AsthmaPhase 2NCT01634113
Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo in 1 to 5 Year Old Patients With Persistent Asthma
A Phase 2 study testing tiotropium-bromide in people with Asthma, run by Boehringer Ingelheim at 33 sites in 11 countries.
Trial summary
The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Asthma
- What is being tested?
- tiotropium-bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 33 sitesin 11 countries
- Study dates
- Jul 2012to Dec 2014
- Phase
- Phase 2
- 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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients' parents (or legal guardians) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial. Where appropriate, participants should assent to enroll in the study.
- Male or female patients between 1 and 5 years of age.
- By a physician documented (at least 6 month) history of persistent asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath. (persistent = need for inhalation corticosteroid maintenance therapy to control asthma symptoms)
- For patients aged 5 years and capable of performing technically acceptable Pulmonary Function tests (PFTs): documented impaired lung function (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is smaller or equal to 90% of predicted normal).
- All patients must have been on maintenance treatment with an inhaled corticosteroid at stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1.
- All patients must be symptomatic (partly controlled) as defined by the Global Initiative for Asthma (GINA) guideline for children aged 5 years and younger in the week prior to Visit 1 (screening) and in the week prior to randomisation (Visit 2).
- Further inclusion criteria apply.
Who cannot join
- Patients with a significant disease other than asthma.
- Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1.
- Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year.
- Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation) or a change in drug therapy within the past year.
- Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy.
- Patients with clinically significant lung diseases other than asthma.
Show all 11Show fewer
- Alternative causes (other causes than asthma) that can lead to respiratory symptoms of wheeze, cough and shortness of breath.
- Patients with known active tuberculosis.
- Patients who have undergone thoracotomy with pulmonary resection.
- Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the 6 weeks prior to the screening visit (Visit 1).
- Further exclusion criteria apply.
Trial locations and contacts
33 sites in 11 countries.
33 sites in 11 countries
Ukraine5 sites
205.443.07003 Boehringer Ingelheim Investigational Site
Dnipropetrovsk
205.443.07002 Boehringer Ingelheim Investigational Site
Donetsk
205.443.07005 Boehringer Ingelheim Investigational Site
Vinnytsia
205.443.07004 Boehringer Ingelheim Investigational Site
Zaporizhya
205.443.07001 Boehringer Ingelheim Investigational Site
Zaporizhzhya
United States4 sites
205.443.12006 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
205.443.12003 Boehringer Ingelheim Investigational Site
Columbia, Missouri
205.443.12005 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
205.443.12004 Boehringer Ingelheim Investigational Site
Summerville, South Carolina
Germany4 sites
205.443.03003 Boehringer Ingelheim Investigational Site
Berlin
205.443.03001 Boehringer Ingelheim Investigational Site
Bochum
205.443.03002 Boehringer Ingelheim Investigational Site
Ettenheim
205.443.03010 Boehringer Ingelheim Investigational Site
Frankfurt
Belgium3 sites
205.443.01004 Boehringer Ingelheim Investigational Site
Antwerp
205.443.01002 Boehringer Ingelheim Investigational Site
Brussels
205.443.01001 Boehringer Ingelheim Investigational Site
Edegem
Latvia3 sites
205.443.05001 Boehringer Ingelheim Investigational Site
Balvi
205.443.05003 Boehringer Ingelheim Investigational Site
Rēzekne
205.443.05002 Boehringer Ingelheim Investigational Site
Riga
Malaysia3 sites
205.443.10002 Boehringer Ingelheim Investigational Site
Kelantan
205.443.10001 Boehringer Ingelheim Investigational Site
Kuala Lumpur
205.443.10003 Boehringer Ingelheim Investigational Site
Kuala Pahang
South Korea3 sites
205.443.82003 Boehringer Ingelheim Investigational Site
Guri-si
205.443.82002 Boehringer Ingelheim Investigational Site
Incheon
205.443.82001 Boehringer Ingelheim Investigational Site
Seoul
Finland2 sites
205.443.02002 Boehringer Ingelheim Investigational Site
Helsinki
205.443.02003 Boehringer Ingelheim Investigational Site
Turku
Lithuania2 sites
205.443.06002 Boehringer Ingelheim Investigational Site
Vilnius
205.443.06003 Boehringer Ingelheim Investigational Site
Vilnius
Netherlands2 sites
205.443.04003 Boehringer Ingelheim Investigational Site
Breda
205.443.04001 Boehringer Ingelheim Investigational Site
Groningen
Philippines2 sites
205.443.09001 Boehringer Ingelheim Investigational Site
Quezon City
205.443.09002 Boehringer Ingelheim Investigational Site
Quezon City
About this study
Official title: A Phase II/III, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution (2.5 µg and 5 µg) Administered Once Daily in the Afternoon Via Respimat® Inhaler for 12 Weeks in Patients 1 to 5 Years Old With Persistent Asthma
The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.
- Conditions
- Asthma
- Being tested
- tiotropium-bromide, placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiotropium-bromideDrug
IMP
tiotropium-bromideDrug
IMP
placeboDrug
placebo matching tiotropium
| Study group | Role | What they receive |
|---|---|---|
| tiotropium low dose | Experimental | Once daily, delivered with Respimat® inhaler Receives: Drug: tiotropium-bromide |
| tiotropium high dose | Experimental | Once daily, delivered with Respimat® inhaler Receives: Drug: tiotropium-bromide |
| placebo | Placebo comparator | Once daily, delivered with Respimat® inhaler Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Mean Combined Daytime Asthma Symptom Score
Change from baseline in the weekly mean combined daytime asthma symptom score as assessed by the Paediatric Asthma Caregivers Diary (PACD) in the last week of the 12 week treatment period.
The PACD is a diary designed to evaluate daily asthma symptoms in children aged 2-5 years. The diary consists of three questions to be answered each morning, when the child wakes up, and seven questions to be answered each evening, right after the child goes to bed for the night. A week was defined as 7 days.
The combined daytime score is the average of scores from questions 4 - 7 in the diary which are questions regarding severity of cough, wheezing, trouble breathing and interference with activities, scores for each question range from 0 (best) to 5 (worst). The week 12 weekly mean is the mean of the responses for each day averaged over the 7 days in week 12, so combined daytime asthma symptom scores also range from 0 (best) to 5 (worst).
The measured values presented are adjusted means.
Measured: Baseline and 12 weeks
FEV1 Peak (0-3h) Change From Baseline
Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak (0-3h)) measured at week 12
Measured: 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Secondary outcomes (11)
Weekly Mean Overnight Asthma Symptom Score Response
Change from baseline in the weekly mean overnight asthma symptom score response as assessed by the PACD in the last week of the 12 week treatment period.
The overnight score is the score from the following question in the PACD, "How much did your child cough last night after your child was put to bed for the night until he/she awoke this morning?". This endpoint was determined only for patients with 2 or more nights with symptoms per week during the baseline period. In this case, the baseline period is the 7 days used to derive the baseline value. A patient has a night with symptoms if the question was answered with scores 1, 2, 3, 4 or 5 or the patient received β-Agonist at least one time since he/she went to bed. A week was defined as 7 days.
Scores range from 0 (best) to 4 (worst), a value of 5 indicates severity of symptoms is unknown.
The measured values presented are adjusted means
Measured: Baseline and 12 weeks
Weekly Percentage of Days Without Asthma Symptoms
Weekly Percentage of days without asthma symptoms at week 12.
A day without asthma symptoms was defined as a day during which the patient experienced no asthma symptoms, did not use rescue medication (salbutamol/albuterol) and had no asthma exacerbation/worsening requiring systemic corticosteroids, or unscheduled visits to a doctor's office, emergency department, or hospital. A week was defined as 7 days.
The measured values presented are adjusted means
Measured: 12 weeks
Weekly Percentage of Days With Use of Salbutamol (Albuterol) Rescue Medication
Weekly percentage of days with use of salbutamol (albuterol) rescue medication at week 12. A week was defined as 7 days.
Measured: 12 weeks
Weekly Mean Nighttime Awakenings Due to Asthma Symptoms
Change from baseline in the weekly mean nighttime awakenings due to asthma symptoms as assessed by the PACD, in the last week of the 12 week treatment period.
The weekly mean was calculated as the average of the weekly scores for the question "Did your child wake up during the night due to his/her asthma?" The question was answered on a 5-point verbal rating scale, with scores ranging from 1 (did not wake up) to 5 (was awake all night). A week was defined as 7 days.
The measured values presented are adjusted means
Measured: Baseline and 12 weeks
Trough FEV1 Change From Baseline
Change from baseline in Trough (pre-dose) Forced expiratory volume in 1 second (FEV1) measured at week 12.
Measured: Baseline and 12 weeks
FEV1 AUC (0-3h) Change From Baseline
Change from baseline of area under the curve (AUC) from 0 to 3 h for FEV1 (FEV1 AUC 0-3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured: 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
FVC Peak (0-3h) Change From Baseline
Change from baseline in maximum forced vital capacity (FVC) measured within the first 3 hours after administration of trial medication (FVC peak (0-3h)) after 12 weeks of treatment.
Measured: 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Trough FVC Change From Baseline
Change from baseline of trough (pre-dose) forced vital capacity (FVC) measured 10 min before the administration of trial medication after 12 weeks of treatment.
Measured: Baseline and 12 weeks
FVC AUC (0-3h) Change From Baseline
Change from baseline of area under the curve (AUC) from 0 to 3 h for FVC (FVC AUC0-3h) after 12 weeks of treatment. The AUC was calculated by using the trapezoidal rule divided by the observation time (3h).
Measured: 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Individual FEV1 Measurements
Change from baseline in individual FEV1 measurements at each timepoint after 12 weeks
Measured: Baseline and 12 weeks
Individual FVC Measurements
Change from baseline in individual FVC measurements at each timepoint after 12 weeks
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01634113
- Sponsor's protocol ID
- 205.443
- Other IDs
- 2011-005512-28
- Status last verified
- Jun 2015
- First submitted
- 16 Apr 2012
- Last updated
- 23 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Wachtel H, Nagel M, Engel M, El Azzi G, Sharma A, Suggett J. In vitro and clinical characterization of the valved holding chamber AeroChamber Plus(R) Flow-Vu(R) for administrating tiotropium Respimat(R) in 1-5-year-old children with persistent asthmatic symptoms. Respir Med. 2018 Apr;137:181-190. doi: 10.1016/j.rmed.2018.03.010. Epub 2018 Mar 7.
PubMed 29605203Vrijlandt EJLE, El Azzi G, Vandewalker M, Rupp N, Harper T, Graham L, Szefler SJ, Moroni-Zentgraf P, Sharma A, Vulcu SD, Sigmund R, Chawes B, Engel M, Bisgaard H. Safety and efficacy of tiotropium in children aged 1-5 years with persistent asthmatic symptoms: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2018 Feb;6(2):127-137. doi: 10.1016/S2213-2600(18)30012-2. Epub 2018 Jan 18.
PubMed 29361462
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution (2.5 µg and 5 µg) Administered Once Daily in the Afternoon Via Respimat® Inhaler for 12 Weeks in Patients 1 to 5 Years Old With Persistent Asthma
- ClinicalTrials.gov ID
- NCT01634113
- Acronym / sponsor ID
- 205.443
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Posted 23 Jun 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 this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of inhaled corticosteroid (ICS) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tiotropium low dose | Experimental | Drug: tiotropium-bromideOnce daily, delivered with Respimat® inhaler |
| tiotropium high dose | Experimental | Drug: tiotropium-bromideOnce daily, delivered with Respimat® inhaler |
| placebo | Placebo comparator | Drug: placeboOnce daily, delivered with Respimat® inhaler |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- All patients' parents (or legal guardians) must sign and date an informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial. Where appropriate, participants should assent to enroll in the study.
- Male or female patients between 1 and 5 years of age.
- By a physician documented (at least 6 month) history of persistent asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath. (persistent = need for inhalation corticosteroid maintenance therapy to control asthma symptoms)
- For patients aged 5 years and capable of performing technically acceptable Pulmonary Function tests (PFTs): documented impaired lung function (i.e. pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is smaller or equal to 90% of predicted normal).
- All patients must have been on maintenance treatment with an inhaled corticosteroid at stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before Visit 1.
Key exclusion criteria (11 listed)
- Patients with a significant disease other than asthma.
- Patients with clinically relevant abnormal screening haematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion 1.
- Patients with a history of congenital or acquired heart disease, or patients who have been hospitalised for cardiac syncope or failure during the past year.
- Patients with any unstable or life-threatening cardiac arrhythmia, including cardiac arrhythmia requiring intervention (e.g. pacemaker implantation) or a change in drug therapy within the past year.
- Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy.
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-bromideIMP | Drug | tiotropium high dose |
| tiotropium-bromideIMP | Drug | tiotropium low dose |
| placeboplacebo matching tiotropium | Drug | placebo |
Primary outcome
Weekly Mean Combined Daytime Asthma Symptom Score
Time frame: Baseline and 12 weeks
Change from baseline in the weekly mean combined daytime asthma symptom score as assessed by the Paediatric Asthma Caregivers Diary (PACD) in the last week of the 12 week treatment period. The PACD is a diary designed to evaluate daily asthma symptoms in children aged 2-5 years. The diary consists of three questions to be answered each morning, when the child wakes up, and seven questions to be answered each evening, right after the child goes to bed for the night. A week was defined as 7 days. The combined daytime score is the average of scores from questions 4 - 7 in the diary which are questions regarding severity of cough, wheezing, trouble breathing and interference with activities, scores for each question range from 0 (best) to 5 (worst). The week 12 weekly mean is the mean of the responses for each day averaged over the 7 days in week 12, so combined daytime asthma symptom scores also range from 0 (best) to 5 (worst). The measured values presented are adjusted means.
FEV1 Peak (0-3h) Change From Baseline
Time frame: 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Change from baseline in peak Forced expiratory volume in 1 second within the first 3 hours post dosing (FEV1 peak (0-3h)) measured at week 12
11 secondary outcomes
Weekly Mean Overnight Asthma Symptom Score Response
Time frame: Baseline and 12 weeks
Weekly Percentage of Days Without Asthma Symptoms
Time frame: 12 weeks
Weekly Percentage of Days With Use of Salbutamol (Albuterol) Rescue Medication
Time frame: 12 weeks
Weekly Mean Nighttime Awakenings Due to Asthma Symptoms
Time frame: Baseline and 12 weeks
Trough FEV1 Change From Baseline
Time frame: Baseline and 12 weeks
FEV1 AUC (0-3h) Change From Baseline
Time frame: 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
FVC Peak (0-3h) Change From Baseline
Time frame: 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Trough FVC Change From Baseline
Time frame: Baseline and 12 weeks
FVC AUC (0-3h) Change From Baseline
Time frame: 10 minutes before drug administration and 30 minutes, 1 hour (h), 2h and 3h after drug administration at baseline and week 12
Individual FEV1 Measurements
Time frame: Baseline and 12 weeks
Individual FVC Measurements
Time frame: Baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29605203Wachtel H, Nagel M, Engel M, El Azzi G, Sharma A, Suggett J. In vitro and clinical characterization of the valved holding chamber AeroChamber Plus(R) Flow-Vu(R) for administrating tiotropium Respimat(R) in 1-5-year-old children with persistent asthmatic symptoms. Respir Med. 2018 Apr;137:181-190. doi: 10.1016/j.rmed.2018.03.010. Epub 2018 Mar 7.
- Derived from this study: PubMed 29361462Vrijlandt EJLE, El Azzi G, Vandewalker M, Rupp N, Harper T, Graham L, Szefler SJ, Moroni-Zentgraf P, Sharma A, Vulcu SD, Sigmund R, Chawes B, Engel M, Bisgaard H. Safety and efficacy of tiotropium in children aged 1-5 years with persistent asthmatic symptoms: a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2018 Feb;6(2):127-137. doi: 10.1016/S2213-2600(18)30012-2. Epub 2018 Jan 18.
- 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
33 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tiotropium-bromide in people with Asthma, run by Boehringer Ingelheim at 33 sites in 11 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 7 inclusion and 11 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 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Ukraine, United States, Germany, Belgium, Latvia and 6 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 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?
Yes. Results are posted in the registry (first posted 23 Jun 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?
Weekly Mean Combined Daytime Asthma Symptom Score (time frame: Baseline and 12 weeks). The study lists 2 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 NCT01634113, which also lists 2 linked publications.
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 23 Jun 2015.