AsthmaPhase 2NCT01993329

A Study to Evaluate the Effect of Gefapixant (AF-219/MK-7264) on Methacholine Hyper-reactivity in Participants With Asthma (MK-7264-009)

A Phase 2 study testing Gefapixant 50 mg and Gefapixant 300 mg in people with Asthma, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, single centre study in participants with asthma undergoing inhalation of methacholine and adenosine triphosphate (ATP) to assess the provocative concentration (PC20) response of two dose levels of gefapixant (AF-219) compared… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: Gefapixant 50 mg and Gefapixant 300 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: No sites listed yet
Study dates: 16 Dec 2013to 28 Feb 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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Women of child-bearing potential (WOCBP) (i.e., women who are not surgically sterile, not having had hysterectomy, bilateral tubal occlusion or bilateral oophorectomy, or are not postmenopausal) must have a negative pregnancy test at Screening and prior to randomization. WOCBP must be using 2 forms of acceptable birth control method from Screening through the Follow-Up Visit. Acceptable birth control methods include (of which 2 must be used):
Established use of oral, injected or implanted hormonal methods of contraception
Intrauterine device (IUD) or intrauterine system (IUS)
Condom with spermicide
Diaphragm with spermicide
Double-barrier method (diaphragm for female participant and condom for male partner with spermicidal) satisfies the requirement for 2 forms of acceptable birth control. When in line with the preferred lifestyle of the participant, true and complete abstinence (not periodic abstinence) is acceptable.

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Male participants with partners WOCBP (as defined in Inclusion No. 2) must use 2 methods of acceptable birth control with their partner, 1 of which must be a barrier method. Contraception must start from screening and continue until 3 months after last dose of study drug.
Non-smokers or former smokers, who stopped smoking 6 months prior to screening. Former smokers should not have a smoking history of more than 5 pack years (1 pack of 20 cigarettes per day over 5 years).
Physician documented history or diagnosis of asthma for at least 6 months prior to screening according to the Global Initiative in Asthma guidelines (GINA, 2012).
Requires the use of Short acting β2-agonist therapy only (≤ 8 puffs per day) for at least 4 weeks prior to screening and prior to randomization.

Who cannot join

Has been hospitalized or attended the emergency department for an asthma attack in the 12 months prior to screening.
Exacerbation of asthma or lower respiratory tract infection during the 4 weeks before screening or prior to randomization.
Upper respiratory tract infection during the 4 weeks before screening or prior to randomization requiring treatment with antibiotics.
Inhaled or systemic corticosteroids (oral, intravenous, intramuscular) within 4 weeks prior to screening or prior to randomization.
Short-acting or long-acting antihistamines within 48hrs or 7 days, respectively, prior to screening.
Body mass index (BMI) <18 kg/m2 or ≥ 35 kg/m2 at screening.

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History of kidney/bladder stones (nephro/uro-lithiasis) within 5 years of screening.
History of conditions or disorders that predispose to nephrolithiasis, such as Type 1 renal tubular acidosis, cystinuria, gout, hyperparathyroidism, inflammatory bowel disease (i.e., ulcerative colitis and Crohn's disease), short bowel syndrome, or bariatric surgery.
History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening (not including participants with basal cell carcinomas or cervical carcinoma in situ that has been successfully treated surgically).
Personal or family history of congenital long QT Interval on ECG (QT) syndrome.
Presence of a cardiac pacemaker.
History of a diagnosis of drug or alcohol dependency or abuse within approximately the last 3 years.
Diagnosis of depression, psychosis, bipolar disorder, or schizoaffective disorder.
Participants with diabetes Type I or uncontrolled diabetes Type II or Glycosylated Hemoglobin (HbA1c) > 8.0% at screening.
Any condition possibly affecting drug absorption e.g., gastrectomy, gastroplasty, any type of bariatric surgery, vagotomy, or bowel resection.
History of cutaneous adverse drug reaction to sulphonamides or signs or symptoms suggestive of anaphylaxis to sulphonamides.
Requiring concomitant therapy with prohibited medications at screening or prior to randomization.
Pregnant or breastfeeding woman.
Donation of sperm from Screening until 3 months after the last dose of study drug.
Male participants with pregnant female partners.
Treatment with an investigational drug within 30 days or five half-lives preceding the first dose of study medication or plans to take another investigational drug within 30 days of study completion.
Donation or loss of 400 mL or more of blood or donations of plasma within eight (8) weeks prior to initial dosing or longer if required by local regulation.

About this study

Official title: A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-over Study to Evaluate the Effect of AF-219 on Methacholine Hyper-Reactivity in Subjects With Asthma

Conditions: Asthma
Being tested: Gefapixant 50 mg, Gefapixant 300 mg, Placebo to mimic 50 mg tablets, Placebo to mimic 300 mg tablets
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gefapixant 50 mgDrug
Also called AF-219, MK-7264
Gefapixant 50 mg tablet administered orally
Gefapixant 300 mgDrug
Also called AF-219, MK-7264
Gefapixant 300 mg tablet administered orally
Placebo to mimic 50 mg tabletsDrug
Sugar pill manufactured to mimic gefapixant 50 mg tablets
Placebo to mimic 300 mg tabletsDrug
Sugar pill manufactured to mimic gefapixant 300 mg tablets

Study groups in NCT01993329
Study group	Role	What they receive
Gefapixant 50/ Gefapixant 300/ Placebo	Experimental	Gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 1, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 2, placebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period. Receives: Drug: Gefapixant 50 mg; Drug: Gefapixant 300 mg; Drug: Placebo to mimic 50 mg tablets; Drug: Placebo to mimic 300 mg tablets
Gefapixant 50/ Placebo/ Gefapixant 300	Experimental	Gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 1, placebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 2, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period. Receives: Drug: Gefapixant 50 mg; Drug: Gefapixant 300 mg; Drug: Placebo to mimic 50 mg tablets; Drug: Placebo to mimic 300 mg tablets
Gefapixant 300/ Gefapixant 50/ Placebo	Experimental	Gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 1, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 2, placebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period. Receives: Drug: Gefapixant 50 mg; Drug: Gefapixant 300 mg; Drug: Placebo to mimic 50 mg tablets; Drug: Placebo to mimic 300 mg tablets
Gefapixant 300/ Placebo/ Gefapixant 50	Experimental	Gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 1, placebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 2, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period. Receives: Drug: Gefapixant 50 mg; Drug: Gefapixant 300 mg; Drug: Placebo to mimic 50 mg tablets; Drug: Placebo to mimic 300 mg tablets
Placebo/ Gefapixant 50/ Gefapixant 300	Experimental	Placebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 1, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 2, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period. Receives: Drug: Gefapixant 50 mg; Drug: Gefapixant 300 mg; Drug: Placebo to mimic 50 mg tablets; Drug: Placebo to mimic 300 mg tablets
Placebo/ Gefapixant 300/ Gefapixant 50	Experimental	Placebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 1, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 2, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period. Receives: Drug: Gefapixant 50 mg; Drug: Gefapixant 300 mg; Drug: Placebo to mimic 50 mg tablets; Drug: Placebo to mimic 300 mg tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Provocative Concentration (PC20) After Methacholine Challenge
The provocative concentration (PC) of inhaled methacholine required to reduce forced expiratory volume in 1 second (FEV1) by 20% (PC20) was calculated from the methacholine challenge at screening and 2 hours (+15 minutes) post dose on Day 3 of each Treatment Period using a five-breath dosimeter method. The primary endpoint was the methacholine PC20 value normalized by means of a log (base 2) transformation, at 2 dose levels compared with placebo in participants with asthma following provocation with methacholine.
Measured: Screening (Day -21 to Day -1) and Day 3

Secondary outcomes (1)

Highest FEV1 After Methacholine Challenge
Serial FEV1 was measured post inhalation of methacholine challenges for 90 minutes. The highest FEV1 at 5, 15, 30, 45, 60, and 90 minutes following methacholine challenge were evaluated for each subject. The minimum highest FEV1 was derived using the first three available measures that cover the first 30 minutes after the challenge.
Measured: Screening (Day -21 to Day -1) and Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 201328 Feb 2014

First posted25 Nov 2013 (estimated)
Study start16 Dec 2013
Primary completion20 Feb 2014
Study completion28 Feb 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.
Other trials for AsthmaStudies 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: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01993329
Sponsor's protocol ID: 7264-009
Other IDs: AF219-009, 2013-003566-13, MK-7264-009
Status last verified: Jan 2021
First submitted: 15 Nov 2013
Last updated: 3 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Three-Way Cross-over Study to Evaluate the Effect of AF-219 on Methacholine Hyper-Reactivity in Subjects With Asthma
ClinicalTrials.gov ID: NCT01993329
Acronym / sponsor ID: 7264-009
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
Study start: 16 Dec 2013 (actual)
Primary completion: 20 Feb 2014 (actual)
Study completion: 28 Feb 2014 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 3 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Gefapixant 50/ Gefapixant 300/ Placebo	Experimental	Drug: Gefapixant 50 mg, Drug: Gefapixant 300 mg, Drug: Placebo to mimic 50 mg tablets, Drug: Placebo to mimic 300 mg tabletsGefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 1, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 2, placebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Gefapixant 50/ Placebo/ Gefapixant 300	Experimental	Drug: Gefapixant 50 mg, Drug: Gefapixant 300 mg, Drug: Placebo to mimic 50 mg tablets, Drug: Placebo to mimic 300 mg tabletsGefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 1, placebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 2, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Gefapixant 300/ Gefapixant 50/ Placebo	Experimental	Drug: Gefapixant 50 mg, Drug: Gefapixant 300 mg, Drug: Placebo to mimic 50 mg tablets, Drug: Placebo to mimic 300 mg tabletsGefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 1, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 2, placebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Gefapixant 300/ Placebo/ Gefapixant 50	Experimental	Drug: Gefapixant 50 mg, Drug: Gefapixant 300 mg, Drug: Placebo to mimic 50 mg tablets, Drug: Placebo to mimic 300 mg tabletsGefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 1, placebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 2, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Placebo/ Gefapixant 50/ Gefapixant 300	Experimental	Drug: Gefapixant 50 mg, Drug: Gefapixant 300 mg, Drug: Placebo to mimic 50 mg tablets, Drug: Placebo to mimic 300 mg tabletsPlacebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 1, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 2, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.
Placebo/ Gefapixant 300/ Gefapixant 50	Experimental	Drug: Gefapixant 50 mg, Drug: Gefapixant 300 mg, Drug: Placebo to mimic 50 mg tablets, Drug: Placebo to mimic 300 mg tabletsPlacebo to match gefapixant 50 mg and placebo to match gefapixant 300 mg twice daily for 3.5 days during Period 1, gefapixant 300 mg and placebo (for gefapixant 50 mg) twice daily for 3.5 days during Period 2, gefapixant 50 mg and placebo (for gefapixant 300 mg) twice daily for 3.5 days during Period 3. Each period is separated by at least a 7-day wash-out period.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Women of child-bearing potential (WOCBP) (i.e., women who are not surgically sterile, not having had hysterectomy, bilateral tubal occlusion or bilateral oophorectomy, or are not postmenopausal) must have a negative pregnancy test at Screening and prior to randomization. WOCBP must be using 2 forms of acceptable birth control method from Screening through the Follow-Up Visit. Acceptable birth control methods include (of which 2 must be used):
Non-smokers or former smokers, who stopped smoking 6 months prior to screening. Former smokers should not have a smoking history of more than 5 pack years (1 pack of 20 cigarettes per day over 5 years).
Physician documented history or diagnosis of asthma for at least 6 months prior to screening according to the Global Initiative in Asthma guidelines (GINA, 2012).
Requires the use of Short acting β2-agonist therapy only (≤ 8 puffs per day) for at least 4 weeks prior to screening and prior to randomization.

Key exclusion criteria (22 listed)

Has been hospitalized or attended the emergency department for an asthma attack in the 12 months prior to screening.
Exacerbation of asthma or lower respiratory tract infection during the 4 weeks before screening or prior to randomization.
Upper respiratory tract infection during the 4 weeks before screening or prior to randomization requiring treatment with antibiotics.
Inhaled or systemic corticosteroids (oral, intravenous, intramuscular) within 4 weeks prior to screening or prior to randomization.
Short-acting or long-acting antihistamines within 48hrs or 7 days, respectively, prior to screening.

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
Gefapixant 50 mgAlso: AF-219, MK-7264Gefapixant 50 mg tablet administered orally	Drug	Gefapixant 300/ Gefapixant 50/ Placebo, Gefapixant 300/ Placebo/ Gefapixant 50, Gefapixant 50/ Gefapixant 300/ Placebo, Gefapixant 50/ Placebo/ Gefapixant 300, Placebo/ Gefapixant 300/ Gefapixant 50, Placebo/ Gefapixant 50/ Gefapixant 300
Gefapixant 300 mgAlso: AF-219, MK-7264Gefapixant 300 mg tablet administered orally	Drug	Gefapixant 300/ Gefapixant 50/ Placebo, Gefapixant 300/ Placebo/ Gefapixant 50, Gefapixant 50/ Gefapixant 300/ Placebo, Gefapixant 50/ Placebo/ Gefapixant 300, Placebo/ Gefapixant 300/ Gefapixant 50, Placebo/ Gefapixant 50/ Gefapixant 300
Placebo to mimic 50 mg tabletsSugar pill manufactured to mimic gefapixant 50 mg tablets	Drug	Gefapixant 300/ Gefapixant 50/ Placebo, Gefapixant 300/ Placebo/ Gefapixant 50, Gefapixant 50/ Gefapixant 300/ Placebo, Gefapixant 50/ Placebo/ Gefapixant 300, Placebo/ Gefapixant 300/ Gefapixant 50, Placebo/ Gefapixant 50/ Gefapixant 300
Placebo to mimic 300 mg tabletsSugar pill manufactured to mimic gefapixant 300 mg tablets	Drug	Gefapixant 300/ Gefapixant 50/ Placebo, Gefapixant 300/ Placebo/ Gefapixant 50, Gefapixant 50/ Gefapixant 300/ Placebo, Gefapixant 50/ Placebo/ Gefapixant 300, Placebo/ Gefapixant 300/ Gefapixant 50, Placebo/ Gefapixant 50/ Gefapixant 300

Primary outcome

Provocative Concentration (PC20) After Methacholine Challenge
Time frame: Screening (Day -21 to Day -1) and Day 3
The provocative concentration (PC) of inhaled methacholine required to reduce forced expiratory volume in 1 second (FEV1) by 20% (PC20) was calculated from the methacholine challenge at screening and 2 hours (+15 minutes) post dose on Day 3 of each Treatment Period using a five-breath dosimeter method. The primary endpoint was the methacholine PC20 value normalized by means of a log (base 2) transformation, at 2 dose levels compared with placebo in participants with asthma following provocation with methacholine.

1 secondary outcome

Highest FEV1 After Methacholine Challenge
Time frame: Screening (Day -21 to Day -1) and Day 3

Results and safety

Results posted to the registry on 3 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gefapixant 50 mg>Gefapixant 300 mg>Placebo	3	3
Gefapixant 50 mg>Placebo>Gefapixant 300 mg	4	4
Gefapixant 300 mg>Gefapixant 50 mg>Placebo	3	3
Gefapixant 300 mg>Placebo>Gefapixant 50 mg	3	3
Placebo> Gefapixant 50 mg>Gefapixant 300 mg	3	3
Placebo> Gefapixant 300 mg>Gefapixant 50 mg	4	4

Primary outcome: Provocative Concentration (PC20) After Methacholine Challenge

Time frame: Screening (Day -21 to Day -1) and Day 3. Geometric mean (Geometric Coefficient of Variation). Unit: log [mg/mL]

Measure	Gefapixant 50 n = 18	Gefapixant 300 n = 18	Placebo n = 18
Value	0.91 (214.4)	0.84 (181.0)	0.82 (260.1)

Gefapixant 50 vs Placebo: Geometric means ratio: 1.108 (95% CI 0.734 to 1.673), p = 0.616, ANOVA
Gefapixant 300 vs Placebo: Geometric means ratio: 1.016 (95% CI 0.673 to 1.534), p = 0.939, ANOVA
Gefapixant 50 vs Gefapixant 300: Geometric means ratio: 0.917 (95% CI 0.607 to 1.384), p = 0.671, ANOVA

Population analysed: Analysis population included all randomized participants who received at least 1 dose of study medication and had any post-dose efficacy evaluations for a given Treatment Period and who completed all 3 Treatment Periods.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 42 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gefapixant 50 mg	0 of 19 (0%)	16 of 19 (84.2%)	0 of 20
Gefapixant 300 mg	0 of 19 (0%)	19 of 19 (100%)	0 of 20
Placebo	0 of 20 (0%)	8 of 20 (40%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gefapixant 50 mg and Gefapixant 300 mg in people with Asthma, run by Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

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 10 inclusion and 22 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 3 Feb 2021. 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. 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 3 Feb 2021). 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?

Provocative Concentration (PC20) After Methacholine Challenge (time frame: Screening (Day -21 to Day -1) and Day 3). 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 NCT01993329.

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 3 Feb 2021.