Clinical trial NCT06254664: Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule,Zephir Inhaler Device
Official title: Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Zephir Inhaler Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Lead sponsor: Xiromed LLC
Sponsor class: INDUSTRY
Collaborators: name: Laboratorios Liconsa
First posted: 2024-02-12
Enrollment: 116
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule, Inhaler Device. Zephir inhaler robustness will be assessed by in vitro testing of the Zephir inhaler after 12 weeks of patient use


Eligibility criteria: Inclusion Criteria (abbreviated):

1. Capable of understanding the requirements, risks, and benefits of study participation, and as judged by the Investigator, capable of giving written informed consent.
2. Male or non-pregnant female subjects between 40 to 75 years of age at Screening Visit (Visit 1) diagnosed with COPD.
3. General good health (except the COPD diagnosis) and free of any concomitant conditions that would put the subject at increased risk during the study as per the discretion of the Investigator.
4. An established physician diagnosis of COPD as defined by GOLD 2022.
5. At Screening Visit, post-bronchodilator FEV1≤80% and ≥40% of predicted normal values as per Global Lung Function Initiative (GLI-2012) - and post-bronchodilator FEV1/FVC ratio ≤0.70.
6. Current COPD Therapy: Subjects must be on stable regimens of one of the following for at least 8 weeks prior to screening (Visit 1):

   * Long-acting muscarinic antagonist (LAMA)
   * LAMA+LABA
   * Inhaled corticosteroids + LAMA
7. Current or ex-smokers with ≥10 pack-year smoking history (Note: Pack- Year= (cigarettes smoked per day x years smoked)/20)).
8. No occurrence of an upper or lower respiratory tract infection 14 days before Screening Visit.
9. No COPD exacerbation, defined as any worsening of COPD requiring an emergency department visit or hospitalization, or the use of antibiotics (strong CYP450 3A4 inhibitors with ≥ 14 days of acute non-respiratory
10. Ability to adequately use the Test inhaler.

Exclusion Criteria (Abbreviated):

1. Treatment for mild-moderate COPD exacerbations within 4 weeks prior to the Screening Visit (Visit 1) or more exacerbations in the last year.
2. Hospitalization for COPD or pneumonia within 12 weeks prior to the Screening Visit (Visit 1).
3. 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.
4. Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 4 weeks prior to the Screening Visit (Visit 1).
5. Subjects with a history of asthma or a clinical diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above 600/mm3.
6. Historical or current evidence of a clinically significant disease
7. Have any of the following conditions that, in the judgment of the Investigator, might cause participation in this study to be detrimental to the subject.
8. A subject must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the Investigator, would put the safety of the subject at risk through study participation.
9. 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.

Primary outcomes:
measure: In vitro Measurement of Emitted Dose
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Vanguard Clinical Research, LLC
state: Florida
city: Kissimmee
country: United States
facility: Clinical Research Solutions - Orlando
state: Florida
city: Miami
country: United States
facility: Clintex Research Group
state: Florida
city: Miami
country: United States
facility: My Preferred Research LLC
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida, Inc.
state: Florida
city: Miami
country: United States
facility: Vista Health Research
state: Florida
city: Cranston
country: United States
facility: Greater Providence Clinical Research, LLC
state: Rhode Island
city: Cypress
country: United States
facility: Inquest Clinical Research, LL
state: Texas
city: Ahmedabad
country: India
facility: Cliantha Research
state: Gujarat
Study officials:
References: