Pulmonary Disease, Chronic ObstructivePhase 3NCT01559116
Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease
A Phase 3 study testing tiotropium + olodaterol, tiotropium and olodaterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 29 sites in 7 countries.
Trial summary
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- tiotropium + olodaterol, tiotropium and olodaterol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 29 sitesin 7 countries
- Study dates
- Mar 2012to Aug 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of chronic obstructive pulmonary disease
- Relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal and a post-bronchodilator FEV1/FVC <70%
- Male or female patients, 40 years of age or older
- Smoking history of more than 10 pack years
- Ability to perform technically acceptable pulmonary function tests and maintain records
- Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI)
Who cannot join
- significant disease other than COPD
- clinically relevant abnormal lab values
- history of asthma
- diagnosis of thyrotoxicosis
- diagnosis of paroxysmal tachycardia
- history of myocardial infarction
Show all 25Show fewer
- unstable or life-threatening cardiac arrhythmia
- Hospitalization for heart failure within the past year
- known active tuberculosis
- malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- history of life-threatening pulmonary obstruction
- history of cystic fibrosis
- clinically evident bronchiectasis
- history of significant alcohol or drug abuse
- history of thoracotomy with pulmonary resection
- oral or patch ß-adrenergics
- oral corticosteroid medication at unstable doses
- regular use daytime oxygen therapy for more than one hour per day
- Pulmonary rehabilitation program in the six weeks prior to the screening visit
- Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
- Pregnant or nursing women
- Women of childbearing potential not using a highly effective method of birth control
- Patients who have previously been randomised in this study or are currently participating in another study
- Patients who are unable to comply with pulmonary medication restrictions prior to randomisation
Trial locations and contacts
29 sites in 7 countries.
29 sites in 7 countries
Germany7 sites
1237.20.49205 Boehringer Ingelheim Investigational Site
Berlin
1237.20.49204 Boehringer Ingelheim Investigational Site
Großhansdorf
1237.20.49203 Boehringer Ingelheim Investigational Site
Hamburg
1237.20.49206 Boehringer Ingelheim Investigational Site
Hamburg
1237.20.49201 Boehringer Ingelheim Investigational Site
Mannheim
1237.20.49207 Boehringer Ingelheim Investigational Site
Mönchengladbach
1237.20.49202 Boehringer Ingelheim Investigational Site
Wiesbaden
Hungary5 sites
1237.20.36202 Boehringer Ingelheim Investigational Site
Gödöllö
1237.20.36204 Boehringer Ingelheim Investigational Site
Komárom
1237.20.36203 Boehringer Ingelheim Investigational Site
Pécs
1237.20.36201 Boehringer Ingelheim Investigational Site
Szarvas
1237.20.36205 Boehringer Ingelheim Investigational Site
Százhalombatta
Netherlands5 sites
1237.20.31205 Boehringer Ingelheim Investigational Site
Almelo
1237.20.31202 Boehringer Ingelheim Investigational Site
Breda
1237.20.31201 Boehringer Ingelheim Investigational Site
Heerlen
1237.20.31204 Boehringer Ingelheim Investigational Site
Hengelo
1237.20.31203 Boehringer Ingelheim Investigational Site
Zutphen
United States4 sites
1237.20.1203 Boehringer Ingelheim Investigational Site
Easley, South Carolina
1237.20.1201 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1237.20.1204 Boehringer Ingelheim Investigational Site
Jasper, Alabama
1237.20.1202 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
Belgium3 sites
1237.20.32203 Boehringer Ingelheim Investigational Site
Genk
1237.20.32201 Boehringer Ingelheim Investigational Site
Ghent
1237.20.32204 Boehringer Ingelheim Investigational Site
Jambes
Denmark3 sites
1237.20.45002 Boehringer Ingelheim Investigational Site
Hvidovre
1237.20.45003 Boehringer Ingelheim Investigational Site
Odense C
1237.20.45001 Boehringer Ingelheim Investigational Site
Silkeborg
Canada2 sites
1237.20.02202 Boehringer Ingelheim Investigational Site
Québec, Quebec
1237.20.02201 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
About this study
Official title: Randomised, Double-blind, Placebo-controlled, 6 Treatment, 4 Period, Incomplete Cross-over Trial to Characterise the 24-hour Lung Function Profiles of Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg, 5/5 µg), Tiotropium (2.5 µg, 5 µg) and Olodaterol (5 µg) (Oral Inhalation, Delivered by the Respimat® Inhaler) After 6 Weeks Once Daily Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM]
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tiotropium + olodaterol, tiotropium, olodaterol, Placebo, Respimat
- 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 + olodaterolDrug
low dose + one dose only
tiotropiumDrug
low dose
olodaterolDrug
one dose only
tiotropiumDrug
high dose
tiotropium + olodaterolDrug
low dose + one dose only
PlaceboDrug
placebo matching tiotropium+olodaterol FDC
RespimatDevice
Respimat inhaler
| Study group | Role | What they receive |
|---|---|---|
| tiotropium+olodaterol FDC low dose | Experimental | tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing) Receives: Drug: tiotropium + olodaterol; Device: Respimat |
| tiotropium+olodaterol FDC high dose | Experimental | tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing) Receives: Drug: tiotropium + olodaterol; Device: Respimat |
| tiotropium low dose | Active comparator | tiotropium low dose; 2 inhalations once daily (a.m. dosing) Receives: Drug: tiotropium; Device: Respimat |
| tiotropium high dose | Active comparator | tiotropium high dose; 2 inhalations once daily (a.m. dosing) Receives: Drug: tiotropium; Device: Respimat |
| olodaterol | Active comparator | one dose only; 2 inhalations once daily (a.m. dosing) Receives: Drug: olodaterol; Device: Respimat |
| placebo | Placebo comparator | 2 inhalations once daily (a.m. dosing) Receives: Drug: Placebo; Device: Respimat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Measured: day 1 and week 6
Secondary outcomes (9)
FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 12 h post-dose, using the trapezoidal rule, divided by the duration (12h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Measured: day 1 and week 6
FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Measured: day 1 and week 6
Trough FEV1 Response [L] After 6 Weeks Treatment.
Trough Forced Expiratory Volume in 1 second (FEV1) response after 6 weeks treatment period.
The trough was defined as the mean of the 23 h and 23 h50 min measurements and Response was defined as the change from patient baseline.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Measured: day 1 and week 6
Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.
Peak (0-3h) Forced Expiratory Volume in 1 second (FEV1) response.
The peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Measured: day 1 and week 6
FVC AUC0-24h Response [L] After 6 Weeks Treatment.
Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 24 h post-dose using the trapezoidal rule, divided by the duration (24 h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Measured: day 1 and week 6
FVC AUC0-12h Response [L] After 6 Weeks Treatment.
Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 0 to 12 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Measured: day 1 and week 6
FVC AUC12-24h Response [L] After 6 Weeks Treatment.
Area under the Forced Vital Capacity (FVC) after 6 weeks treatment period-time curve from 12 to 24 h post-dose using the trapezoidal rule, divided by the duration (12 h) to report in litres.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Measured: day 1 and week 6
Trough FVC Response [L] After 6 Weeks Treatment.
Trough Forced Vital Capacity (FVC) response after 6 weeks treatment period.
The trough was defined as the mean of the 23 h and 23 h50 min measurements and response was defined as the change from patient baseline.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Measured: day1 and week 6
Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.
Peak (0-3h) Forced Vital Capacity (FVC) responses after 6 weeks treatment.
Peak was defined as the maximum value measured within the first 3 h post dosing and response was defined as the change from patient baseline.
Mean is actually the Adjusted mean.
The adjusted mean (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
Measured: day 1 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559116
- Sponsor's protocol ID
- 1237.20
- Other IDs
- 2011-004710-42
- Status last verified
- Jun 2015
- First submitted
- 19 Mar 2012
- Last updated
- 16 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Beeh KM, Westerman J, Kirsten AM, Hebert J, Gronke L, Hamilton A, Tetzlaff K, Derom E. The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2015 Jun;32:53-9. doi: 10.1016/j.pupt.2015.04.002. Epub 2015 May 6.
PubMed 25956072
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled, 6 Treatment, 4 Period, Incomplete Cross-over Trial to Characterise the 24-hour Lung Function Profiles of Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg, 5/5 µg), Tiotropium (2.5 µg, 5 µg) and Olodaterol (5 µg) (Oral Inhalation, Delivered by the Respimat® Inhaler) After 6 Weeks Once Daily Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM]
- ClinicalTrials.gov ID
- NCT01559116
- Acronym / sponsor ID
- 1237.20
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Posted 16 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| tiotropium+olodaterol FDC low dose | Experimental | Drug: tiotropium + olodaterol, Device: Respimattiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing) |
| tiotropium+olodaterol FDC high dose | Experimental | Drug: tiotropium + olodaterol, Device: Respimattiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing) |
| tiotropium low dose | Active comparator | Drug: tiotropium, Device: Respimattiotropium low dose; 2 inhalations once daily (a.m. dosing) |
| tiotropium high dose | Active comparator | Drug: tiotropium, Device: Respimattiotropium high dose; 2 inhalations once daily (a.m. dosing) |
| olodaterol | Active comparator | Drug: olodaterol, Device: Respimatone dose only; 2 inhalations once daily (a.m. dosing) |
| placebo | Placebo comparator | Drug: Placebo, Device: Respimat2 inhalations once daily (a.m. dosing) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of chronic obstructive pulmonary disease
- Relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal and a post-bronchodilator FEV1/FVC <70%
- Male or female patients, 40 years of age or older
- Smoking history of more than 10 pack years
- Ability to perform technically acceptable pulmonary function tests and maintain records
Key exclusion criteria (25 listed)
- significant disease other than COPD
- clinically relevant abnormal lab values
- history of asthma
- diagnosis of thyrotoxicosis
- diagnosis of paroxysmal tachycardia
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 + olodaterollow dose + one dose only | Drug | tiotropium+olodaterol FDC high dose |
| tiotropiumlow dose | Drug | tiotropium low dose |
| olodaterolone dose only | Drug | olodaterol |
| tiotropiumhigh dose | Drug | tiotropium high dose |
| tiotropium + olodaterollow dose + one dose only | Drug | tiotropium+olodaterol FDC low dose |
| Placeboplacebo matching tiotropium+olodaterol FDC | Drug | placebo |
| RespimatRespimat inhaler | Device | olodaterol, placebo, tiotropium high dose, tiotropium low dose, tiotropium+olodaterol FDC high dose, tiotropium+olodaterol FDC low dose |
Primary outcome
Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.
Time frame: day 1 and week 6
Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.
9 secondary outcomes
FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.
Time frame: day 1 and week 6
FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.
Time frame: day 1 and week 6
Trough FEV1 Response [L] After 6 Weeks Treatment.
Time frame: day 1 and week 6
Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.
Time frame: day 1 and week 6
FVC AUC0-24h Response [L] After 6 Weeks Treatment.
Time frame: day 1 and week 6
FVC AUC0-12h Response [L] After 6 Weeks Treatment.
Time frame: day 1 and week 6
FVC AUC12-24h Response [L] After 6 Weeks Treatment.
Time frame: day 1 and week 6
Trough FVC Response [L] After 6 Weeks Treatment.
Time frame: day1 and week 6
Peak (0-3h) FVC Response [L] After 6 Weeks Treatment.
Time frame: day 1 and week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25956072Beeh KM, Westerman J, Kirsten AM, Hebert J, Gronke L, Hamilton A, Tetzlaff K, Derom E. The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2015 Jun;32:53-9. doi: 10.1016/j.pupt.2015.04.002. Epub 2015 May 6.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
29 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tiotropium + olodaterol, tiotropium and olodaterol in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 29 sites in 7 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 6 inclusion and 25 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 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, Hungary, Netherlands, United States, Belgium and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 16 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment. (time frame: day 1 and week 6). 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 NCT01559116, 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 Jul 2015.