Open Label Study to Assess the Effect of Patient Use and Robustness of Tiotropium 18ug Inhalation Powder, Hard Capsule,Zephir Inhaler Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2023-10-27

Brief Summary

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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

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Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tiotropium 18 µg inhalation powder, hard capsule once daily (QD)

Interventions:

Drug: Tiotropium 18 µg inhalation powder, hard capsule

Device: Zephir inhaler

Group Type EXPERIMENTAL

Tiotropium 18 µg inhalation powder, hard capsule

Intervention Type DRUG

Tiotropium 18 µg administered using Zephir inhaler

Zephir inhaler

Intervention Type DEVICE

Tiotropium 18 µg administered using Zephir inhaler

Interventions

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Tiotropium 18 µg inhalation powder, hard capsule

Tiotropium 18 µg administered using Zephir inhaler

Intervention Type DRUG

Zephir inhaler

Tiotropium 18 µg administered using Zephir inhaler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No