COPDPhase 4NCT02541006
Comparison of 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe COPD
A Phase 4 study testing Tiotropium 18 mcg in people with COPD, run by Neutec Ar-Ge San ve Tic A.Ş.
Trial summary
The objective of this study is to compare the bronchodilator efficacy a of tiotropium inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Tiotropium 18 mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Aug 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 40 years and older with moderate to severe COPD diagnosis
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
- Patients with established clinical COPD and severity defined as a post-broncodilator FEV1/FVC ratio of ≤0.70 and FEV1 ≤80 % of predicted normal at screening
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- Have no excacerbation within last 4 weeks
- Hava capability of communicate with investigator
- Accept to adapt the procedures of study protocol
- Signed and dated informed consent
Who cannot join
- History of hypersensitivity to anticholinergics
- Diagnosis of asthma
- History of alergic rinit and athopy
- Current or history of lung cancer
- Known symptomatic prostatic hypertrophy requiring drug therapy
- Known narrow-angle glaucoma requiring drug therapy
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- Have experienced exacerbation of COPD or lower respiratory inflammatory disease requiring use of antibiotics, oral or parenteral corticosteroids (CS) within 4 weeks prior to screening visit and/or during run-in period
- Patients vaccinated with poored virüs vaccinate within 2 weeks prior to screening visit and/or during run-in period
- Patients with a recent history of myocardial infarction, acute ischemic cardiac disease or severe cardiac arrhythmia requiring drug therapy
- Women who are pregnant or lactating or are planning on becoming pregnant during the study
About this study
Official title: A Randomized, Parallel-group, Phase IV Study to Compare the Bronchodilator Efficacy of Tiotropium (18 µg Once Daily [od]) Delivered Via a DISCAIR With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
The objective of this study is to compare the bronchodilator efficacy a of tiotropium inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
- Conditions
- COPD
- Being tested
- Tiotropium 18 mcg
- Keywords
- FEV1, FVC, AUC 0-24, bronchodilator efficacy, tiotropium
- 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 18 mcgDrug
tiotropium 18 mcg once a day
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium 18 mcg dry powder for inhalation | Experimental | Tiotropium 18 mcg dry powder for inhalation, one inhalation, once daily with the DISCAIR Receives: Drug: Tiotropium 18 mcg |
| SPIRIVA 18 mcg HANDIHALER | Active comparator | Tiotropium 18 mcg dry powder capsul for inhalation one capsule once daily with the HandiHaler Receives: Drug: Tiotropium 18 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
Measured: prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Percantage (%) change from baseline in FEV1 and FVC
Measured: prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours -Post-dose
Measured: Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
- Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response
Measured: Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Secondary outcomes (2)
Time to onset of bronchodilator effect and maximum effect
Measured: 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Adverse Events
Measured: predose and up to 24 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startNov 2014
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Neutec Ar-Ge San ve Tic A.S, Study director, Neutec Ar-Ge San ve Tic A.S Clinical Trial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541006
- Sponsor's protocol ID
- Neu-21.12
- Status last verified
- Nov 2013
- First submitted
- 2 Sep 2015
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yildiz P, Bayraktaroglu M, Gorgun D, Secik F. Bronchodilator efficacy of 18 mug once-daily tiotropium inhalation via Discair(R) versus HandiHaler(R) in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial. Int J Chron Obstruct Pulmon Dis. 2016 Nov 22;11:2859-2867. doi: 10.2147/COPD.S119114. eCollection 2016.
PubMed 27920513
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-group, Phase IV Study to Compare the Bronchodilator Efficacy of Tiotropium (18 µg Once Daily [od]) Delivered Via a DISCAIR With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD
- ClinicalTrials.gov ID
- NCT02541006
- Acronym / sponsor ID
- Neu-21.12
- Conditions
- COPD
- Keywords
- FEV1, FVC, AUC 0-24, bronchodilator efficacy, tiotropium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Sep 2015 (estimated)
- 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.
The objective of this study is to compare the bronchodilator efficacy a of tiotropium inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium 18 mcg dry powder for inhalation | Experimental | Drug: Tiotropium 18 mcgTiotropium 18 mcg dry powder for inhalation, one inhalation, once daily with the DISCAIR |
| SPIRIVA 18 mcg HANDIHALER | Active comparator | Drug: Tiotropium 18 mcgTiotropium 18 mcg dry powder capsul for inhalation one capsule once daily with the HandiHaler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 40 years and older with moderate to severe COPD diagnosis
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
- Patients with established clinical COPD and severity defined as a post-broncodilator FEV1/FVC ratio of ≤0.70 and FEV1 ≤80 % of predicted normal at screening
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- Have no excacerbation within last 4 weeks
Key exclusion criteria (10 listed)
- History of hypersensitivity to anticholinergics
- Diagnosis of asthma
- History of alergic rinit and athopy
- Current or history of lung cancer
- Known symptomatic prostatic hypertrophy requiring drug therapy
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 18 mcgtiotropium 18 mcg once a day | Drug | SPIRIVA 18 mcg HANDIHALER, Tiotropium 18 mcg dry powder for inhalation |
Primary outcome
Median maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC)
Time frame: prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Percantage (%) change from baseline in FEV1 and FVC
Time frame: prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Standardized Area Under the Curve (AUC) Between Baseline (Pre-dose) and 24 Hours -Post-dose
Time frame: Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
- Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 - 24h (AUC 0-24) Response
Time frame: Baseline FEV1 taken at visit 2 prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
2 secondary outcomes
Time to onset of bronchodilator effect and maximum effect
Time frame: 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose
Adverse Events
Time frame: predose and up to 24 hours postdose
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 16 Jun 2020.
- Background: PubMed 27920513Yildiz P, Bayraktaroglu M, Gorgun D, Secik F. Bronchodilator efficacy of 18 mug once-daily tiotropium inhalation via Discair(R) versus HandiHaler(R) in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial. Int J Chron Obstruct Pulmon Dis. 2016 Nov 22;11:2859-2867. doi: 10.2147/COPD.S119114. eCollection 2016.
- 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.
Neutec Ar-Ge San ve Tic A.S study director
Neutec Ar-Ge San ve Tic A.S Clinical Trial
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tiotropium 18 mcg in people with COPD, run by Neutec Ar-Ge San ve Tic A.Ş.
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 8 inclusion and 10 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 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Median maximum change (ml) from baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) (time frame: prior to the first dose of randomised study medication. Then, 15 minutes (min), 30 min,1 hour (h),2h,3h,4h,6h,8h,12 h and 24 h post dose). The study lists 4 primary outcomes in all. 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 NCT02541006, which also lists 1 linked publication.
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 16 Jun 2020.