Chronic Obstructive Pulmonary DiseasePhase 2NCT01566773
PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
A Phase 2 study testing PT001 MDI and Tiotropium Bromide in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 10 sites in United States.
Trial summary
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- PT001 MDI and Tiotropium Bromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2012to Aug 2012
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- 40 - 80 years of age
- Clinical history of COPD with airflow limitation that is not fully reversible
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
- A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70
- A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values
- Able to change COPD treatment as required by protocol
Who cannot join
- Women who are pregnant or lactating
- Primary diagnosis of asthma
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Active pulmonary diseases
- Prior lung volume reduction surgery
- Abnormal chest X-ray (or CT scan) not due to the presence of COPD
Show all 11Show fewer
- Hospitalized due to poorly controlled COPD within 3 months of Screening
- Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
- Cancer that has not been in complete remission for at least 5 years
- Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
- Other inclusion/exclusion criteria as defined in the protocol
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Pearl Investigative Site
Charlotte, North Carolina, 28207
Pearl Investigative Site
Clearwater, Florida, 33765
Pearl Investigative Site
Fullerton, California, 92835
Pearl Investigative Site
Longview, Texas, 75605
Pearl Investigative Site
Medford, Oregon, 97504
Pearl Investigative Site
Panama City, Florida, 32405
Pearl Investigative Site
Richmond, Virginia, 23225
Pearl Investigative Site
Spartanburg, South Carolina, 29303
Pearl Investigative Site
Tampa, Florida, 33603
Pearl Investigative Site
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, Open Label) as An Active Control
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
Read the detailed description
The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- PT001 MDI, Tiotropium Bromide, PT001 Placebo MDI
- Keywords
- COPD
- 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.
PT001 MDIDrug
Administered as two puffs BID for 14 days
Tiotropium BromideDrug
Also called Spiriva® Handihaler®
Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
PT001 Placebo MDIDrug
| Study group | Role | What they receive |
|---|---|---|
| PT001 MDI (Dose 1) | Experimental | Not described Receives: Drug: PT001 MDI |
| PT001 MDI (Dose 2) | Experimental | Not described Receives: Drug: PT001 MDI |
| PT001 MDI (Dose 3) | Experimental | Not described Receives: Drug: PT001 MDI |
| PT001 MDI (Dose 4) | Experimental | Not described Receives: Drug: PT001 MDI |
| PT001 MDI (Dose 5) | Experimental | Not described Receives: Drug: PT001 MDI |
| PT001 MDI (Dose 6) | Experimental | Not described Receives: Drug: PT001 MDI |
| PT001 Placebo MDI | Placebo comparator | Not described Receives: Drug: PT001 Placebo MDI |
| Spiriva® Handihaler® (Tiotropium Bromide) | Active comparator | Not described Receives: Drug: Tiotropium Bromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 AUC0-12
Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.
Measured: Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)
Secondary outcomes (24)
Peak Change From Baseline in FEV1
Highest value of FEV1 post dose on day 1
Measured: Day 1
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
Time to Onset of Action (>10% Improvement in FEV1) on Day 1.
Measured: Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs)
Percentage of Subjects Achieving at Least 12% Improvement in FEV1
Percentage of subjects achieving at least 12% improvement in FEV1.
Measured: Day 1
Peak Change From Baseline in Inspiratory Capacity (IC)
Peak change in Inspiratory Capacity (IC) mean of 1 and 2 hour post-dose assessments minus the baseline
Measured: Day 1 (1 hr and 2 hr post-dose )
Change From Baseline in Morning Pre-dose Trough FEV1
Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
Measured: Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
Peak Change From Baseline in FEV1
Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)
Measured: Day 7
Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)
Change from baseline in morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Measured: Day 7
Peak Change From Baseline in IC
Peak change from baseline in IC (mean of 1 hr and 2 hr post-dose assessments)
Measured: Day 7 (mean of 1 hr and 2 hr post-dose assessments)
Change From Baseline in Mean Morning Pre-dose Daily PEFR
Change from baseline in mean morning pre-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])
Measured: Day 7 (60 minutes pre-dose, 30 minutes pre-dose)
Change From Baseline in Morning Post-dose Daily PEFR
Change from baseline in morning post-dose daily PEFR (peak expiratory flow rate) taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (excluding reading taken pre-dose on Visit 2 [Treatment Day 1])
Measured: Day 7 (30 minutes post-dose)
Change From Baseline in Mean Evening Pre-dose PEFR
Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)
Measured: Day 7
Change From Baseline in Mean Evening Post-dose PEFR
Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries, up through Diary Day 7 of each treatment period (subjects taking Spiriva performed a single evening assessment)
Measured: Day 7
Mean Number of Puffs of Rescue Medication
Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated
Measured: Day 7
Change From Baseline in Morning Pre-dose Trough FEV1
Change from baseline in morning pre-dose trough FEV1 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)
Measured: Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)
Peak Change From Baseline in FEV1
Peak change from baseline in FEV1 (defined as the change at the highest value of FEV1 post-dose minus the baseline)
Measured: Day 14
Change From Baseline for Mean Morning Pre-dose Trough IC
Change from baseline for mean morning pre-dose trough IC (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Measured: Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Peak Change From Baseline in IC
Peak change from baseline in IC (mean of 1 and 2 hour post-dose assessments minus the baseline)
Measured: Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)
Change From Baseline in 12-hour Post-dose Trough FEV1
12-hour post-dose trough FEV1 was defined as the mean of the FEV1 assessments taken at 11.5 and 12 hours post-dose minus the baseline
Measured: Day 14 (Baseline, 11.5 and 12 hours post dose)
Change From Baseline in Mean Morning Pre-dose Daily PEFR
Change from baseline in mean morning pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]
Measured: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Change From Baseline in Mean Morning Post-dose Daily PEFR
Change from baseline in mean morning post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (mean reading excluded reading taken pre-dose on Visit 2 [Treatment 1 Day 1]
Measured: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Change From Baseline in Mean Evening Pre-dose Daily PEFR
Change from baseline in mean evening pre-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)
Measured: Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Change From Baseline in Mean Evening Post-dose Daily PEFR
Change from baseline in mean evening post-dose daily peak flow readings taken by subjects and recorded in subject diaries during each treatment period for subjects with more than 7 days of diary data (subjects taking Spiriva performed a single evening assessment)
Measured: Through the end of the 14-Day Treatment
Mean Number of Puffs of Rescue Medication (End of Treatment)
Mean number of puffs of rescue medication recorded in subject diaries during each treatment period and by treatment and numbers of days treated
Measured: Day 14 (End of treatment)
Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14
Change from Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14
Measured: Day 1 through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012
- Study completionAug 2012
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 Chronic Obstructive Pulmonary DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Reisner, MD, Study director, Pearl Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566773
- Sponsor's protocol ID
- PT001003
- Status last verified
- Oct 2017
- First submitted
- 27 Mar 2012
- Last updated
- 12 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fabbri LM, Kerwin EM, Spangenthal S, Ferguson GT, Rodriguez-Roisin R, Pearle J, Sethi S, Orevillo C, Darken P, St Rose E, Fischer T, Golden M, Dwivedi S, Reisner C. Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD. Respir Res. 2016 Sep 2;17(1):109. doi: 10.1186/s12931-016-0426-4.
PubMed 27586537
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, Open Label) as An Active Control
- ClinicalTrials.gov ID
- NCT01566773
- Acronym / sponsor ID
- PT001003
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 12 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
Detailed description
The primary objective of this study is to assess efficacy relative to placebo of GP MDI in subjects with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this protocol. To this end, each dose of GP MDI will be compared to placebo with respect to the primary efficacy endpoint, FEV1 AUC0-12 relative to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| PT001 MDI (Dose 1) | Experimental | Drug: PT001 MDI |
| PT001 MDI (Dose 2) | Experimental | Drug: PT001 MDI |
| PT001 MDI (Dose 3) | Experimental | Drug: PT001 MDI |
| PT001 MDI (Dose 4) | Experimental | Drug: PT001 MDI |
| PT001 MDI (Dose 5) | Experimental | Drug: PT001 MDI |
| PT001 MDI (Dose 6) | Experimental | Drug: PT001 MDI |
| PT001 Placebo MDI | Placebo comparator | Drug: PT001 Placebo MDI |
| Spiriva® Handihaler® (Tiotropium Bromide) | Active comparator | Drug: Tiotropium Bromide |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed written informed consent
- 40 - 80 years of age
- Clinical history of COPD with airflow limitation that is not fully reversible
- Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
- Current/former smokers with at least a 10 pack-year history of cigarette smoking
Key exclusion criteria (11 listed)
- Women who are pregnant or lactating
- Primary diagnosis of asthma
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Active pulmonary diseases
- Prior lung volume reduction surgery
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 |
|---|---|---|
| PT001 MDIAdministered as two puffs BID for 14 days | Drug | PT001 MDI (Dose 1), PT001 MDI (Dose 2), PT001 MDI (Dose 3), PT001 MDI (Dose 4), PT001 MDI (Dose 5), PT001 MDI (Dose 6) |
| Tiotropium BromideAlso: Spiriva® Handihaler®Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI | Drug | Spiriva® Handihaler® (Tiotropium Bromide) |
| PT001 Placebo MDI | Drug | PT001 Placebo MDI |
Primary outcome
FEV1 AUC0-12
Time frame: Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)
Forced expiratory volume in 1 second (FEV1) normalized area under the curve 0-12 hours (AUC0-12) following chronic dosing for 14 days.
24 secondary outcomes
Peak Change From Baseline in FEV1
Time frame: Day 1
Time to Onset of Action (>10% Improvement in FEV1) on Day 1
Time frame: Day 1 (15 min, 30 min, 1 hr, 2 hrs, no onset within 2 hrs)
Percentage of Subjects Achieving at Least 12% Improvement in FEV1
Time frame: Day 1
Peak Change From Baseline in Inspiratory Capacity (IC)
Time frame: Day 1 (1 hr and 2 hr post-dose )
Change From Baseline in Morning Pre-dose Trough FEV1
Time frame: Day 7 (average of the 60 and 30-minute pre-dose values on Treatment Day 7 minus the baseline)
Peak Change From Baseline in FEV1
Time frame: Day 7
Change From Baseline in Morning Pre-dose Trough Inspiratory Capacity (IC)
Time frame: Day 7
Peak Change From Baseline in IC
Time frame: Day 7 (mean of 1 hr and 2 hr post-dose assessments)
Change From Baseline in Mean Morning Pre-dose Daily PEFR
Time frame: Day 7 (60 minutes pre-dose, 30 minutes pre-dose)
Change From Baseline in Morning Post-dose Daily PEFR
Time frame: Day 7 (30 minutes post-dose)
Change From Baseline in Mean Evening Pre-dose PEFR
Time frame: Day 7
Change From Baseline in Mean Evening Post-dose PEFR
Time frame: Day 7
Mean Number of Puffs of Rescue Medication
Time frame: Day 7
Change From Baseline in Morning Pre-dose Trough FEV1
Time frame: Day 14 (average of the 60 and 30-minute pre-dose values on Treatment Day 14 minus the baseline)
Peak Change From Baseline in FEV1
Time frame: Day 14
Change From Baseline for Mean Morning Pre-dose Trough IC
Time frame: Day 14 (average of the 60 and 30-minute pre-dose assessments minus the baseline)
Peak Change From Baseline in IC
Time frame: Day 14 (mean of 1 and 2 hour post-dose assessments minus the baseline)
Change From Baseline in 12-hour Post-dose Trough FEV1
Time frame: Day 14 (Baseline, 11.5 and 12 hours post dose)
Change From Baseline in Mean Morning Pre-dose Daily PEFR
Time frame: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period before dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Change From Baseline in Mean Morning Post-dose Daily PEFR
Time frame: Baseline, Treatment Day 1 and every day, to the end of the 14-Day Treatment period 30 minutes post dosing, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Change From Baseline in Mean Evening Pre-dose Daily PEFR
Time frame: Treatment Day 1 to the end of the 14-Day Treatment, values were averaged for the end of treatment value (all subjects with diary data after Diary day 7)
Change From Baseline in Mean Evening Post-dose Daily PEFR
Time frame: Through the end of the 14-Day Treatment
Mean Number of Puffs of Rescue Medication (End of Treatment)
Time frame: Day 14 (End of treatment)
Change From Baseline in Morning Pre-dose Trough FEV1 (mL) Averaging Treatment Day 7 and Day 14
Time frame: Day 1 through Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27586537Fabbri LM, Kerwin EM, Spangenthal S, Ferguson GT, Rodriguez-Roisin R, Pearle J, Sethi S, Orevillo C, Darken P, St Rose E, Fischer T, Golden M, Dwivedi S, Reisner C. Dose-response to inhaled glycopyrrolate delivered with a novel Co-Suspension Delivery Technology metered dose inhaler (MDI) in patients with moderate-to-severe COPD. Respir Res. 2016 Sep 2;17(1):109. doi: 10.1186/s12931-016-0426-4.
- protocol-pt001003\_FINAL\_RedactedLink 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.
Colin Reisner, MD study director
Pearl Therapeutics, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PT001 MDI and Tiotropium Bromide in people with Chronic Obstructive Pulmonary Disease, run by Pearl Therapeutics, Inc. at 10 sites in United States.
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 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 12 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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 12 Oct 2017). 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?
FEV1 AUC0-12 (time frame: Day 14 (-1 hr, -30 min, 15 min, 30 min, 1 hr, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr, 11.5 hr, 12 hr)). 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 NCT01566773, 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 12 Oct 2017.