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Pulmonary Disease, Chronic ObstructivePhase 3NCT02172326

Pharmacokinetic Study in Elderly Patients With Chronic Obstructive Bronchitis (COPD)

A Phase 3 study testing Tiotropium inhalation capsules for oral inhalation 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 evaluate the pharmacokinetics of tiotropium following 14 days of administration (18µg once per day) in elderly COPD patients. Read more about this study

Who is it for?
Any age
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Tiotropium inhalation capsules for oral inhalation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
No sites listed yet
Study dates
Feb 1998to Sep 1998
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • All patients were required to have a diagnosis of COPD and to meet the following spirometric criteria:
  • Relatively stable, moderate to severe airway obstruction with an FEV1 ≤ 65% of predicted normal and FEV1/FVC ≤ 70%
  • Patients were required to have normal renal clearance. Renal clearance will be evaluated by the determination of creatinine clearance. To qualify for this trial, the patient's measured creatinine clearance was required to be within 20% of the calculated creatinine clearance, as given by the following equations:
  • Males: Calculated Creatinine Clearance (ml/min) = [140 - Age (yrs)] x weight(kg) / 72 x serum creatinine (mg/dL)
  • Females: Calculated Creatinine Clearance (ml/min) = [140 - Age (yrs)] x weight (kg) / 85 x serum creatinine (mg/dL)
  • Both male or female patients were eligible. Twelve patients ≥ 70 years old and twelve patients ≤ 50 years
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  • Patients were required to have a smoking history of more than ten pack-years, where a pack-year was 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 were required to be able to inhale medication from the HandiHaler®
  • Patients were required to sign an Informed Consent Form prior to participation in the trial, including any necessary prior to pre-study washout of their usual pulmonary medications

Who cannot join

  • Patients with significant diseases other than COPD were excluded from participation in the trial. A significant disease was defined as a disease which in the opinion of the investigator may either have put the patient at risk because of participation in the trial or a disease which may have influenced the results of the trial or the patient's ability to participate in the trial;
  • Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defined a disease listed as an exclusion criterion;
  • Patients with alanine transaminase (ALT/SGOT) > 80 IU/L or aspartate transaminase (AST/SGPT) > 80 IU/L, or bilirubin > 2.0 mg/dL or creatinine > 2.0 mg/dL were excluded from participation in the trial, regardless of the patient's clinical condition. Repeat laboratory evaluations were not conducted in these patients;
  • Patients with a recent history (i.e., one year or less) of myocardial infarction (MI);
  • Patients with a recent history (i.e., three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy;
  • 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. However, patients with treated basal cell carcinoma are allowed to participate;
  • 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 a thoracotomy for other reasons were evaluated as per exclusion criterion # 1;
  • Patients who had developed an upper respiratory tract infection in six weeks prior to the Screening Visit (Visit 1) 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 treated with cromolyn sodium or nedocromil sodium;
  • Patients treated with antihistamines (H1 receptor antagonists);
  • 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 (i.e. oral contraceptives, intrauterine devices, diaphragm or Norplant®);
  • Patients with a history of asthma, allergic rhinitis or atopy or patients with a total blood eosinophil count ≥ 600/mm3. A repeat eosinophil count was not conducted in these patients;
  • Patients with history and/or active alcohol or drug abuse.
  • Patients who had taken an investigational drug within one month or six half lives (whichever was greater) prior to Screening Visit (Visit 1).

About this study

Official title: The Pharmacokinetics, Safety and Tolerability of Tiotropium in Elderly COPD Patients (Open Label, Monocenter Study).

Study to evaluate the pharmacokinetics of tiotropium following 14 days of administration (18µg once per day) in elderly COPD patients.

Being tested
Tiotropium inhalation capsules for oral inhalation
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 capsules for oral inhalationDrug

    Powder inhalation via HandiHaler®

Study groups in NCT02172326
Study groupRoleWhat they receive
Tiotropium inhalation capsulesExperimentalNot described
Receives: Drug: Tiotropium inhalation capsules for oral inhalation

What is being measured

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

  1. Total area under the plasma drug concentration-time curve (AUC 0-4 h)

    Measured: pre-dose and 5, 20 min., 1, 2,and 4 hours after dosing on days 1, 7 and 14

  2. Urinary excretion of tiotropium (Ae(0-4 hours))

    Measured: screening and on days 1, 7, 14, 15, 16, 20, 24, 28, 31, 35, 38

  3. Renal clearance of tiotropium (CLren)

    Measured: screening and on days 1, 7, 14, 15, 16, 20, 24, 28, 31, 35, 38

  4. Terminal elimination half-life after the last dose

    Measured: pre dose and 5, 20 min., 1, 2,and 4 hours after dosing on days 1, 7 and 14

Secondary outcomes (13)

  1. Plasma concentration of drug 5 min after inhalation (C5min)

    Measured: pre dose and 5, 20 min., 1, 2,and 4 hours after dosing on days 1, 7 and 14

  2. tmax (time of occurrence for maximum drug concentration)

    Measured: pre dose and 5, 20 min., 1, 2,and 4 hours after dosing on days 1, 7 and 14

  3. Change from baseline in FEV1 (Forced expiratory volume in one second)

    Measured: Baseline, Days 1, 7 and 14

  4. Change from baseline in FVC (Forced vital capacity)

    Measured: Baseline, Days 1, 7 and 14

  5. FEV1/FVC

    Measured: Baseline, Days 1, 7 and 14

  6. Symptom evaluation

    Measured: 2 weeks

  7. Use of salbutamol

    Measured: 2 weeks

  8. Occurrence of Adverse Events

    Measured: up to day 39

  9. Occurrence of Adverse Events

    Measured: up to day 38

  10. Changes form baseline in vital signs (pulse rate and blood pressure)

    Measured: up to day 38

  11. Changes from baseline in laboratory tests (haematology, clinical chemistry and urinalysis)

    Measured: baseline, day 38

  12. Changes from baseline in physical examination

    Measured: baseline, day 38

  13. Changes from baseline in ECG (Electrocardiogram)

    Measured: baseline, day 1, 7, 14 and 38

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 startFeb 1998
  3. Primary completionSep 1998

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
29 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT02172326
Sponsor's protocol ID
205.133
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 Tiotropium inhalation capsules for oral inhalation 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 10 inclusion and 21 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?

Total area under the plasma drug concentration-time curve (AUC 0-4 h) (time frame: pre-dose and 5, 20 min., 1, 2,and 4 hours after dosing on days 1, 7 and 14). The study lists 4 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 NCT02172326.

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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