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COPDPhase 3ARBORUSNCT05986591

Bioequivalence Study of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 3 study testing Test Product - Tiotropium Bromide Inhalation Powder 18 mcg and Spiriva Handihaler (Tiotropium Bromide) 18 mcg in people with COPD, run by Xiromed LLC at 33 sites in 2 countries.

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

Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
COPD
What is being tested?
Test Product - Tiotropium Bromide Inhalation Powder 18 mcg and Spiriva Handihaler (Tiotropium Bromide) 18 mcg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
335 participants
Where
33 sitesin 2 countries
Study dates
17 Aug 2022to 14 Aug 2023
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

  • Patients who have signed informed consent form before initiation of any study related procedure.
  • Male or non-pregnant female patients between 40 to 75 years of age at Screening Visit.
  • General good health (except the COPD diagnosis) and free of any concomitant conditions or treatment that could interfere with study conduct.
  • An established physician diagnosis of COPD (GOLD 2022).
  • Post-bronchodilator FEV1≤80% and ≥40% of predicted normal values (GLI-2012), and post-bronchodilator FEV1/FVC ratio ≤0.70.
  • Predose FEV1 values at Visits 4 and 5 within ± 20% of the Visit 3 FEV1.
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  • Able to replace their current short-acting bronchodilators with study-provided albuterol/salbutamol inhalation aerosol provided at the Screening Visit (Visit 1) for use as needed for the duration of the study.
  • Patients must be able to discontinue their COPD maintenance medications during the run-in and treatment periods.
  • Patients must be able to withhold their short-acting β2-agonists for at least 6 hours prior to spirometry on each clinic visit at the discretion of the investigator.
  • Current or ex-smokers with ≥10 pack-year smoking history (Note: Pack-Year= (cigarettes smoked per day x years smoked)/20)).
  • Not pregnant , breastfeeding, not a woman of childbearing potential (WOCBP) or WOCBP using an acceptable contraceptive
  • No occurrence of an upper or lower respiratory tract infection during the run-in period.
  • No COPD exacerbation, defined as any worsening of COPD requiring an emergency department visit or hospitalization, or requiring excessive use of the albuterol/salbutamol rescue medication during the run-in and/or treatment period at the discretion of the Investigator, or the use of antibiotics and/or corticosteroids during the run-in period and/or treatment period.

Who cannot join

  • Treatment for COPD exacerbation within 12 weeks prior to the Screening Visit or 2 or more exacerbations in the last year.
  • Hospitalization for COPD or pneumonia within 12 weeks prior to the Screening Visit.
  • History of a life-threatening COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest, hypoxic seizures, or mMRC (Modified Medical Research Council) dyspnea Grade 4.
  • Acute upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 8 weeks prior to the Screening Visit.
  • Use of immediate-release (Oral or IV) corticosteroids within the last 30 days and/or extended-release corticosteroids (Depot or Local) within the last 12 weeks prior to the Screening Visit
  • Patients with a history of asthma or a clinical diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above 600/mm3.
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  • Patients with an abnormal/clinically significant 12-lead electrocardiogram (ECG) prior to and during screening visit, during the run-in and treatment periods.
  • Patients with myocardial infarction or unstable angina in the last 12 months; unstable or life-threatening cardiac arrhythmia requiring intervention in the last 12 months; or New York Heart Association Class II-IV heart failure.
  • Patients with documented pulmonary hypertension or clinical signs of right heart failure (indicated by an increase in jugular venous pressure with or without peripheral edema) or patients who require chronic oxygen use for >12 hours per day.
  • Presence of glaucoma or a history/family history of glaucoma.
  • History of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder-neck obstruction, or any other condition, which, in the opinion of the Investigator, would contraindicate the use of an anticholinergic agent.
  • Presence or history of urinary retention.
  • Historical or current evidence of a clinically significant disease (Note: Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the patient at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study) including, but not limited to:
  • Cardiovascular (e.g., congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, stroke, or non-controlled arrhythmias),
  • Hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, and Cushing's syndrome),
  • Gastrointestinal (e.g., poorly-controlled peptic ulcer disease),
  • Pulmonary disease other than COPD (e.g., alpha-1 antitrypsin deficiency, active bronchiectasis, cystic fibrosis, broncho-pulmonary dysplasia, sarcoidosis, lung fibrosis, pulmonary edema, interstitial lung disease, lung or mediastinum proliferative process including malignancies).
  • Patients who have undergone thoracotomy with pulmonary resection, have plans to undergo lung transplantation or lung volume reduction therapy, or have had lung volume reduction surgery within 12 months prior to the Screening Visit.
  • Have any of the following conditions that, in the judgment of the Investigator, might cause participation in this study to be detrimental to the patient, including but not limited to:
  • Current malignancy excluding basal cell carcinoma. (Note: History of malignancy is acceptable only if the patient has been in remission for one year prior to the Screening Visit. Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 5 years prior to the Screening Visit.
  • Current or untreated tuberculosis (Note: History of tuberculosis is acceptable only if a patient has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years).
  • Uncontrolled hypertension (systolic blood pressure [BP] ≥160 or diastolic BP >100).
  • Stroke within 12 months prior to the Screening Visit
  • Immunocompromised
  • History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or specific intolerance to aerosolized tiotropium-containing products or its derivatives (e.g., ipratropium, oxitropium), or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
  • History of alcohol or drug abuse within 2 years prior to the Screening Visit (Visit 1).

Trial locations and contacts

33 sites in 2 countries.

33 sites in 2 countries

United States24 sites

  • Velocity Clinical Research Anderson

    Anderson, South Carolina, 29621

  • Velocity Clinical Research-Cincinnati

    Cincinnati, Ohio, 45242

  • Velocity Clinical Research Columbia

    Columbia, South Carolina, 29204

  • Greater Providence Clinical Research (East North)

    Cranston, Rhode Island, 02920

  • Inquest Clinical Research

    Cypress, Texas, 77433

  • Southwest General Heathcare

    Fort Myers, Florida, 33907

  • Velocity Clinical Research Gaffney

    Gaffney, South Carolina, 29340

  • SIMED Health

    Gainesville, Florida, 32607

  • Velocity Clinical Research Grants Pass (W Coast)

    Grants Pass, Oregon, 97527

  • Velocity Clinical Research Greenville

    Greenville, South Carolina, 29615

  • Mt. Olympus Medical Research

    Houston, Texas, 77479

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • Clinical Research Solutions

    Kissimmee, Florida, 34744

  • DownTown LA Research (West Coast)

    Los Angeles, California, 90017

  • Velocity Clinical Research Medford

    Medford, Oregon, 97504

  • Clintex Research Group, Inc.

    Miami, Florida, 33145

  • Research Institue of South Florida

    Miami, Florida, 33173

  • Vista Health Research

    Miami, Florida, 33176

  • Velocity Clinical Research - New Smyrna Beach

    New Smyrna Beach, Florida, 32132

  • Velocity Clinical Research Spartanburg

    Spartanburg, South Carolina, 29303

  • Velocity clinical Research Syracuse (East North))

    Syracuse, New York, 13057

  • Velocity Clinical Research Union

    Union, South Carolina, 29379

  • Velocity Clinical Research-Utah

    West Jordan, Utah, 84088

  • Southern Clinical Research

    Zachary, Louisiana, 70791

Other trials in United States

India9 sites

  • Anand Surgical Hospital Pvt. Ltd

    Ahmedabad

  • Care and Cure Multispeciality Hospital

    Ahmedabad

  • Hope Medicare Centre

    Ahmedabad

  • Divine Multispeciality Hopsital

    Gandhinagar

  • Maharaja Agrasen Superspeciality Hospital

    Jaipur

  • Shree Hospital & Critical Care Centre

    Nagpur

  • Chest Disease Hospital

    Srinagar

  • Global Hospital

    Surat

  • Dhawal Multispeciality Hospital

    Vadodara

Other trials in India

About this study

Official title: A Multicenter, Randomized, Placebo-Controlled, Crossover, Single Dose Study To Demonstrate Clinical Pharmacodynamic Bioequivalence of Tiotropium 18 μg Inhalation Powder, Hard Capsule With Spiriva®Handihaler® 18 μg Inhalation Powder, Hard Capsule in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Bioequivalence Study of Tiotropium Bromide Inhalation Powder 18 μg

Read the detailed description

Pharmacodynamic bioequivalence study after a single dose of Tiotropium Bromide Inhalation Powder 18 μg vs Spiriva Handihaler (Tiotropium Bromide) 18 mcg

Conditions
COPD
Being tested
Test Product - Tiotropium Bromide Inhalation Powder 18 mcg, Spiriva Handihaler (Tiotropium Bromide) 18 mcg, Placebo
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.

  • Test Product - Tiotropium Bromide Inhalation Powder 18 mcgCombination product

    Test Product

  • Spiriva Handihaler (Tiotropium Bromide) 18 mcgCombination product

    RLD

  • PlaceboCombination product

    Placebo Product

Study groups in NCT05986591
Study groupRoleWhat they receive
Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder)ExperimentalNot described
Receives: Combination Product: Test Product - Tiotropium Bromide Inhalation Powder 18 mcg
Treatment B: 18 mcg of Reference Product (Spiriva)Active comparatorNot described
Receives: Combination Product: Spiriva Handihaler (Tiotropium Bromide) 18 mcg
PlaceboPlacebo comparatorNot described
Receives: Combination Product: Placebo

What is being measured

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

  1. Primary PD parameter - Adjusted area under the serial spirometry FEV1-time curve

    Baseline-adjusted area under the serial spirometry FEV1-time curve calculated from time 0 to 24 hours (AUC0-24h) following treatment

    Measured: 24 Hours

Timeline

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

  1. First posted14 Aug 2023
  2. Study start17 Aug 2022
  3. Primary completion11 Aug 2023
  4. Study completion14 Aug 2023

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
Randomised
Intervention model
Crossover
Model description
Randomized, placebo-controlled, single dose, three-way crossover design.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
335 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05986591
Sponsor's protocol ID
2019-TIOT-0200-PD-01
Acronym
ARBORUS
Status last verified
Jan 2024
First submitted
3 Aug 2023
Last updated
31 Jan 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Test Product - Tiotropium Bromide Inhalation Powder 18 mcg and Spiriva Handihaler (Tiotropium Bromide) 18 mcg in people with COPD, run by Xiromed LLC at 33 sites in 2 countries.

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 26 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 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Primary PD parameter - Adjusted area under the serial spirometry FEV1-time curve (time frame: 24 Hours). 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 NCT05986591.

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 Jan 2024.

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