Pulmonary Disease, Chronic ObstructivePhase 2NCT02242227
Efficacy, Pharmacokinetics and Safety Comparison of Salmeterol Inhalation Powder Administered Via the HandiHaler® 2 and Serevent® Diskus® in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Salmeterol xinafoate and Serevent® Diskus® in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
The primary objective of this trial was to establish non-inferiority of lung function response to 25 μg salmeterol, administered as the xinafoate salt, in an inhalation powder delivered from hard polyethylene (PE) capsules via the HandiHaler® 2 compared to Serevent® Diskus® (salmeterol 50 μg, administered as the… 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?
- Salmeterol xinafoate and Serevent® Diskus®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Feb 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients must have relatively stable* airway obstruction with a pre-dose FEV1 ≤ 60% of predicted normal and FEV1 ≤ 70% of FVC at Visits 1 and 2.
- *The enrolment of patients who have had an exacerbation within six weeks prior to planned study entry should be postponed
- At Visit 1, patients must demonstrate an improvement in FEV1 of ≥ 12% over the pre-bronchodilator value 45 minutes after inhalation of 4 puffs of 100 μg salbutamol (Sultanol® MDI)
- Male or female patients 40 years of age or older
Show all 9Show fewer
- Patients must be current or ex-smokers with a smoking history of more than 10 pack-years ((Patients who have never smoked cigarettes must be excluded)
- Patients must be able to perform technically acceptable pulmonary function tests during the study period as required in the protocol
- Patients must be able to inhale medication in a competent manner from the HandiHaler® 2 device and the Diskus® device
Who cannot join
- Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- Patients with a recent history (i.e., six months or less) of myocardial infarction
- Patients who have been hospitalized for heart failure (New York Heart Association (NYHA) class III or IV) within the past year
- Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
- Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed
- Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count ≥600/mm3
Show all 23Show fewer
- Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
- Patients with known active tuberculosis
- Patients with significant alcohol or drug abuse within the past two years
- Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1
- Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study
- Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy
- Patients who are being treated with antihistamines (H1 receptor antagonists), antileukotrienes or leukotriene receptor antagonists for asthma or excluded allergic conditions
- Patients who have been treated with cromolyn sodium or nedocromil sodium within one month prior to Visit 1 or during the run-in period
- Patients using oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
- Patients with known hypersensitivity to beta-adrenergics, lactose or any other components of the inhalation capsule delivery system or the Diskus®
- Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for the previous three months (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants, e.g.: Norplant®)
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Visit 1
- Patients who have been treated with oral beta-adrenergics within one month prior to Visit 1 or during the run-in period
- Patients who have been treated with theophylline preparations within one month prior to Visit 1 or during the run-in period
- Patients who have been treated with the long-acting anticholinergic tiotropium (Spiriva®) within one month prior to Visit 1 or during the run-in period
- Patients with any respiratory infections in the six weeks prior to the Screening Visit (Visit 1) or during the run-in period. In the case of a respiratory infection during the run-in period the latter may be extended up to six weeks
- Patients who are currently participating in another study
About this study
Official title: A Single Dose, Placebo-controlled, Randomized, Double-blind, Double-dummy, Crossover Efficacy, Pharmacokinetics and Safety Comparison of Salmeterol Inhalation Powder (25 μg Salmeterol), Administered as the Xinafoate Salt From a Hard Polyethylene Capsule Via the HandiHaler® 2, and Serevent® Diskus® (50 μg Salmeterol) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The primary objective of this trial was to establish non-inferiority of lung function response to 25 μg salmeterol, administered as the xinafoate salt, in an inhalation powder delivered from hard polyethylene (PE) capsules via the HandiHaler® 2 compared to Serevent® Diskus® (salmeterol 50 μg, administered as the xinafoate salt) following single dose inhalation in patients with COPD.
The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation powder delivered by HandiHaler® 2 from the PE hard capsule and salmeterol xinafoate delivered by Serevent® Diskus®, and to compare the safety of the two pharmaceutical forms.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Salmeterol xinafoate, Serevent® Diskus®, Placebo (HandiHaler®), Placebo (Diskus®)
- 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.
Salmeterol xinafoateDrug
Serevent® Diskus®Drug
Placebo (HandiHaler®)Drug
Placebo (Diskus®)Drug
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol xinafoate | Experimental | 25 μg Salmeterol inhalation powder administered via HandiHaler® Receives: Drug: Salmeterol xinafoate; Drug: Placebo (Diskus®) |
| Serevent® Diskus® | Active comparator | 50 μg Salmeterol (dry powder inhaler) administered via Diskus® Receives: Drug: Serevent® Diskus®; Drug: Placebo (HandiHaler®) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (HandiHaler®); Drug: Placebo (Diskus®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in area under the curve for the time period 0 to 12 hours (AUC0-12h) of the forced expiratory volume in one second (FEV1)
Measured: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing
Secondary outcomes (23)
Change in peak FEV1
Peak FEV1 is defined as the maximum FEV1 obtained within the first three hours post dosing
Measured: within 3 hours post-dosing
Change in FEV1 AUC12-24h
Measured: 12, 14, 22, 23 and 24 hours post-dosing
Change in FEV1 AUC0-24h
Measured: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Individual FEV1 measurements at each time point
Measured: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Change in forced vital capacity (FVC) AUC0-12h
Measured: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing
Change in peak FVC
Measured: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Change in FVC AUC12-24h
Measured: 12, 14, 22, 23 and 24 hours post-dosing
Change in FVC AUC0-24h
Measured: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Individual FVC measurements at each time point
Measured: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Number of patients with adverse events
Measured: up to 23 days
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2; a time interval from 0 - 8 h is appropriate)
Measured: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Measured: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
λz (terminal rate constant in plasma)
Measured: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
t½ (terminal half-life of the analyte in plasma)
Measured: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
MRTih (mean residence time of the analyte in the body after inhalational administration)
Measured: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time interval t1 to t2)
Measured: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
Measured: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
Measured: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startSep 2005
- Primary completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242227
- Sponsor's protocol ID
- 1184.10
- Status last verified
- Sep 2014
- First submitted
- 16 Sep 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Placebo-controlled, Randomized, Double-blind, Double-dummy, Crossover Efficacy, Pharmacokinetics and Safety Comparison of Salmeterol Inhalation Powder (25 μg Salmeterol), Administered as the Xinafoate Salt From a Hard Polyethylene Capsule Via the HandiHaler® 2, and Serevent® Diskus® (50 μg Salmeterol) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02242227
- Acronym / sponsor ID
- 1184.10
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Feb 2006 (actual)
- First posted
- 17 Sep 2014 (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 primary objective of this trial was to establish non-inferiority of lung function response to 25 μg salmeterol, administered as the xinafoate salt, in an inhalation powder delivered from hard polyethylene (PE) capsules via the HandiHaler® 2 compared to Serevent® Diskus® (salmeterol 50 μg, administered as the xinafoate salt) following single dose inhalation in patients with COPD.
The secondary objectives were to characterize the pharmacokinetics of salmeterol inhalation powder delivered by HandiHaler® 2 from the PE hard capsule and salmeterol xinafoate delivered by Serevent® Diskus®, and to compare the safety of the two pharmaceutical forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Salmeterol xinafoate | Experimental | Drug: Salmeterol xinafoate, Drug: Placebo (Diskus®)25 μg Salmeterol inhalation powder administered via HandiHaler® |
| Serevent® Diskus® | Active comparator | Drug: Serevent® Diskus®, Drug: Placebo (HandiHaler®)50 μg Salmeterol (dry powder inhaler) administered via Diskus® |
| Placebo | Placebo comparator | Drug: Placebo (HandiHaler®), Drug: Placebo (Diskus®) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- At Visit 1, patients must demonstrate an improvement in FEV1 of ≥ 12% over the pre-bronchodilator value 45 minutes after inhalation of 4 puffs of 100 μg salbutamol (Sultanol® MDI)
- Male or female patients 40 years of age or older
- Patients must be current or ex-smokers with a smoking history of more than 10 pack-years ((Patients who have never smoked cigarettes must be excluded)
Key exclusion criteria (23 listed)
- Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
- Patients with a recent history (i.e., six months or less) of myocardial infarction
- Patients who have been hospitalized for heart failure (New York Heart Association (NYHA) class III or IV) within the past year
- Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
- Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed
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 |
|---|---|---|
| Salmeterol xinafoate | Drug | Salmeterol xinafoate |
| Serevent® Diskus® | Drug | Serevent® Diskus® |
| Placebo (HandiHaler®) | Drug | Placebo, Serevent® Diskus® |
| Placebo (Diskus®) | Drug | Placebo, Salmeterol xinafoate |
Primary outcome
Change in area under the curve for the time period 0 to 12 hours (AUC0-12h) of the forced expiratory volume in one second (FEV1)
Time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing
23 secondary outcomes
Change in peak FEV1
Time frame: within 3 hours post-dosing
Change in FEV1 AUC12-24h
Time frame: 12, 14, 22, 23 and 24 hours post-dosing
Change in FEV1 AUC0-24h
Time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Individual FEV1 measurements at each time point
Time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Change in forced vital capacity (FVC) AUC0-12h
Time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing
Change in peak FVC
Time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Change in FVC AUC12-24h
Time frame: 12, 14, 22, 23 and 24 hours post-dosing
Change in FVC AUC0-24h
Time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Individual FVC measurements at each time point
Time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, 12, 14, 22, 23 and 24 hours post-dosing
Number of patients with adverse events
Time frame: up to 23 days
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2; a time interval from 0 - 8 h is appropriate)
Time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
λz (terminal rate constant in plasma)
Time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
t½ (terminal half-life of the analyte in plasma)
Time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
MRTih (mean residence time of the analyte in the body after inhalational administration)
Time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: pre-dose and 2, 5, 10, 17, 25, 40 minutes, and 1h 5min, 1h 35 min, 3h 5min, 6h 5min, and 8h 5 min following drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time interval t1 to t2)
Time frame: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
Time frame: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
Time frame: 0 to 3h 5min, from 3h 5min to 6h 5min, and from 6h 5min to 8h 5min after administration
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 17 Sep 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Salmeterol xinafoate and Serevent® Diskus® in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
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 9 inclusion and 23 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 17 Sep 2014. 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. 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 area under the curve for the time period 0 to 12 hours (AUC0-12h) of the forced expiratory volume in one second (FEV1) (time frame: Pre-dose and 15, 30, 60 minutes, 2, 3, 4, 6, 8, 10, and 12 hours post-dosing). 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 17 Sep 2014.