DDrare: Database of Drug Development for Rare Diseases

ID	Disease name (Link within this page)	Number of trials
299	Cystic fibrosis	2

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2016-004033-25-ES (EUCTR)	19/06/2017	31/03/2017	Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosis	Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial	Cystic Fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10074550;Term: Preventive antimicrobial therapy in cystic fibrosis;System Organ Class: 100000004865 MedDRA version: 20.0;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]	Product Name: Sodium bicarbonate INN or Proposed INN: Sodium Bicarbonate Other descriptive name: SODIUM BICARBONATE BP Product Name: sodium chloride INN or Proposed INN: Sodium chloride Other descriptive name: SODIUM CHLORIDE Product Name: sodium chloride INN or Proposed INN: Sodium chloride Other descriptive name: SODIUM CHLORIDE Product Name: Water for injections INN or Proposed INN: water for injections Other descriptive name: WATER FOR INJECTIONS, EP	Fundació Parc Taulí	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 2	Spain
2	NCT00177645 (ClinicalTrials.gov)	March 2002	13/9/2005	Inhaled Bicarbonate Therapy in Cystic Fibrosis	Inhaled Bicarbonate Therapy in Cystic Fibrosis	Cystic Fibrosis	Procedure: sodium bicarbonate	University of Pittsburgh	Cystic Fibrosis Foundation Therapeutics;Children's Hospital of Pittsburgh	Completed	12 Years	N/A	Both	16	Phase 1	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2016-004033-25-ES
(EUCTR)

19/06/2017

31/03/2017

Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosis

Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial

Cystic Fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10074550;Term: Preventive antimicrobial therapy in cystic fibrosis;System Organ Class: 100000004865
MedDRA version: 20.0;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Product Name: Sodium bicarbonate
INN or Proposed INN: Sodium Bicarbonate
Other descriptive name: SODIUM BICARBONATE BP
Product Name: sodium chloride
INN or Proposed INN: Sodium chloride
Other descriptive name: SODIUM CHLORIDE
Product Name: sodium chloride
INN or Proposed INN: Sodium chloride
Other descriptive name: SODIUM CHLORIDE
Product Name: Water for injections
INN or Proposed INN: water for injections
Other descriptive name: WATER FOR INJECTIONS, EP

Fundació Parc Taulí

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2

Spain

NCT00177645
(ClinicalTrials.gov)

March 2002

13/9/2005

Inhaled Bicarbonate Therapy in Cystic Fibrosis

Cystic Fibrosis

Procedure: sodium bicarbonate

University of Pittsburgh

Cystic Fibrosis Foundation Therapeutics;Children's Hospital of Pittsburgh

Completed

12 Years

N/A

Both

Phase 1

United States