Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT04780984
Tiotropium Bromide Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing Tiotropium bromide inhalation solution in people with Chronic Obstructive Pulmonary Disease (COPD), run by Nephron Pharmaceuticals Corporation at 1 site in United States.
Trial summary
A Phase 2, Randomized, Partially-blinded, Parallel Group, Dose-ranging Study to Assess the Pharmacodynamics, Relative Bioavailability, and Safety of Three Doses of Tiotropium Bromide Inhalation Solution in Subjects with Chronic Obstructive Pulmonary Disease Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Tiotropium bromide inhalation solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 26 Apr 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and nonpregnant females, ages 40 to 80 years old, inclusive.
- On a stable COPD medication regimen defined as: no new medications for or changes to medications (dose/frequency) used to manage COPD within 60 days of screening.
- Willing and able to give informed consent and follow all study procedures and requirements.
- Body mass index <35.
- Female subjects of child-bearing potential1 who are non-lactating, are using and agree tocontinue using an acceptable method of contraception for at least 4 weeks prior to first dose of study drug and until 12 weeks after last dose, and have a negative serum pregnancy test during screening. Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example: abstinence from penile-vaginal intercourse; oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; male partner sterilization at least 6 months prior to the female subject's screening visit, and this male is the sole partner for that subject (the information on the male partner's sterility can come from the site personnel's review of the subject's medical records or interview with the subject on her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).
- Female subjects of childbearing potential who agree not to donate an ova during the study and for at least 30 days after the last dose of study drug.
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- If male, agrees to use a condom with spermicide (note: no restrictions are required for a vasectomized male provided that his vasectomy was ≥ 4 months prior to the Screening Visit).
- Diagnosis of COPD, as defined by American Thoracic Society Global Initiative for Chronic Obstructive Lung Disease criteria
- Post-bronchodilator FEV1 ≥30% and ≤79%
- Post-bronchodilator FEV1/FVC ratio ≤70%
- Current or former smoker with a history of ≥ 10 pack-year history
Who cannot join
- Any condition that, in the opinion of the investigator, would interfere with the subject'sability to complete the study, would interfere with the interpretation of safety or efficacy, or would present an undue risk to the subject. In cases of uncertainty, the investigator may contact the medical monitor for clarification.
- Known respiratory disorders other than COPD that, in the opinion of the investigator, may present an unacceptable safety risk to a subject's study participation or could confound the interpretation of the study safety or efficacy results. Examples include, but are not limited to: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
- Currently taking a non-selective beta blocker. Subjects who have been on a stable dose of a cardioselective beta blocker for at least 3 months prior to screening are not excluded (examples of cardioselective beta blockers are: metoprolol, atenolol, bisoprolol, and nebivolol). Topical beta blockers for ophthalmologic conditions are permitted.
- Uncontrolled diabetes defined as HbA1c > 8.0%.
- Renal impairment defined as estimated glomerular filtration rate <50 ml/min/1.73 m2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation.
- Liver disease as defined as one or more of the following:
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- AST or ALT > 2 times the upper limit of normal (ULN).
- Total bilirubin > 2 times the ULN (subjects with bilirubin elevation patterns consistent with Gilbert's disease are permitted).
- A history of or suspected, in the opinion of the investigator, bleeding disorder. Subjectson therapeutic anticoagulation are not excluded if the investigator believes they are appropriately anticoagulated.
- Eosinophil count >600/mm3.
- History of a malignancy of any organ system (other than localized squamous or basal cell carcinoma of the skin) treated or untreated within the last 2 years prior to screening.
- Evidence or history of a clinically significant disease or abnormality, which, in the opinion of the investigator, would present and unacceptable safety risk to a subject's study participation or could confound the interpretation of the study efficacy or safety results. Examples of these conditions include, but are not limited to: NYHA Class II or higher congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, thyrotoxicosis, stroke, or cardiac dysrhythmia.
- Conditions which, in the opinion of the investigator, may contraindicate the use of an anticholinergic agent. Examples of these conditions may include, but are not limited to: paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, chronic constipation, or altered gastrointestinal motility.
- History of myasthenia gravis.
- Use of oral corticosteroids or oral antibiotics within 6 weeks prior to the Screening Visit.
- Subjects who have a positive test result on the screening urine drug screen for banned substances, including tetrahydrocannabinol or controlled substance(s) for which the subject does not have a valid prescription. Subjects taking cannabidiol should also be excluded.
- 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 known hypersensitivity to any of the proposed ingredients or components of the delivery system.
- Hospitalization for COPD or pneumonia within 8 weeks of study enrollment.
- Treatment for COPD exacerbation (defined as change in COPD symptoms requiring antibiotics and/or corticosteroids) within 12 weeks prior to enrollment.
- Have participated in pulmonary rehabilitation within 90 days of screening or are planning to participate in pulmonary rehabilitation during the course of the study
- History of 3 or more COPD exacerbations within 12 months prior to enrollment.
- Inability to refrain from COPD medications as prohibited by study protocol.
- Requires any supplemental oxygen therapy (including nocturnal oxygen).
- Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 6 weeks prior to enrollment.
- Abnormal and clinically significant electrocardiogram (ECG) findings, as determined by the investigator, at screening or during treatment.
- Lung volume reduction surgery within 12 months prior to the initiation of the study.
- Have an oxygen saturation <91% on room air at screening measured by pulse oximetry.
- Have participated in an investigational drug study within 30 days prior to screening. In addition, it is necessary that at least 5 half-lives of the previously administered investigational drug have elapsed by Visit 1.
- Subjects currently infected with COVID-19 or subjects who have previously been infected and have residual symptoms that, in the opinion of the investigator, would present a safety risk to study participation or could potentially interfere with the interpretation of safety or efficacy data in the current study. COVID-19 infection is defined as laboratory evidence of COVID-19 infection or by a constellation of signs/symptoms that, in the opinion of the investigator, are/were consistent with COVID-19 infection. Note: COVID-19 vaccination is not exclusionary.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Research of Rock Hill
Rock Hill, South Carolina, 29732
About this study
Official title: A Phase 2, Randomized, Partially-blinded, Parallel Group, Dose-ranging Study to Assess the Pharmacodynamics, Relative Bioavailability, and Safety of of Tiotropium Bromide Inhalation Solution in Subjects With COPD
A Phase 2, Randomized, Partially-blinded, Parallel Group, Dose-ranging Study to Assess the Pharmacodynamics, Relative Bioavailability, and Safety of Three Doses of Tiotropium Bromide Inhalation Solution in Subjects with Chronic Obstructive Pulmonary Disease
Read the detailed description
Objectives:
Primary:
- To determine the effect of once daily dosing with tiotropium bromide inhalation solution for 22 consecutive days on trough forced expiratory volume in 1 second (FEV1) change from baseline compared with that of placebo inhalation solution in subjects with chronic obstructive pulmonary disease (COPD).
Secondary:
- To determine the effect of once daily dosing with tiotropium bromide inhalation solution for 22 consecutive days on trough FEV1 change from baseline compared with that of Spiriva Respimat; area under the curve (AUC) FEV10-6 change from baseline compared with that of placebo and Spiriva Respimat; and trough forced vital capacity (FVC) change from baseline compared with that of placebo and Spiriva Respimat
- To assess the safety and tolerability of tiotropium bromide inhalation solution in subjects with COPD
- To assess the relative bioavailability of tiotrop
- Being tested
- Tiotropium bromide inhalation solution, 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.
Tiotropium bromide inhalation solutionDrug
Tiotropium bromide inhalation solution
PlaceboDrug
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, 2mL Receives: Drug: Placebo |
| Group 1 Tiotropium Bromide Inhalation Solution | Experimental | Treatment Dose (µg) Volume (mL) Concentration (µg/mL)
8 µg, 2.0 mL, 4 µg/mL Receives: Drug: Tiotropium bromide inhalation solution |
| Group 2 Tiotropium Bromide Inhalation Solution | Experimental | Treatment Dose (µg) Volume (mL) Concentration (µg/mL)
16 µg, 2.0 mL, 8 µg/mL Receives: Drug: Tiotropium bromide inhalation solution |
| Group 3 Tiotropium Bromide Inhalation Solution | Experimental | Treatment Dose (µg) Volume (mL) Concentration (µg/mL)
24 µg, 2.0 mL, 12 µg/mL Receives: Drug: Tiotropium bromide inhalation solution |
| Spiriva Respimat | Active comparator | 5 ug, 2 actuations, 2.5 µg/actuation Receives: Drug: Tiotropium bromide inhalation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in trough forced expiratory volume in 1 second (FEV1) compared with placebo
The primary outcome measure will be the change in trough FEV1 from baseline at Visit 4 in the 8 μg, 16 μg, and 24 μg doses of tiotropium bromide inhalation solution treatment groups compared with that of placebo, will be evaluated by using a mixed model for repeated measure (MMRM) in the mITT population.
Measured: 22 days
Secondary outcomes (2)
Change in trough FEV1 compared with placebo and Sprivia Respimat
The secondary outcome measure will be the change in trough FEV1 from baseline at Visit 2 and Visit 3 compared with that of placebo and from baseline at Visit 4 compared with that of Sprivia Respimat
Measured: 22 days
Change in forced vital capacity (FVC) compared with placebo and Sprivia Respimat
The secondary outcome measure will be the change in trough forced vital capacity (FVC) from baseline at Visit 2 and Visit 3 compared with that of placebo and from baseline at Visit 4 compared with that of Sprivia Respimat
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Nov 2020
- Primary completion20 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nephron Pharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rho, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780984
- Sponsor's protocol ID
- Neph-0002
- Status last verified
- May 2021
- First submitted
- 2 Nov 2020
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Partially-blinded, Parallel Group, Dose-ranging Study to Assess the Pharmacodynamics, Relative Bioavailability, and Safety of of Tiotropium Bromide Inhalation Solution in Subjects With COPD
- ClinicalTrials.gov ID
- NCT04780984
- Acronym / sponsor ID
- Neph-0002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Nephron Pharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Rho, Inc.
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 4 Mar 2021 (actual)
- 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.
A Phase 2, Randomized, Partially-blinded, Parallel Group, Dose-ranging Study to Assess the Pharmacodynamics, Relative Bioavailability, and Safety of Three Doses of Tiotropium Bromide Inhalation Solution in Subjects with Chronic Obstructive Pulmonary Disease
Detailed description
Objectives:
Primary:
- To determine the effect of once daily dosing with tiotropium bromide inhalation solution for 22 consecutive days on trough forced expiratory volume in 1 second (FEV1) change from baseline compared with that of placebo inhalation solution in subjects with chronic obstructive pulmonary disease (COPD).
Secondary:
- To determine the effect of once daily dosing with tiotropium bromide inhalation solution for 22 consecutive days on trough FEV1 change from baseline compared with that of Spiriva Respimat; area under the curve (AUC) FEV10-6 change from baseline compared with that of placebo and Spiriva Respimat; and trough forced vital capacity (FVC) change from baseline compared with that of placebo and Spiriva Respimat
- To assess the safety and tolerability of tiotropium bromide inhalation solution in subjects with COPD
- To assess the relative bioavailability of tiotrop
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, 2mL |
| Group 1 Tiotropium Bromide Inhalation Solution | Experimental | Drug: Tiotropium bromide inhalation solutionTreatment Dose (µg) Volume (mL) Concentration (µg/mL) 8 µg, 2.0 mL, 4 µg/mL |
| Group 2 Tiotropium Bromide Inhalation Solution | Experimental | Drug: Tiotropium bromide inhalation solutionTreatment Dose (µg) Volume (mL) Concentration (µg/mL) 16 µg, 2.0 mL, 8 µg/mL |
| Group 3 Tiotropium Bromide Inhalation Solution | Experimental | Drug: Tiotropium bromide inhalation solutionTreatment Dose (µg) Volume (mL) Concentration (µg/mL) 24 µg, 2.0 mL, 12 µg/mL |
| Spiriva Respimat | Active comparator | Drug: Tiotropium bromide inhalation solution5 ug, 2 actuations, 2.5 µg/actuation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and nonpregnant females, ages 40 to 80 years old, inclusive.
- On a stable COPD medication regimen defined as: no new medications for or changes to medications (dose/frequency) used to manage COPD within 60 days of screening.
- Willing and able to give informed consent and follow all study procedures and requirements.
- Body mass index <35.
- Female subjects of child-bearing potential1 who are non-lactating, are using and agree tocontinue using an acceptable method of contraception for at least 4 weeks prior to first dose of study drug and until 12 weeks after last dose, and have a negative serum pregnancy test during screening. Adequate contraception is defined as a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label, for example: abstinence from penile-vaginal intercourse; oral contraceptives, either combined or progestogen alone; injectable progestogen; implants of etonogestrel or levonorgestrel; estrogenic vaginal ring; percutaneous contraceptive patches; intrauterine device or intrauterine system; male partner sterilization at least 6 months prior to the female subject's screening visit, and this male is the sole partner for that subject (the information on the male partner's sterility can come from the site personnel's review of the subject's medical records or interview with the subject on her medical history); male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository); male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).
Key exclusion criteria (29 listed)
- Any condition that, in the opinion of the investigator, would interfere with the subject'sability to complete the study, would interfere with the interpretation of safety or efficacy, or would present an undue risk to the subject. In cases of uncertainty, the investigator may contact the medical monitor for clarification.
- Known respiratory disorders other than COPD that, in the opinion of the investigator, may present an unacceptable safety risk to a subject's study participation or could confound the interpretation of the study safety or efficacy results. Examples include, but are not limited to: alpha-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, or interstitial lung disease.
- Currently taking a non-selective beta blocker. Subjects who have been on a stable dose of a cardioselective beta blocker for at least 3 months prior to screening are not excluded (examples of cardioselective beta blockers are: metoprolol, atenolol, bisoprolol, and nebivolol). Topical beta blockers for ophthalmologic conditions are permitted.
- Uncontrolled diabetes defined as HbA1c > 8.0%.
- Renal impairment defined as estimated glomerular filtration rate <50 ml/min/1.73 m2 as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation.
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 bromide inhalation solutionTiotropium bromide inhalation solution | Drug | Group 1 Tiotropium Bromide Inhalation Solution, Group 2 Tiotropium Bromide Inhalation Solution, Group 3 Tiotropium Bromide Inhalation Solution, Spiriva Respimat |
| PlaceboPlacebo comparator | Drug | Placebo |
Primary outcome
Change in trough forced expiratory volume in 1 second (FEV1) compared with placebo
Time frame: 22 days
The primary outcome measure will be the change in trough FEV1 from baseline at Visit 4 in the 8 μg, 16 μg, and 24 μg doses of tiotropium bromide inhalation solution treatment groups compared with that of placebo, will be evaluated by using a mixed model for repeated measure (MMRM) in the mITT population.
2 secondary outcomes
Change in trough FEV1 compared with placebo and Sprivia Respimat
Time frame: 22 days
Change in forced vital capacity (FVC) compared with placebo and Sprivia Respimat
Time frame: 22 days
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 10 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiotropium bromide inhalation solution in people with Chronic Obstructive Pulmonary Disease (COPD), run by Nephron Pharmaceuticals Corporation at 1 site in United States.
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 11 inclusion and 29 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 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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?
Change in trough forced expiratory volume in 1 second (FEV1) compared with placebo (time frame: 22 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2021.