CROMOLYN COMPOSITIONS FOR TREATMENT OF CHRONIC COUGH DUE TO IDIOPATHIC PULMONARY FIBROSIS
The disclosure provides a method of treating chronic cough in a subject having idiopathic pulmonary fibrosis (IPF) comprising administering to the subject a pharmaceutical composition comprising from about 2% by weight to about 6% by weight of cromolyn sodium and an ionic osmotic agent with a nebulizer.
1 . A method of treating chronic cough in a subject having idiopathic pulmonary fibrosis, comprising administering to the subject a pharmaceutical composition comprising cromolyn sodium with an inhalation device.
2 . The method according to claim 1 , wherein the pharmaceutical composition is administered to the subject from once to five times per day.
3 . The method according to claim 1 , wherein the pharmaceutical composition is administered to the subject three times per day.
4 . The method according to claim 2 , wherein the pharmaceutical composition is administered to the subject for 14 days or more.
5 . The method according to claim 1 , wherein the subject experiences a reduction in coughs per hour following administration of the pharmaceutical composition to the subject.
6 . The method according to claim 5 , wherein the subject experiences a reduction in nighttime coughs per hour following administration of the pharmaceutical composition to the subject.
7 . The method of claim 1 , wherein the inhalation device is selected from a nebulizer, a metered dose inhaler, a dry powder inhaler, a jet nebulizer, an ultrasonic wave nebulizer, a heat vaporizer, and a soft mist inhaler.
8 . The method of claim 7 , wherein the inhalation device is selected from a nebulizer, a metered dose inhaler, a dry powder inhaler, and a jet nebulizer.
9 . The method of claim 8 , wherein the inhalation device is selected from a nebulizer, a dry powder inhaler, and a jet nebulizer.
10 . The method of claim 9 , wherein the inhalation device is a nebulizer or a dry powder inhaler.
11 . The method of claim 10 , wherein the inhalation device is a nebulizer/
12 . The method of claim 11 , wherein the inhalation device is a dry powder inhaler.
13 . The method of claim 1 , wherein the pharmaceutical composition comprises from about 5 mg to about 80 mg of cromolyn sodium, inclusive of the endpoints.
14 . The method of claim 1 , wherein administration of the pharmaceutical composition to the subject produces in the subject an AUC (0-∞) of the cromolyn sodium greater than about 100 ng*hr/mL.
15 . The method of claim 1 , wherein administration of the pharmaceutical composition to the subject produces in the subject a C max of the cromolyn sodium greater than about 80 ng/mL.
16 . The method of claim 1 , wherein the pharmaceutical composition comprises from about 2% to about 6% by weight of cromolyn sodium.
17 . The method of claim 16 , wherein the pharmaceutical composition comprises about 2% by weight of cromolyn sodium.
18 . The method of claim 16 , wherein the pharmaceutical composition comprises about 4% by weight of cromolyn sodium.
19 . The method of claim 16 , wherein the pharmaceutical composition comprises about 6% by weight of cromolyn sodium.