To assess the efficacy of inhaled RVT-1601 in comparison with placebo following 12 weeks of treatment
ID
Source
Brief title
Condition
- Lower respiratory tract disorders (excl obstruction and infection)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change from baseline at the end of treatment in 24-hour average cough count
Secondary outcome
• Change from baseline at the end of treatment in cough severity as measured by
VAS
• Change from baseline at the end of treatment in cough-specific QoL as
measured by LCQ
• Proportion of responders with a minimum of 20% decrease from baseline at the
end of treatment in 24-hour average cough count
• Change from baseline at the end of treatment in daytime average cough count
• Change from baseline at the end of treatment in nighttime average cough count
• Change from baseline at the end of treatment in ILD-specific QoL as measured
by K-BILD
• Change from baseline at the end of treatment in respiratory-related QoL as
measured by SGRQ
• Change from baseline at the end of treatment in dyspnea score as measured by
SOBQ
• Change from baseline at the end of treatment in 6MWT
• Change from baseline at the end of treatment in FVC
• Proportion of subjects with no decline (i.e., < 5% decline), 5% - 10%
decline, and > 10% decline in FVC % predicted at the end of treatment
• Change from baseline at the end of treatment in airway and lung volumes as
measured by FRI
• Change from baseline at the end of treatment in average daily oxygen use
• Change from baseline at the end of treatment in exploratory biomarkers
Background summary
Idiopathic pulmonary fibrosis (IPF) is a progressive life-threatening disease
that is characterized anatomically by scarring of the lungs and symptomatically
by exertional dyspnea and dry cough.
Cough affects approximately three quarters of IPF cases.
Respivant is developing inhaled RVT-1601 for the treatment of persistent cough
in patients with IPF.
RVT-1601 is a new inhalation formulation of cromolyn sodium delivered via the
eFlow® Closed System (CS) nebulizer. Delivering RVT-1601 with the eFlow
nebulizer system achieves higher lung deposition of cromolyn sodium relative to
the currently marketed inhalation formulation of cromolyn sodium
Cromolyn sodium, with its well-established safety profile, is expected to play
a therapeutic role in the treatment of persistent cough.
Study objective
To assess the efficacy of inhaled RVT-1601 in comparison with placebo following
12 weeks of treatment
Study design
a two part, multi-center, Phase 2b study
Intervention
RVT-1601 delivered via the eFlow® nebulizer for the Treatment of Persistent
Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF)
Study burden and risks
IPF is a progressive life-threatening disease that is characterized
anatomically by scarring of the lungs and symptomatically by exertional dyspnea
and cough, and has a median survival of 3-5 years.
Cromolyn sodium is considered a unique anti-asthma medication because of its
extensive clinical and nonclinical record of safety. Historically, side effects
are rare, minor, and reversible.
RVT-1601 formulation achieves significantly higher lung deposition and systemic
bioavailability and, thus, a potential treatment of diseases and conditions
requiring high tissue concentrations of cromolyn sodium.
Viaduktstrasse 8
Basel 4051
CH
Viaduktstrasse 8
Basel 4051
CH
Listed location countries
Age
Inclusion criteria
1. Male or female subjects age 40 through 89 years, inclusive
2. Confirmed diagnosis of IPF with clinical features consistent with the
current clinical practice guidelines for IPF
3. Presence of persistent cough for at least 8 weeks that is primarily due to
IPF and not responsive to antitussive therapy
4. Daytime cough severity score of >=40 mm on a 100-mm VAS at the Screening
Visit
5. 24-hour average cough count of at least 10 coughs per hour using an
objective cough count monitor during Screening
6. Forced Vital Capacity (FVC) >= 45% predicted value within 4 weeks of the
Screening Visit
7. Life expectancy of at least 12 months
8. Willing and able to follow the study required visits and assessments.
9. Willing and able to use the cough monitor for 24-hour periods at select
study visits
11. Willing and able to provide written informed consent prior to study-related
procedures
Exclusion criteria
1. Current or recent history of clinically significant medical condition,
laboratory abnormality, or illness that could place the subject at risk or
compromise the quality of the study data as determined by the investigator
2. Significant coronary artery disease (i.e., myocardial infarction within 6
months or unstable angina within 1 month of the Screening Visit)
3. An upper or lower respiratory tract infection within 4 weeks of the
Screening Visit
4. Acute exacerbation of IPF within 6 months of the Screening Visit (Collard et
al., 2016)
5. Lung transplantation expected within 12 months
6. Requiring supplemental O2 >= 4 litres/min to maintain peripheral arterial O2
saturation (SpO2) >= 88% at rest
7. History of malignancy likely to result in significant disability or likely
to require significant medical or surgical intervention within the next 2
years. This does not include minor surgical procedures for localized cancer
(e.g., basal cell carcinoma, squamous cell, prostate carcinoma or cervical
carcinoma in situ)
8. Current smoker (i.e., use of tobacco products within the last 3 months)
9. Current or recent history of drug or alcohol abuse within 12 months of the
Screening Visit
10. Participation in any other investigational drug study within 4 weeks of the
Screening Visit or within 5 times the elimination half-life of an
investigational drug
11. Use of the following drugs for cough management within 4 weeks of the
Screening Visit: prednisone, opiates, baclofen, gabapentin, pregabalin,
thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators
12. Use of ACE inhibitors or cromolyn sodium within 4 weeks of the Screening
Visit
13. Females who are pregnant or breastfeeding, or if of child-bearing potential
unwilling to practice acceptable means of birth control during the study (e.g.,
abstinence, combination barrier and spermicide, hormonal, or male partner
sterilization)
14. History of hypersensitivity or intolerance to cromolyn sodium or its
inactive ingredients
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2018-004447-23-NL |
| CCMO | NL68590.056.19 |