A Phase 2 interventional study of Aclidinium Bromide/Formoterol Fumarate 400/12μg BID in Pulmonary Disease, Chronic Obstructive, sponsored by AstraZeneca. Completed at 1 site in China. Open to participants aged 40 Years to 130 Years. Per ClinicalTrials.gov, last updated 2019-07-22.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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Among 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca — 14 open to participants now, 15 under way, 4 of them phase 3. Pulmonary Disease, Chronic Obstructive · AstraZeneca.
Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, this one is the 179th largest by enrollment of the 194 interventional ones that give a count, is one of 14 that started in 2017, is one of 54 in phase 2, and was the 209th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →14 of the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
AstraZeneca · Sites in France
Ages 18–99
AstraZeneca · Sites in India
Ages 18+
AstraZeneca · Sites in Argentina, Egypt, Mexico and 4 more countries
Ages 18+
AstraZeneca · Sites in Argentina, Colombia, Egypt and 9 more countries
Ages 30–80
By country, each count listing its studies:
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 40 Years to 130 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
284 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 57 · Phase 3 77 · Phase 4 19
First in 1999; this study’s year is marked. 14 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 20 is below the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 137 across the 194 interventional studies, 976 across the 89 observational. Of the 264 that completed or were terminated, 127 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
9 of the studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06712563AstraZenecaPooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting | 2026-12-14 |
| NCT07245576AstraZenecaAssess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis | 2027-04-30 |
| NCT07315958AstraZenecaStudy for Assessing the Prevalence of Airflow Limitation in Outpatients With History of Smoking Attending Cardiology Clinics | 2027-04-30 |
| NCT07073950AstraZenecaA Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation | 2027-05-31 |
| NCT07307781AstraZenecaStudy of Patient With Frequent Exacerbations in Moscow | 2027-06-25 |
Add all 9 to your calendar (.ics) → With an account.
Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A Phase IIa, open-label, repeat-dose trial to investigate the pharmacokinetics (PK), safety and tolerability of single and multiple twice daily doses of inhaled Aclidinium Bromide/Formoterol Fumarate 400/12 μg in 20 Chinese male and female patients with stable moderate to severe COPD.
Screening will be performed within 21 days of dosing on Day 1 at visit 2. Eligible participants will be admitted to the trial center the day preceding the first dosing (day -1).
Participants will receive Aclidinium Bromide/Formoterol Fumarate 400/12 μg twice-daily (morning and evening) on Days 1 to 4. On Day 5 patients will receive the morning dose only. PK and safety assessments will be conducted at specific timepoints on Day 1 to Day 7.
Participants will be discharged 48 h after the last administration of investigational product and completion of the 48-h PK sample collection and safety assessments on Day 7.
A follow-up visit will be performed within 5 days of the last PK sample collection on Day 7.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Aclidinium bromide/Formoterol Fumarate 400/12μg inhalation powder twice-daily. Oral inhalation via Genuair® dry powder inhaler (DPI).
Drug: Aclidinium Bromide/Formoterol Fumarate 400/12μg BID
Aclidinium bromide/formoterol fumarate 400/12μg administered by inhalation via the Genuair® multidose dry powder inhaler, twice daily (morning and evening) for 5 days
Cmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).
Observed maximum concentration, taken directly from the individual concentration-time curve (first dose).
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1
Tmax of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).
Time to maximum concentration (h), taken directly from the individual concentration-time curve (first dose).
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1
Cmin of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).
Minimum plasma drug concentration at the end of the dosing interval (first dose), where possible.
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1
AUC(Last) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration.
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1
AUC(Tau) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Single Dose).
Area under the plasma concentration curve during the first dosing interval, tau (first dose).
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, and 12 hours post the morning dose on Day 1
Css,Max of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Observed maximum concentration, taken directly from the individual concentration-time curve at steady state.
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
Css,Min of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Observed minimum concentration, taken directly from the individual concentration-time curve within a dosing interval on Day 5.
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
Tss,Max of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Time to maximum concentration (h), taken directly from the individual concentration-time curve at steady state.
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
λz of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Terminal rate constant, estimated by log-linear least square regression of the terminal part of the concentration-time curve.
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
t½λz of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Terminal half-life (h), estimated as (ln2)/λz.
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
AUC(ss,Tau) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Area under the plasma concentration curve during the dosing interval, tau at steady state.
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
CL/F of Aclidinium Bromide and Formoterol Fumarate (Multiple Doses).
Apparent plasma clearance for parent drug estimated as dose divided by AUCss
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
Vz/F of Aclidinium Bromide and Formoterol Fumarate (Multiple Doses).
Apparent volume of distribution for parent drug at terminal phase, estimated by dividing the apparent clearance (CL/F) by λz.
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
Cav of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Average plasma concentration during a dosing interval, estimated as AUC(ss,tau)/12
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
%Fluctuation of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Fluctuation index during a dosing interval estimated as 100\*(Cmax-Cmin)/Cav (%).
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
Rac(Cmax) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Accumulation ratio for Cmax estimated as Css,max on Day 5/Cmax on Day 1
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
Rac[AUC(Tau)] of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Accumulation ratio for AUC(tau) estimated as AUC(ss,tau) on Day 5/AUC(tau) on Day 1
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
Rac(Cmin) of Aclidinium Bromide, Its Metabolites and Formoterol Fumarate (Multiple Doses).
Accumulation ratio for Cmin estimated as Css,min on Day 5/Cmin on Day 1. Additional parameters may be determined where appropriate.
Time frame: Pre-dose and 5, 15, and 30 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post the morning dose on Day 5
Adverse Events (AEs)/Serious AEs (SAEs)
Assessment of the safety in terms of the incidences of AEs/SAEs after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
Time frame: Screening (Day -21) to Follow-up visit (Days 8-12)
Treatment-emergent AEs Related to Blood Pressure
Assessment of the safety in terms of notable changes from baseline in blood pressure after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
Time frame: Screening (Day -21) to Follow-up visit (Days 8-12)
Treatment-emergent AEs Related to Clinical Laboratory Parameters (Haematology)
Assessment of the safety in terms of haematology parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
Time frame: Screening (Day -21) to Follow-up visit (Days 8-12)
Treatment-emergent AEs Related to Clinical Laboratory Parameters (Urinalysis)
Assessment of the safety in terms of urinalysis parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
Time frame: Screening (Day -21) to Follow-up visit (Days 8-12)
Treatment-emergent AEs Related to Clinical Laboratory Parameters (Serum Biochemistry)
Assessment of the safety in terms of serum biochemistry parameters (Alanine aminotransferase \[ALT\], Aspartate aminotransferase \[AST\], alkaline phosphatase \[ALP\], Gamma-glutamyl transferase \[GGT\], bilirubin, creatine kinase, lactate dehydrogenase, urea nitrogen, creatinine, urate, cholesterol, glucose, sodium, potassium, calcium, chloride, phosphate, protein, and albumin) after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
Time frame: Screening (Day -21) to Follow-up visit (Days 8-12)
Treatment-emergent AEs Related to 12-lead ECG Parameters
Assessment of the safety in terms of the 12-lead ECG parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
Time frame: Screening (Day -21) to Follow-up visit (Days 8-12)
This study was conducted at a single centre in China. The first participant was enrolled in December 2017 and the last participant visit was in June 2018.
| Milestone | AB/FF 400/12 BID |
|---|---|
| Started | 20 |
| Completed | 19 |
| Not completed | 1 |
| Withdrew: Adverse event | 1 |
Observed maximum concentration, taken directly from the individual concentration-time curve (first dose).
| pg/mL | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 45.82 ± 84.54 |
| LAS34850 | 3149 ± 55.56 |
| LAS34823 | 38.82 ± 86.60 |
| Formoterol Fumarate | 4.786 ± 62.78 |
Time to maximum concentration (h), taken directly from the individual concentration-time curve (first dose).
| hours | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 0.08 (0.08 to 0.50) |
| LAS34850 | 3.00 (1.50 to 6.00) |
| LAS34823 | 1.75 (0.08 to 4.00) |
| Formoterol Fumarate | 1.00 (0.08 to 3.00) |
Minimum plasma drug concentration at the end of the dosing interval (first dose), where possible.
| pg/mL | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide Not calculable | 0 ± 0 |
| LAS34850 | 627.7 ± 52.02 |
| LAS34823 Not calculable | 0 ± 0 |
| Formoterol Fumarate Not calculable | 0 ± 0 |
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration.
| pg*hour/mL | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 78.61 ± 90.69 |
| LAS34850 | 20280 ± 54.28 |
| LAS34823 | 201.1 ± 106.3 |
| Formoterol Fumarate | 20.04 ± 64.22 |
Area under the plasma concentration curve during the first dosing interval, tau (first dose).
| pg*hour/mL | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 85.45 ± 79.02 |
| LAS34850 | 20330 ± 54.24 |
| LAS34823 | 252.9 ± 60.63 |
| Formoterol Fumarate | 22.78 ± 43.64 |
Observed maximum concentration, taken directly from the individual concentration-time curve at steady state.
| pg/mL | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 60.86 ± 150.0 |
| LAS34850 | 3691 ± 56.03 |
| LAS34823 | 81.02 ± 69.52 |
| Formoterol Fumarate | 6.465 ± 84.34 |
Observed minimum concentration, taken directly from the individual concentration-time curve within a dosing interval on Day 5.
| pg/mL | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 4.528 ± 47.34 |
| LAS34850 | 1032 ± 43.05 |
| LAS34823 | 22.88 ± 47.22 |
| Formoterol Fumarate | 1.281 ± 36.63 |
Time to maximum concentration (h), taken directly from the individual concentration-time curve at steady state.
| hours | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 0.08 (0.08 to 0.50) |
| LAS34850 | 3.00 (0.08 to 4.00) |
| LAS34823 | 0.50 (0.08 to 3.00) |
| Formoterol Fumarate | 0.08 (0.08 to 1.50) |
Terminal rate constant, estimated by log-linear least square regression of the terminal part of the concentration-time curve.
| 1/hours | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 0.053 ± 0.040 |
| LAS34850 | 0.045 ± 0.018 |
| LAS34823 | 0.048 ± 0.021 |
| Formoterol Fumarate | 0.057 ± 0.029 |
Terminal half-life (h), estimated as (ln2)/λz.
| hours | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 19.42 ± 11.10 |
| LAS34850 | 20.95 ± 18.78 |
| LAS34823 | 17.34 ± 8.096 |
| Formoterol Fumarate | 14.06 ± 4.796 |
Area under the plasma concentration curve during the dosing interval, tau at steady state.
| pg*hour/mL | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 168.8 ± 82.15 |
| LAS34850 | 27300 ± 52.29 |
| LAS34823 | 540.9 ± 54.97 |
| Formoterol Fumarate | 31.98 ± 51.60 |
Apparent plasma clearance for parent drug estimated as dose divided by AUCss
| L/hour | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 3140 ± 2868 |
| Formoterol Fumarate | 422.2 ± 222.7 |
Apparent volume of distribution for parent drug at terminal phase, estimated by dividing the apparent clearance (CL/F) by λz.
| L | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 81990 ± 87200 |
| Formoterol Fumarate | 8284 ± 5161 |
Average plasma concentration during a dosing interval, estimated as AUC(ss,tau)/12
| pg/mL | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 14.07 ± 82.15 |
| LAS34850 | 2275 ± 52.29 |
| LAS34823 | 45.07 ± 54.97 |
| Formoterol Fumarate | 2.665 ± 51.60 |
Fluctuation index during a dosing interval estimated as 100\*(Cmax-Cmin)/Cav (%).
| Percentage | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 452.5 ± 269.4 |
| LAS34850 | 117.0 ± 24.69 |
| LAS34823 | 132.0 ± 57.81 |
| Formoterol Fumarate | 205.9 ± 90.94 |
Accumulation ratio for Cmax estimated as Css,max on Day 5/Cmax on Day 1
| ratio | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 1.297 ± 216.6 |
| LAS34850 | 1.185 ± 80.29 |
| LAS34823 | 2.070 ± 113.5 |
| Formoterol Fumarate | 1.384 ± 90.21 |
Accumulation ratio for AUC(tau) estimated as AUC(ss,tau) on Day 5/AUC(tau) on Day 1
| ratio | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 1.966 ± 108.9 |
| LAS34850 | 1.355 ± 76.54 |
| LAS34823 | 2.157 ± 82.00 |
| Formoterol Fumarate | 1.436 ± 56.27 |
Accumulation ratio for Cmin estimated as Css,min on Day 5/Cmin on Day 1. Additional parameters may be determined where appropriate.
| ratio | AB/FF 400/12 BID |
|---|---|
| Aclidinium Bromide | 1.877 ± 45.19 |
| LAS34850 | 1.641 ± 69.91 |
| LAS34823 | 2.601 ± 54.86 |
| Formoterol Fumarate | 1.822 ± 31.43 |
Assessment of the safety in terms of the incidences of AEs/SAEs after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
| Participants | AB/FF 400/12 BID |
|---|---|
| Any AE | 5 |
| Any SAE | 1 |
Assessment of the safety in terms of notable changes from baseline in blood pressure after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
| Participants | AB/FF 400/12 BID |
|---|---|
| Blood pressure increased | 1 |
Assessment of the safety in terms of haematology parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
| Participants | AB/FF 400/12 BID |
|---|---|
| Treatment-emergent AEs Related to Clinical Laboratory Parameters (Haematology) | 0 |
Assessment of the safety in terms of urinalysis parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
| Participants | AB/FF 400/12 BID |
|---|---|
| Urine protein present | 3 |
| Haematuria | 1 |
Assessment of the safety in terms of serum biochemistry parameters (Alanine aminotransferase \[ALT\], Aspartate aminotransferase \[AST\], alkaline phosphatase \[ALP\], Gamma-glutamyl transferase \[GGT\], bilirubin, creatine kinase, lactate dehydrogenase, urea nitrogen, creatinine, urate, cholesterol, glucose, sodium, potassium, calcium, chloride, phosphate, protein, and albumin) after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
| Participants | AB/FF 400/12 BID |
|---|---|
| Treatment-emergent AEs Related to Clinical Laboratory Parameters (Serum Biochemistry) | 0 |
Assessment of the safety in terms of the 12-lead ECG parameters after administration of Aclidinium Bromide/Formoterol Fumarate 400/12 μg BID for 5 days.
| Participants | AB/FF 400/12 BID |
|---|---|
| Treatment-emergent AEs Related to 12-lead ECG Parameters | 0 |
Collected over Screening (Day -21) to Follow-up visit (Days 8-12). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AB/FF 400/12 BID | 0/20 (0%) | 1/20 (5%) | 3/20 (15%) |
| Event | AB/FF 400/12 BID |
|---|---|
| BronchitisInfections and infestations | 1/20 |
| Event | AB/FF 400/12 BID |
|---|---|
| Protein urine presentInvestigations | 3/20 |
Safety analysis set: Includes all participants who received at least one dose of investigational product.
| Age, Continuous(Years) | AB/FF 400/12 BID |
|---|---|
| Mean | 59.2 ± 6.8 |
| Sex: Female, Male(Participants) | AB/FF 400/12 BID |
|---|---|
| Female | 5 |
| Male | 15 |
| Race (NIH/OMB)(Participants) | AB/FF 400/12 BID |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 20 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2017 to primary completion in Jun 2018, 6 months.
Results were first posted in Jul 2019, 1 year 1 month after primary completion.
Of 118 industry-sponsored phase 2 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 20. This study's 6 months is below that.
Counting every sponsor, half of 165 studies reached it within 17 months; a quarter within 10 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →