Pulmonary Disease, Chronic ObstructivePhase 2NCT02242266

Pharmacokinetics and Safety Comparison of Tiotropium Inhalation Powder Administered as the Bromide Salt From Hard Polyethylene Capsule Via the HandiHaler® 2 and Spiriva® HandiHaler® in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing Tiotropium low dose, Tiotropium medium dose and Spiriva® HandiHaler® high dose 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

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium low dose, Tiotropium medium dose and Spiriva® HandiHaler® high dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: No sites listed yet
Study dates: 28 Jul 2005to 4 Jun 2006
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions
All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a pre-dose FEV1 <= 60% of predicted normal and FEV1 <= 70% of FVC at Visits 1 and 2.
* The randomization of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period should be postponed. Patients may be randomized 6 weeks following recovery from the infection or exacerbation
At Visit 1, patients must demonstrate an improvement in FEV1 of >= 12% over the baseline FEV1 value 45 minutes after inhalation of 4 puffs of 20 µg ipratropium bromide (Atrovent® MDI)
Male or female patients 40 years of age or older

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Patients must be current or ex-smokers with a smoking history of more than 10 pack-years (Patients who had never smoked cigarettes had to be excluded)
Patients must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol
Patients must be able to inhale medication in a competent manner from the HandiHaler® 2 and the HandiHaler® devices

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 a recent history (i.e., six months or less) of myocardial infarction
Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year
Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed
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 patients

Show all 23Show fewer

Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
Patients with known active tuberculosis
Patients with significant alcohol or drug abuse within the past two years
Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1
Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study
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 being treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions. See exclusion criterion No 6
Patients who are being treated with cromolyn sodium or nedocromil sodium
Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system (Spiriva® HandiHaler®; tiotropium HandiHaler 2)
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous three months (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants, e.g.: Norplant®)
Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Visit 1
Patients who have been treated with oral beta-adrenergics within one month prior to Visit 1 or during the run-in period
Patients who have been treated with theophylline preparations within one month prior to Visit 1 or during the run-in period
Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within one month prior to Visit 1 or during the run-in period
Patients with any respiratory infections in the six weeks prior to the Screening Visit (Visit 1) or during the run-in period. In the case of a respiratory infection during the run-in period the latter may be extended up to six weeks
Patients who are currently participating in another study23. The randomisation of patients with any respiratory infection or COPD exacerbation in the six weeks prior to the Screening Visit (Visit 1) or during the baseline period should be postponed. Patients may be randomised six weeks following recovery from the infection or exacerbation

About this study

Official title: A Single Dose, Placebo-controlled, Randomized, Double-blind, Double-dummy, Crossover Efficacy, Pharmacokinetics and Safety Comparison of Tiotropium Inhalation Powder (5 μg and 10 μg), Administered as the Bromide Salt From Hard Polyethylene Capsule Via the HandiHaler® 2 and Spiriva® HandiHaler® (18 μg Tiotropium) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of this trial was to establish non-inferiority of lung function response to tiotropium 10 μg, formulated as inhalation powder in the polyethylene hard capsule and delivered via the HandiHaler® 2, compared to tiotropium 18 μg, formulated as inhalation powder in the hard gelatine capsule and delivered via the HandiHaler® (Spiriva®) following single dose inhalation in patients with COPD. A hard polyethylene (PE) capsule with half the strength (tiotropium 5 μg) was included to investigate a dose ordering effect.

The secondary objectives were to characterize the pharmacokinetics of tiotropium inhalation powder hard PE capsule (delivered via HandiHaler® 2) and tiotropium inhalation powder hard gelatine capsule (delivered via HandiHaler®) and to compare the safety of the two pharmaceutical formulations.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium low dose, Tiotropium medium dose, Spiriva® HandiHaler® high dose, Placebo via the blue HandiHaler®, Placebo via the grey HandiHaler®
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 low doseDrug
inhalation powder, hard PE capsule
Tiotropium medium doseDrug
inhalation powder, hard PE capsule
Spiriva® HandiHaler® high doseDrug
Tiotropium inhalation powder, hard gelatine capsule
Placebo via the blue HandiHaler®Drug
oral inhalation via the blue HandiHaler®
Placebo via the grey HandiHaler®Drug
oral inhalation via the grey HandiHaler®

Study groups in NCT02242266
Study group	Role	What they receive
Tiotropium low dose	Experimental	oral inhalation via the blue HandiHaler® Receives: Drug: Tiotropium low dose; Drug: Placebo via the grey HandiHaler®
Tiotropium medium dose	Experimental	oral inhalation via the blue HandiHaler® Receives: Drug: Tiotropium medium dose; Drug: Placebo via the grey HandiHaler®
Spiriva® HandiHaler® high dose	Active comparator	oral inhalation via the grey HandiHaler® Receives: Drug: Spiriva® HandiHaler® high dose; Drug: Placebo via the blue HandiHaler®
Placebo	Placebo comparator	Not described Receives: Drug: Placebo via the blue HandiHaler®; Drug: Placebo via the grey HandiHaler®

What is being measured

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

Area under the curve for the time period 0 to 12 hours of forced expiratory volume in one second (FEV1 AUC0-12)
Measured: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing

Secondary outcomes (17)

Peak FEV1 on each test-day
Peak FEV1 is defined as the maximum FEV1 obtained within the first three hours post dosing
Measured: pre-dose and 30, 60 minutes, 2 and 3 hours post-dosing
Peak forced vital capacity (FVC)
Measured: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
FVC AUC0-12
Measured: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
FEV1 AUC12-24
Measured: 12, 14, 22, 23 and 24 hours post-dosing
FEV1 AUC0-24
Measured: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
FVC AUC12-24
Measured: 12, 14, 22, 23 and 24 hours post-dosing
FVC AUC0-24
Measured: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Individual FEV1 measurements at each time point
Measured: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Individual FVC measurements at each time point
Measured: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)
Measured: 5, 15, 30 minutes, 1 and 2 hours following drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Measured: 5, 15, 30 minutes, 1 and 2 hours following drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: 5, 15, 30 minutes, 1 and 2 hours following drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Measured: 0 to 2, 2 to 12 hours after administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: 0 to 2, 2 to 12 hours after administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: 0 to 2, 2 to 12 hours after administration
%AUCtz-∞ (percentage of the extrapolated part of the total AUC0-∞)
Measured: 5, 15, 30 minutes, 1 and 2 hours following drug administration
Number of patients with adverse events
Measured: up to 13 weeks

Timeline

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

28 Jul 20054 Jun 2006

First posted17 Sep 2014 (estimated)
Study start28 Jul 2005
Primary completion4 Jun 2006

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02242266
Sponsor's protocol ID: 1184.9
Status last verified: Nov 2023
First submitted: 16 Sep 2014
Last updated: 1 Dec 2023
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 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose, Placebo-controlled, Randomized, Double-blind, Double-dummy, Crossover Efficacy, Pharmacokinetics and Safety Comparison of Tiotropium Inhalation Powder (5 μg and 10 μg), Administered as the Bromide Salt From Hard Polyethylene Capsule Via the HandiHaler® 2 and Spiriva® HandiHaler® (18 μg Tiotropium) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT02242266
Acronym / sponsor ID: 1184.9
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 28 Jul 2005 (actual)
Primary completion: 4 Jun 2006 (actual)
First posted: 17 Sep 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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
Tiotropium low dose	Experimental	Drug: Tiotropium low dose, Drug: Placebo via the grey HandiHaler®oral inhalation via the blue HandiHaler®
Tiotropium medium dose	Experimental	Drug: Tiotropium medium dose, Drug: Placebo via the grey HandiHaler®oral inhalation via the blue HandiHaler®
Spiriva® HandiHaler® high dose	Active comparator	Drug: Spiriva® HandiHaler® high dose, Drug: Placebo via the blue HandiHaler®oral inhalation via the grey HandiHaler®
Placebo	Placebo comparator	Drug: Placebo via the blue HandiHaler®, Drug: Placebo via the grey HandiHaler®

Who may qualify

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

Key inclusion criteria (9 listed)

All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions
All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a pre-dose FEV1 <= 60% of predicted normal and FEV1 <= 70% of FVC at Visits 1 and 2.
At Visit 1, patients must demonstrate an improvement in FEV1 of >= 12% over the baseline FEV1 value 45 minutes after inhalation of 4 puffs of 20 µg ipratropium bromide (Atrovent® MDI)
Male or female patients 40 years of age or older

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 a recent history (i.e., six months or less) of myocardial infarction
Patients who have been hospitalized for heart failure (NYHA class III or IV) within the past year
Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed

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 low doseinhalation powder, hard PE capsule	Drug	Tiotropium low dose
Tiotropium medium doseinhalation powder, hard PE capsule	Drug	Tiotropium medium dose
Spiriva® HandiHaler® high doseTiotropium inhalation powder, hard gelatine capsule	Drug	Spiriva® HandiHaler® high dose
Placebo via the blue HandiHaler®oral inhalation via the blue HandiHaler®	Drug	Placebo, Spiriva® HandiHaler® high dose
Placebo via the grey HandiHaler®oral inhalation via the grey HandiHaler®	Drug	Placebo, Tiotropium low dose, Tiotropium medium dose

Primary outcome

Area under the curve for the time period 0 to 12 hours of forced expiratory volume in one second (FEV1 AUC0-12)
Time frame: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing

17 secondary outcomes

Peak FEV1 on each test-day
Time frame: pre-dose and 30, 60 minutes, 2 and 3 hours post-dosing
Peak forced vital capacity (FVC)
Time frame: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
FVC AUC0-12
Time frame: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing
FEV1 AUC12-24
Time frame: 12, 14, 22, 23 and 24 hours post-dosing
FEV1 AUC0-24
Time frame: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
FVC AUC12-24
Time frame: 12, 14, 22, 23 and 24 hours post-dosing
FVC AUC0-24
Time frame: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Individual FEV1 measurements at each time point
Time frame: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Individual FVC measurements at each time point
Time frame: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: 5, 15, 30 minutes, 1 and 2 hours following drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: 5, 15, 30 minutes, 1 and 2 hours following drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: 5, 15, 30 minutes, 1 and 2 hours following drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2)
Time frame: 0 to 2, 2 to 12 hours after administration
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: 0 to 2, 2 to 12 hours after administration
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: 0 to 2, 2 to 12 hours after administration
%AUCtz-∞ (percentage of the extrapolated part of the total AUC0-∞)
Time frame: 5, 15, 30 minutes, 1 and 2 hours following drug administration
Number of patients with adverse events
Time frame: up to 13 weeks

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 1 Dec 2023.

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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 2 study testing Tiotropium low dose, Tiotropium medium dose and Spiriva® HandiHaler® high dose 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 9 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 1 Dec 2023. 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 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?

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 for the time period 0 to 12 hours of forced expiratory volume in one second (FEV1 AUC0-12) (time frame: pre-dose and 30, 60 minutes, 2, 3, 4, 6, 8, 10 and 12 hours post-dosing). 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 NCT02242266.

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 1 Dec 2023.