COPDPhase 3NCT05161156
Bioequivalence Study of Tiotropium Bromide Inhalation Powder
A Phase 3 study testing Test Product (tiotropium bromide inhalation powder) and 18 mcg of Spiriva (Reference Product) in people with COPD, run by Phargentis SA at 17 sites in 3 countries.
Trial summary
This study is to characterize the pharmacodynamic characteristics and to assess the therapeutic bioequivalence after single dose of Tiotropium Bromide Inhalation Powder-test relative to Tiotropium Bromide Inhalation Powder-reference in Adult Patients with Chronic Obstructive Pulmonary Disease (COPD) as primary… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Test Product (tiotropium bromide inhalation powder) and 18 mcg of Spiriva (Reference Product)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 24 Mar 2022to 29 Nov 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must sign an ICF and is willing to participate in the study
- Male or female participant must be of ≥ 40 years of age
- Be medically stable on the basis of physical examination, medical history, and vital signs, chest X-ray and 12-lead ECG performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and recorded
- Be medically stable on the basis of clinical laboratory tests performed at screening as defined.
- Participants with documented Diagnosis of COPD, as defined by American Thoracic Society (ATS) [GOLD criteria] at screening.
- Pre-bronchodilator FEV1 ≥ 35% and ≤ 80% of predicted at screening and visits 3-5 as defined.
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- Demonstrate at screening, post-bronchodilator FEV1≤80% of predicted.
- Must demonstrate at screening, post-bronchodilator FEV1/FVC ratio ≤0.70
- Demonstrate ≥ 15 % reversibility of FEV1 within 45 minutes following 4 inhalations of bronchodilator inhalation aerosol (84 mcg).
- Must administer at least 70% doses of placebo during the run-in period.
- Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years at Screening (visit 1)
- Not pregnant , breastfeeding, not a woman of childbearing potential (WOCBP) or WOCBP using an acceptable contraceptive
- Participants willing and able to adhere to the protocol lifestyle restrictions
- Participants able to understand and comply with the study procedures.
Who cannot join
- Participants with history of liver or defined renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- Known respiratory disorder other than COPD, including but not limited to the following: active tuberculosis, lung cancer, alpha-1-antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema or interstitial lung disease
- Participants with α1-antitrypsin deficiency as the underlying cause of COPD at screening.
- Participants with history of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hypertrophy, or bladder neck obstruction, which would contraindicate the use of an anticholinergic agent.
- Participants with history of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agent, beta-2 adrenergic agonists, lactose/milk proteins or specific intolerance to aerosolized tiotropium or ipratropium bromide-containing products or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
- Participants with abnormal and clinically significant electrocardiogram (ECG) finding prior to the study screening and randomization as per investigator discretion.
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- Participants with use of oral/parenteral corticosteroids or antibiotics for COPD within 6 weeks or depot corticosteroids within 3 months prior to screening.
- Participants with hospitalization for COPD or pneumonia within 12 weeks prior to study screening and randomization.
- Participants with treatment for COPD exacerbation within 12 weeks prior to study screening and randomization.
- Participants with acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 6 weeks prior to screening.
- Patients with sign and/or symptoms suggestive of COVID 19 infection at the time of screening.
- Participants with lung volume reduction surgery within the previous 12 months of randomization.
- Participants with chronic oxygen uses for >12 hours/day.
- Participants with evidence or history of other clinically significant disease or abnormal (such as congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, stroke, glaucoma or cardiac dysrhythmia) condition for which participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
- Participants had major surgery, (e.g., requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time of the study.
- Participants with history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- Participants with history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening.
- Participant is unable to stop the medications at the defined times prior to screening
- Participants with history of drug or alcohol abuse within 1 years before screening or positive test result(s) for alcohol or drugs of abuse at Screening.
- Intended use of over the counter or prescription medication including herbal medications within 14 days prior to dosing.
- Participants received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days or 5 half-lives prior to baseline, whichever is longer, or is currently enrolled in an investigational study.
- Participants who are medically unable to withhold participant's salbutamol for the at least 4-hour period required prior to spirometry testing at each study visit.
- Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 2 weeks after the last dose of study intervention.
- Plans to father a child while enrolled in this study or within 2 weeks after the last dose of study intervention.
- Participants that experiences a moderate or a severe COPD exacerbation or pneumonia during the run-in period will be excluded.
- Participants requires nocturnal oxygen or continuous supplemental oxygen therapy.
- Participant that requires a change in COPD medication from rescue medication or participants required rescue medications more than acceptable frequency during the screening or run-in period will be excluded.
- Employee of the investigator or study site
- Participants unable to perform maneuver (correct inhalation technique) according to study requirement despite device training
- Participants unable to perform acceptable or repeatable spirometry or comply with other study procedures
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
India13 sites
Investigational Site 119
Ahmedabad, Gujarat, 380006
Investigational Site 101
Ahmedabad, Gujarat, 382345
Investigational Site 120
Gandhinagar, Gujarat, 382421
Investigational Site 118
Jammu, Jammu and Kashmir, 190001
Investigational Site 106
Nagpur, Maharashtra, 440009
Investigational Site 105
Nagpur, Maharashtra, 440015
Investigational Site 121
Nashik, Maharashtra, 422002
Investigational Site 112
Nashik, Maharashtra, 422101
Investigational Site 111
Pune, Maharashtra, 411038
Investigational Site 108
Sābarmatī, Gujarat, 380005
Investigational Site 114
Surat, Gujarat, 395006
Investigational Site 102
Vadodara, Gujarat, 390012
Investigational Site 107
Vadodara, Gujarat, 390022
United States3 sites
Investigational Site 203
Anderson, South Carolina, 29621
Investigational Site 204
Gaffney, South Carolina, 29340
Investigational Site 205
Union, South Carolina, 29379
About this study
Official title: Multicentre,Randomized,Double-Blind,Double-Dummy,3period,6Seq,Crossover,Active&Placebo,SD PD Study to Evaluate Therapeutic Equivalence of Test Tiotropium Bromide Inh. Powder to Reference SPIRIVA® HANDIHALER in Subjects w/COPD*
This study is to characterize the pharmacodynamic characteristics and to assess the therapeutic bioequivalence after single dose of Tiotropium Bromide Inhalation Powder-test relative to Tiotropium Bromide Inhalation Powder-reference in Adult Patients with Chronic Obstructive Pulmonary Disease (COPD) as primary objective
Read the detailed description
Pharmadynamic study conducted in accordance requirements and recommendations per the US FDA's 2017 product specific "Draft Guidance on Tiotropium Bromide"
- Conditions
- COPD
- Being tested
- Test Product (tiotropium bromide inhalation powder), 18 mcg of Spiriva (Reference Product), 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)Combination product
A single dose of test product
18 mcg of Spiriva (Reference Product)Combination product
Also called RLD, SPIRIVA HandiHaler
A single dose of reference product (Spiriva)
PlaceboCombination product
A single dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder) | Experimental | 2 inhalations of test product, followed by 2 inhalations of reference placebo product Receives: Combination Product: Test Product (tiotropium bromide inhalation powder); Combination Product: Placebo |
| Treatment B: 18 mcg of Reference Product (Spiriva) | Active comparator | 2 inhalations of reference product, followed by 2 inhalations of test placebo product Receives: Combination Product: 18 mcg of Spiriva (Reference Product); Combination Product: Placebo |
| Treatment C: Zero-dose (Placebo) | Placebo comparator | 2 inhalations of reference placebo powder, followed by 2 inhalations of test placebo product Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted17 Dec 2021
- Study start24 Mar 2022
- Primary completion29 Nov 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, double-dummy, placebo controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phargentis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161156
- Sponsor's protocol ID
- C2A01096
- Status last verified
- Apr 2023
- First submitted
- 2 Dec 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre,Randomized,Double-Blind,Double-Dummy,3period,6Seq,Crossover,Active&Placebo,SD PD Study to Evaluate Therapeutic Equivalence of Test Tiotropium Bromide Inh. Powder to Reference SPIRIVA® HANDIHALER in Subjects w/COPD*
- ClinicalTrials.gov ID
- NCT05161156
- Acronym / sponsor ID
- C2A01096
- Conditions
- COPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Phargentis SAIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 17 Dec 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.
This study is to characterize the pharmacodynamic characteristics and to assess the therapeutic bioequivalence after single dose of Tiotropium Bromide Inhalation Powder-test relative to Tiotropium Bromide Inhalation Powder-reference in Adult Patients with Chronic Obstructive Pulmonary Disease (COPD) as primary objective
Detailed description
Pharmadynamic study conducted in accordance requirements and recommendations per the US FDA's 2017 product specific "Draft Guidance on Tiotropium Bromide"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double-blind, double-dummy, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder) | Experimental | Combination Product: Test Product (tiotropium bromide inhalation powder), Combination Product: Placebo2 inhalations of test product, followed by 2 inhalations of reference placebo product |
| Treatment B: 18 mcg of Reference Product (Spiriva) | Active comparator | Combination Product: 18 mcg of Spiriva (Reference Product), Combination Product: Placebo2 inhalations of reference product, followed by 2 inhalations of test placebo product |
| Treatment C: Zero-dose (Placebo) | Placebo comparator | Combination Product: Placebo2 inhalations of reference placebo powder, followed by 2 inhalations of test placebo product |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participant must sign an ICF and is willing to participate in the study
- Male or female participant must be of ≥ 40 years of age
- Be medically stable on the basis of physical examination, medical history, and vital signs, chest X-ray and 12-lead ECG performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and recorded
- Be medically stable on the basis of clinical laboratory tests performed at screening as defined.
- Participants with documented Diagnosis of COPD, as defined by American Thoracic Society (ATS) [GOLD criteria] at screening.
Key exclusion criteria (30 listed)
- Participants with history of liver or defined renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- Known respiratory disorder other than COPD, including but not limited to the following: active tuberculosis, lung cancer, alpha-1-antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema or interstitial lung disease
- Participants with α1-antitrypsin deficiency as the underlying cause of COPD at screening.
- Participants with history of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hypertrophy, or bladder neck obstruction, which would contraindicate the use of an anticholinergic agent.
- Participants with history of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agent, beta-2 adrenergic agonists, lactose/milk proteins or specific intolerance to aerosolized tiotropium or ipratropium bromide-containing products or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
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 |
|---|---|---|
| Test Product (tiotropium bromide inhalation powder)A single dose of test product | Combination product | Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder) |
| 18 mcg of Spiriva (Reference Product)Also: RLD, SPIRIVA HandiHalerA single dose of reference product (Spiriva) | Combination product | Treatment B: 18 mcg of Reference Product (Spiriva) |
| PlaceboA single dose of placebo | Combination product | Treatment A: 18 mcg of Test Product (tiotropium bromide inhalation powder), Treatment B: 18 mcg of Reference Product (Spiriva), Treatment C: Zero-dose (Placebo) |
Primary outcome
Primary PD parameter - Adjusted area under the serial spirometry FEV1-time curve
Time frame: 24 hours
Baseline-adjusted area under the serial spirometry FEV1-time curve calculated from time 0 to 24 hours (AUC0-24h) following treatment
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 Apr 2023.
- Individual participant dataSharing planned: No
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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.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Test Product (tiotropium bromide inhalation powder) and 18 mcg of Spiriva (Reference Product) in people with COPD, run by Phargentis SA at 17 sites in 3 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 14 inclusion and 30 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in India, United States, Switzerland. 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?
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 Apr 2023.