NCT02412020

Brief Summary

This is a double-blind, randomized, placebo-controlled, 2-period crossover, 2-cohort study in adult patients with refractory chronic cough. The purpose of the study is to assess the efficacy and safety of inhaled PA101 delivered via eFlow high efficiency nebulizer for treating refractory chronic cough.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_2

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

April 3, 2015

Last Update Submit

February 18, 2016

Conditions

Refractory Chronic Cough

Outcome Measures

Primary Outcomes (1)

  • cough frequency

    objective 24-hour cough monitoring

    14 days

Secondary Outcomes (2)

  • cough severity

    14 days

  • cough-related quality of life

    14 days

Study Arms (2)

PA101

EXPERIMENTAL

PA101, 40 mg administered via inhalation three times daily for 14 days

Drug: PA101Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo PA101, administered via inhalation three times daily for 14 days

Drug: PA101Drug: Placebo

Interventions

PA101DRUG
PA101Placebo
PlaceboDRUG
PA101Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Idiopathic Pulmonary Fibrosis (based on presence of definitive or possible usual interstitial pneumonia UIP pattern on high-resolution computed tomography and after excluding lung diseases associated with environmental and occupational exposure, with connective tissue disease and with drugs; transfer capacity for carbon monoxide corrected for hemoglobin \[TLCOc\] \>25% predicted within 12 months of Screening; and forced vital capacity \[FRC\] \>50% predicted within 1 month of Screening) or Chronic Idiopathic Cough (that is unresponsive to targeted treatment for identified underlying triggers including post-nasal drip, asthmatic/non-asthmatic eosinophilic bronchitis, and gastro-esophageal reflux disease)
  • Refractory chronic cough for at least 8 weeks
  • Daytime cough severity score \>40 mm on Cough Severity VAS at Screening
  • Daytime average cough count ≥15 per hour at Screening
  • Willing and able to provide written informed consent

You may not qualify if:

  • Current or recent history of clinically significant medical condition, laboratory abnormality or illness that could put the patient at risk or compromise the quality of the study data as determined by the investigator
  • Upper or lower respiratory tract infection within 4 weeks of Screening
  • History of malignancy treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma or cervix carcinoma in situ
  • Current or recent history (within 12 months) of excessive use or abuse of alcohol
  • Current or recent history (within 12 months) of abusing legal drugs or use of illegal drugs or substances
  • Participation in any other investigational drug study within 4 weeks of Screening
  • Use of prednisone, narcotic antitussives, baclofen, gabapentin, inhaled corticosteroids, benzonatate, dextromethorphan, carbetapentane, H1 antihistamines, leukotriene modifiers, and cromolyn sodium within 2 weeks of Screening
  • Pregnant or breastfeeding females, or if of child-bearing potential unwilling to practice acceptable means of birth control or abstinence during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Erasmus Medical Center

Rotterdam, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Hull Clinical Trials Unit

Cottingham, East Yorkshire, United Kingdom

Location

Uni Hospital Leicester

Leicester, United Kingdom

Location

King's College Hospital

London, United Kingdom

Location

Royal Brompton & Harefield Hospital

London, United Kingdom

Location

Uni Hospital North Staffordshire

Stoke-on-Trent, United Kingdom

Location

Related Publications (1)

  • Birring SS, Wijsenbeek MS, Agrawal S, van den Berg JWK, Stone H, Maher TM, Tutuncu A, Morice AH. A novel formulation of inhaled sodium cromoglicate (PA101) in idiopathic pulmonary fibrosis and chronic cough: a randomised, double-blind, proof-of-concept, phase 2 trial. Lancet Respir Med. 2017 Oct;5(10):806-815. doi: 10.1016/S2213-2600(17)30310-7. Epub 2017 Sep 8.

    PMID: 28923239DERIVED

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

CoughRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 8, 2015

Study Start

February 1, 2015

Primary Completion

January 1, 2016

Study Completion

February 1, 2016

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

NL(2)GB(5)