pre-dose)

  9. Change from baseline in forced Vital Capacity (FVC) in healthy subjects

    Measured: Baseline (day -14), day 15 (pre-dose)

  10. Number of adverse events

    Measured: up to day 38

  11. Change from baseline in puls rate

    Measured: Baseline, day 28

  12. Change from baseline in blood pressure

    Measured: Baseline, day 28

  13. Change from baseline in laboratory tests

    Measured: Baseline, day 28

  14. Change from baseline in 12 lead electrocardiogram (ECG)

    Measured: Baseline, day 28

  15. Change from baseline in physical examination

    Measured: Baseline, day 28

  16. Change from baseline in forced expiratory volume in the first second (FEV1) in COPD patients

    Measured: Baseline (day -14), pre-dose on day 1, 9, 14 (pre-dose and 0.5, 1, 2, and 3 hours after dosing), 15 and 28

  17. Change from baseline in forced Vital Capacity (FVC) in COPD patients

    Measured: Baseline (day -14), pre-dose on day 1, 9, 14 (pre-dose and 0.5, 1, 2, and 3 hours after dosing), 15 and 28

  18. Pre-dose plasma concentration in steady state (Cpre,ss)

    Measured: day 9, 14, 15

  19. Area under the curve from 0 to 8 hours at steady state (AUCss,0-8h )

    Measured: Day 14: 5, 10, 20 min, 1, 2, 4, 8 hours after dosing

  20. Amount excreted into urine from 0 to 4 hours (Aess,0-4h)

    Measured: Day 14: 0-4 hours, day 15: 0-4 hours

  21. Amount excreted into urine from 0 to 8 hours (Aess,0-8h)

    Measured: Day 14: 0-8 hours, day 15: 0-8 hours

Timeline

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

  1. First posted24 Jun 2014 (estimated)
  2. Study startMay 2002
  3. Primary completionOct 2002

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02172456
Sponsor's protocol ID
205.238
Status last verified
Jun 2014
First submitted
20 Jun 2014
Last updated
24 Jun 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 99mTc-radiolabelled tiotropium and non-radiolabelled tiotropium 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 13 inclusion and 37 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. 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?

Percentage of the total administered radioactivity of 99mTc-labelled tiotropium (time frame: Day 15). 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 NCT02172456.

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.

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